Trial Outcomes & Findings for Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation (NCT NCT04427072)

NCT ID: NCT04427072

Last Updated: 2025-05-16

Results Overview

Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by BIRC according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 22 participants
• Primary outcome timeframe: From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months
• Results posted on: 2025-05-16

Participant Flow

All inclusion and exclusion criteria were checked at screening.

Participant milestones

Measure	Capmatinib 400 mg, capmatinib tablets, administered orally twice daily	Capmatinib Extension Crossover Treatment 400 mg, capmatinib tablets, administered orally twice daily to participants treated with docetaxel who crossed over to capmatinib treatment.
Randomized Treatment Phase STARTED	15	7
Randomized Treatment Phase Treated	15	6
Randomized Treatment Phase COMPLETED	0	0
Randomized Treatment Phase NOT COMPLETED	15	7
Extension Treatment Phase STARTED	0	5
Extension Treatment Phase COMPLETED	0	0
Extension Treatment Phase NOT COMPLETED	0	5

Reasons for withdrawal

Measure	Capmatinib 400 mg, capmatinib tablets, administered orally twice daily	Capmatinib Extension Crossover Treatment 400 mg, capmatinib tablets, administered orally twice daily to participants treated with docetaxel who crossed over to capmatinib treatment.
Randomized Treatment Phase Progressive disease	9	4
Randomized Treatment Phase Adverse Event	3	1
Randomized Treatment Phase Study terminated by sponsor	3	0
Randomized Treatment Phase Death	0	1
Randomized Treatment Phase Not treated (participant decision)	0	1
Extension Treatment Phase Progressive disease	0	5

Baseline Characteristics

Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

Baseline characteristics by cohort

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle	Total n=22 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 9.26 • n=5 Participants	65.1 years STANDARD_DEVIATION 4.98 • n=7 Participants	66.8 years STANDARD_DEVIATION 8.10 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White	11 participants n=5 Participants	6 participants n=7 Participants	17 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.

Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by BIRC according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Progression-free Survival (PFS) Per Blinded Independent Review Committee (BIRC) Using RECIST v1.1	6.1 months Interval 1.61 to 13.77	4.1 months Interval 1.22 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.

Percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR), assessed by BIRC according to RECIST 1.1. 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; 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	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Overall Response (ORR) Per RECIST 1.1 by BIRC	53.3 percentage of participants Interval 26.59 to 78.73	0 percentage of participants Interval 0.0 to 40.96

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.

Percentage of participants with confirmed BOR of CR or PR, assessed by local review according to RECIST 1.1. 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; 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	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Overall Response Rate (ORR) Per RECIST 1.1 by Investigator	46.7 percentage of participants Interval 21.27 to 73.41	14.3 percentage of participants Interval 0.36 to 57.87

SECONDARY outcome

Timeframe: From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only.

Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by BIRC according to RECIST 1.1. 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; 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	Capmatinib n=8 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Time to Response (TTR) Per RECIST 1.1 by BIRC	3.2 months Interval 1.2 to 15.3	—

SECONDARY outcome

Timeframe: From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only.

Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by local review according to RECIST 1.1. 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; 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	Capmatinib n=7 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=1 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Time to Response (TTR) Per RECIST 1.1 by Investigator	1.3 months Interval 1.2 to 15.5	2.8 months Interval 2.8 to 2.8

SECONDARY outcome

Timeframe: From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only.

Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by BIRC per RECIST 1.1 or death due to any cause. 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; 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	Capmatinib n=8 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Duration of Response (DOR) Per RECIST 1.1 by BIRC	12.6 months Interval 2.92 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with response.	—

SECONDARY outcome

Timeframe: From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only.

Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by local review per RECIST 1.1 or death due to any cause. 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; 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	Capmatinib n=7 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=1 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Duration of Response (DOR) Per RECIST 1.1 by Investigator	9.9 months Interval 2.92 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with response.	3.1 months 95% confidence interval was not calculable for a single participant.

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.

Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by BIRC according to RECIST 1.1. 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; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Disease Control Rate (DCR) Per RECIST 1.1 by BIRC	73.3 percentage of participants Interval 44.9 to 92.21	57.1 percentage of participants Interval 18.41 to 90.1

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.

Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by local review according to RECIST 1.1. 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; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Disease Control Rate (DCR) Per RECIST 1.1 by Investigator	86.7 percentage of participants Interval 59.54 to 98.34	42.9 percentage of participants Interval 9.9 to 81.59

SECONDARY outcome

Timeframe: From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.

Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by local review according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Progression-free Survival (PFS) Per Investigator Using RECIST v1.1	6.1 months Interval 2.66 to 11.1	3.6 months Interval 1.22 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: From randomization to death due to any cause, assessed up to approximately 36 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.

OS was defined as the time from the date of randomization to the date of death due to any cause.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Overall Survival (OS)	12.5 months Interval 4.3 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	13.6 months Interval 2.6 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The full analysis set - brain metastases (FAS-BM) comprised all participants in the FAS who had measurable and/or non-measurable brain metastases at baseline as determined by the BIRC and at least one post-baseline assessment. The FAS-BM was used in the analyses of intracranial anti-tumor activity per RANO-BM criteria. Data are reported for responders only.

Percentage of participants with confirmed best overall intracranial response (BOIR) of CR or partial response (PR), as assessed by BIRC review per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose.

Outcome measures

Measure	Capmatinib n=1 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Overall Intracranial Response Rate (OIRR)	0 Percentage of participants Interval 0.0 to 97.5	—

SECONDARY outcome

Timeframe: From date of first documented intracranial response (CR or PR) to first documented intracranial progression, assessed up to approximately 21 months

Population: The duration of intracranial response could not be analyzed as there were no participants with intracranial response. The analysis population was all participants with intracranial response.

Time from date of first documented intracranial response (CR or PR) to first documented intracranial progression per RANO-BM assessed by BIRC or date of death due to underlying cause of cancer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization to first documented intracranial response of either CR or PR, assessed up to approximately 21 months

Population: The median time to intracranial response was not evaluable in both treatment arms as there were no responders.

Time from date of randomization to first documented intracranial response of either CR or PR, per RANO-BM criteria and assessed by BIRC, which must be subsequently confirmed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The full analysis set - brain metastases (FAS-BM) comprised all participants in the FAS who had measurable and/or non-measurable brain metastases at baseline as determined by the BIRC and at least one post-baseline assessment. The FAS-BM was used in the analyses of intracranial anti-tumor activity per RANO-BM criteria. Data are reported for responders only.

Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) (or non-CR/non-PD) per RANO-BM, assessed by BIRC. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose.

Outcome measures

Measure	Capmatinib n=1 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Intracranial Disease Control Rate (IDCR)	100 percentage of participants Interval 2.5 to 100.0	—

SECONDARY outcome

Timeframe: Cycle (C) 1 Day (D) 15 pre-dose, 1 and 4 hours post-dose, C3 D1 pre-dose. Each cycle duration was 21 days.

Population: The pharmacokinetic analysis set (PAS) included all participants who received at least one dose of capmatinib and had at least one steady state evaluable post-baseline capmatinib concentration measurement.

Plasma concentrations of capmatinib. Blood samples were collected at indicated time points for pharmacokinetic analysis.

Outcome measures

Measure	Capmatinib n=14 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Plasma Capmatinib Concentration Cycle 1, Day 15, 0 hour n=12	496 μg/mL Geometric Coefficient of Variation 97.3	—
Plasma Capmatinib Concentration Cycle 1, Day 15, 1 hour n=10	1330 μg/mL Geometric Coefficient of Variation 214.6	—
Plasma Capmatinib Concentration Cycle 1, Day 15, 4 hours n=11	2680 μg/mL Geometric Coefficient of Variation 131.1	—
Plasma Capmatinib Concentration Cycle 3, Day 1, 0 hour n=10	243 μg/mL Geometric Coefficient of Variation 140.6	—

SECONDARY outcome

Timeframe: Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for participants with baseline and respective post-baseline measurements.

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. CFB = change from baseline.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 23, Day 1 n=2,0	25.0 score on a scale Standard Deviation 35.36	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 25, Day 1 n=2,0	16.7 score on a scale Standard Deviation 70.71	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 27, Day 1 n=2,0	33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 29, Day 1 n=2,0	-16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 3, Day 1 n=12,4	-13.9 score on a scale Standard Deviation 33.21	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 5, Day 1 n=8,3	-12.5 score on a scale Standard Deviation 30.54	11.1 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 7, Day 1 n=8,1	-4.2 score on a scale Standard Deviation 27.82	-33.3 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 3, Day 1 n=12,4	-13.9 score on a scale Standard Deviation 26.43	8.3 score on a scale Standard Deviation 31.91
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 5, Day 1 n=8,3	0.0 score on a scale Standard Deviation 25.20	-22.2 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 9, Day 1 n=7,2	-4.8 score on a scale Standard Deviation 23.00	16.7 score on a scale Standard Deviation 23.57
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 11, Day 1 n=7,0	14.3 score on a scale Standard Deviation 37.80	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 13, Day 1 n=5,0	6.7 score on a scale Standard Deviation 27.89	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 15, Day 1 n=5,0	20.0 score on a scale Standard Deviation 29.81	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 17, Day 1 n=4,0	8.3 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 19, Day 1 n=5,0	13.3 score on a scale Standard Deviation 29.81	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 21, Day 1 n=	16.7 score on a scale Standard Deviation 43.03	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 23, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 25, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 3, Day 1 n=12,4	17.4 score on a scale Standard Deviation 18.96	4.2 score on a scale Standard Deviation 14.43
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 5, Day 1 n=8,3	14.6 score on a scale Standard Deviation 22.16	8.3 score on a scale Standard Deviation 14.43
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 7, Day 1 n=8,1	15.6 score on a scale Standard Deviation 16.33	-8.3 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 9, Day 1 n=7,2	9.5 score on a scale Standard Deviation 16.96	0.0 score on a scale Standard Deviation 11.79
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 11, Day 1 n=7,0	3.6 score on a scale Standard Deviation 15.85	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 13, Day 1 n=5,0	25.0 score on a scale Standard Deviation 10.21	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 15, Day 1 n=5,0	10.0 score on a scale Standard Deviation 10.87	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 17, Day 1 n=4,0	18.8 score on a scale Standard Deviation 10.49	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 19, Day 1 n=5,0	-1.7 score on a scale Standard Deviation 19.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 21, Day 1 n=4,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 23, Day 1 n=2,0	-8.3 score on a scale Standard Deviation 11.79	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 25, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Global Health Status CFB at Cycle 29, Day 1 n=2,0	-29.2 score on a scale Standard Deviation 29.46	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 3, Day 1 n=12,4	11.1 score on a scale Standard Deviation 24.01	-1.7 score on a scale Standard Deviation 6.38
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 5, Day 1 n=8,3	15.0 score on a scale Standard Deviation 21.89	-13.3 score on a scale Standard Deviation 23.09
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 7, Day 1 n=8,1	4.2 score on a scale Standard Deviation 26.41	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 9, Day 1 n=7,2	7.6 score on a scale Standard Deviation 22.25	3.3 score on a scale Standard Deviation 14.14
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 11, Day 1 n=7,0	-1.9 score on a scale Standard Deviation 25.74	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 13, Day 1 n=5,0	5.3 score on a scale Standard Deviation 25.99	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 15, Day 1 n=5,0	-1.3 score on a scale Standard Deviation 15.92	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 17, Day 1 n=4,0	-5.0 score on a scale Standard Deviation 13.74	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 19, Day 1 n=5,0	-2.7 score on a scale Standard Deviation 32.52	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 21, Day 1 n=4,0	5.0 score on a scale Standard Deviation 10.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 23, Day 1 n=2,0	0.0 score on a scale Standard Deviation 9.43	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 25, Day 1 n=2,0	13.3 score on a scale Standard Deviation 9.43	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 27, Day 1 n=2,0	3.3 score on a scale Standard Deviation 4.71	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Physical Functioning CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 28.28	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 3, Day 1 n=12,4	20.8 score on a scale Standard Deviation 22.61	-4.2 score on a scale Standard Deviation 20.97
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 5, Day 1 n=8,3	20.8 score on a scale Standard Deviation 29.21	-5.6 score on a scale Standard Deviation 25.46
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 7, Day 1 n=8,1	18.8 score on a scale Standard Deviation 28.78	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 9, Day 1 n=7,2	14.3 score on a scale Standard Deviation 22.42	-8.3 score on a scale Standard Deviation 11.79
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 11, Day 1 n=7,0	7.1 score on a scale Standard Deviation 26.97	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 13, Day 1 n=5,0	13.3 score on a scale Standard Deviation 21.73	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 15, Day 1 n=5,0	26.7 score on a scale Standard Deviation 19.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 17, Day 1 n=4,0	0.0 score on a scale Standard Deviation 13.61	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 19, Day 1 n=5,0	16.7 score on a scale Standard Deviation 50.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 21, Day 1 n=4,0	8.3 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 23, Day 1 n=2,0	8.3 score on a scale Standard Deviation 11.79	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 25, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Role Functioning CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 3, Day 1 n=12,4	15.3 score on a scale Standard Deviation 32.14	2.1 score on a scale Standard Deviation 7.98
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 5, Day 1 n=8,3	15.6 score on a scale Standard Deviation 31.32	11.1 score on a scale Standard Deviation 17.35
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 7, Day 1 n=8,1	12.5 score on a scale Standard Deviation 34.21	-16.7 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 9, Day 1 n=7,2	8.3 score on a scale Standard Deviation 36.00	-8.3 score on a scale Standard Deviation 11.79
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 11, Day 1 n=7,0	1.2 score on a scale Standard Deviation 23.29	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 13, Day 1 n=5,0	18.3 score on a scale Standard Deviation 25.28	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 15, Day 1 n=5,0	16.7 score on a scale Standard Deviation 19.54	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 17, Day 1 n=4,0	8.3 score on a scale Standard Deviation 11.79	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 19, Day 1 n=5,0	15.0 score on a scale Standard Deviation 21.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 21, Day 1 n=4,0	16.7 score on a scale Standard Deviation 15.21	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 23, Day 1 n=2,0	0.0 score on a scale Standard Deviation 11.79	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 25, Day 1 n=2,0	8.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 27, Day 1 n=2,0	-8.3 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Emotional Functioning CFB at Cycle 29, Day 1 n=2,0	8.3 score on a scale Standard Deviation 35.36	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 3, Day 1 n=12,4	12.5 score on a scale Standard Deviation 23.70	-8.3 score on a scale Standard Deviation 9.62
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 5, Day 1 n=8,3	6.3 score on a scale Standard Deviation 29.46	0.0 score on a scale Standard Deviation 16.67
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 7, Day 1 n=8,1	6.3 score on a scale Standard Deviation 33.26	16.7 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Dyspnea CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 9, Day 1 n=7,2	7.1 score on a scale Standard Deviation 21.21	8.3 score on a scale Standard Deviation 11.79
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 11, Day 1 n=7,0	4.8 score on a scale Standard Deviation 23.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 13, Day 1 n=5,0	20.0 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 15, Day 1 n=5,0	16.7 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 17, Day 1 n=4,0	8.3 score on a scale Standard Deviation 21.52	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 19, Day 1 n=5,0	16.7 score on a scale Standard Deviation 28.87	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 21, Day 1 n=4,0	0.0 score on a scale Standard Deviation 13.61	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 23, Day 1 n=2,0	8.3 score on a scale Standard Deviation 35.36	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 25, Day 1 n=2,0	0.0 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 27, Day 1 n=2,0	-8.3 score on a scale Standard Deviation 35.36	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Cognitive Functioning CFB at Cycle 29, Day 1 n=2,0	41.7 score on a scale Standard Deviation 11.79	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 3, Day 1 n=12,4	18.1 score on a scale Standard Deviation 37.91	-4.2 score on a scale Standard Deviation 25.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 5, Day 1 n=8,3	12.5 score on a scale Standard Deviation 44.32	-22.2 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 7, Day 1 n=8,1	-2.1 score on a scale Standard Deviation 37.20	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 9, Day 1 n=7,2	0.0 score on a scale Standard Deviation 33.33	0.0 score on a scale Standard Deviation 47.14
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 11, Day 1 n=7,0	-2.4 score on a scale Standard Deviation 35.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 13, Day 1 n=5,0	23.3 score on a scale Standard Deviation 25.28	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 15, Day 1 n=5,0	10.0 score on a scale Standard Deviation 25.28	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 17, Day 1 n=4,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 19, Day 1 n=5,0	-13.3 score on a scale Standard Deviation 13.94	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 21, Day 1 n=4,0	-16.7 score on a scale Standard Deviation 13.61	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 23, Day 1 n=2,0	-8.3 score on a scale Standard Deviation 11.79	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 25, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 27, Day 1 n=2,0	-16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Social Functioning CFB at Cycle 29, Day 1 n=2,0	-8.3 score on a scale Standard Deviation 11.79	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 3, Day 1 n=12,4	-11.1 score on a scale Standard Deviation 31.43	-11.1 score on a scale Standard Deviation 9.07
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 5, Day 1 n=8,3	-12.5 score on a scale Standard Deviation 27.50	-14.8 score on a scale Standard Deviation 23.13
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 7, Day 1 n=8,1	-12.5 score on a scale Standard Deviation 29.36	-22.2 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 9, Day 1 n=7,2	-12.7 score on a scale Standard Deviation 25.20	-11.1 score on a scale Standard Deviation 15.71
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 11, Day 1 n=7,0	-7.9 score on a scale Standard Deviation 27.75	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 13, Day 1 n=5,0	-13.3 score on a scale Standard Deviation 27.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 15, Day 1 n=5,0	-15.6 score on a scale Standard Deviation 16.85	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 17, Day 1 n=4,0	-5.6 score on a scale Standard Deviation 14.34	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 19, Day 1 n=5,0	-4.4 score on a scale Standard Deviation 26.76	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 21, Day 1 n=4,0	-11.1 score on a scale Standard Deviation 15.71	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 23, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.0	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 25, Day 1 n=2,0	-16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 27, Day 1 n=2,0	5.6 score on a scale Standard Deviation 7.86	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Fatigue CFB at Cycle 29, Day 1 n=2,0	11.1 score on a scale Standard Deviation 31.43	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 3, Day 1 n=12,4	-1.4 score on a scale Standard Deviation 21.86	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 5, Day 1 n=8,3	-6.3 score on a scale Standard Deviation 26.63	11.1 score on a scale Standard Deviation 9.62
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 7, Day 1 n=8,1	20.8 score on a scale Standard Deviation 39.59	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 9, Day 1 n=7,2	0.0 score on a scale Standard Deviation 23.57	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 11, Day 1 n=7,0	4.8 score on a scale Standard Deviation 28.41	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 13, Day 1 n=5,0	-3.3 score on a scale Standard Deviation 7.45	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 15, Day 1 n=5,0	0.0 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 17, Day 1 n=4,0	8.3 score on a scale Standard Deviation 31.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 19, Day 1 n=5,0	20.0 score on a scale Standard Deviation 49.16	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 21, Day 1 n=4,0	20.8 score on a scale Standard Deviation 34.36	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 23, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 25, Day 1 n=2,0	8.3 score on a scale Standard Deviation 35.36	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 27, Day 1 n=2,0	16.7 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Nausea and Vomiting CFB at Cycle 29, Day 1 n=2,0	8.3 score on a scale Standard Deviation 35.36	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 3, Day 1 n=12,4	-4.2 score on a scale Standard Deviation 41.51	-25.0 score on a scale Standard Deviation 16.67
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 5, Day 1 n=8,3	-2.1 score on a scale Standard Deviation 31.42	5.6 score on a scale Standard Deviation 38.49
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 7, Day 1 n=8,1	-4.2 score on a scale Standard Deviation 42.49	-16.7 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 9, Day 1 n=7,2	-4.8 score on a scale Standard Deviation 29.99	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 11, Day 1 n=7,0	4.8 score on a scale Standard Deviation 50.66	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 13, Day 1 n=5,0	0.0 score on a scale Standard Deviation 54.01	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 15, Day 1 n=5,0	-6.7 score on a scale Standard Deviation 40.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 17, Day 1 n=4,0	12.5 score on a scale Standard Deviation 77.43	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 19, Day 1 n=5,0	6.7 score on a scale Standard Deviation 63.03	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Pain CFB at Cycle 21, Day 1 n=4,0	4.2 score on a scale Standard Deviation 43.83	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 7, Day 1 n=8,1	-8.3 score on a scale Standard Deviation 34.50	-33.3 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 9, Day 1 n=7,2	-4.8 score on a scale Standard Deviation 35.63	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 11, Day 1 n=7,0	0.0 score on a scale Standard Deviation 38.49	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 13, Day 1 n=5,0	0.0 score on a scale Standard Deviation 33.33	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 15, Day 1 n=5,0	-13.3 score on a scale Standard Deviation 38.01	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 17, Day 1 n=4,0	16.7 score on a scale Standard Deviation 43.03	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 19, Day 1 n=5,0	-6.7 score on a scale Standard Deviation 49.44	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 21, Day 1 n=4,0	0.0 score on a scale Standard Deviation 72.01	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 23, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 25, Day 1 n=2,0	-16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Insomnia CFB at Cycle 29, Day 1 n=2,0	16.7 score on a scale Standard Deviation 70.71	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 3, Day 1 n=12,4	-16.7 score on a scale Standard Deviation 38.92	-8.3 score on a scale Standard Deviation 16.67
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 5, Day 1 n=8,3	4.2 score on a scale Standard Deviation 41.55	-11.1 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 7, Day 1 n=8,1	-12.5 score on a scale Standard Deviation 24.80	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 9, Day 1 n=7,2	-19.0 score on a scale Standard Deviation 32.53	0.0 score on a scale Standard Deviation 47.14
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 11, Day 1 n=7,0	-14.3 score on a scale Standard Deviation 42.41	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 13, Day 1 n=5,0	-40.0 score on a scale Standard Deviation 36.51	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 15, Day 1 n=5,0	-33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 17, Day 1 n=4,0	-33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 19, Day 1 n=5,0	-13.3 score on a scale Standard Deviation 73.03	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 21, Day 1 n=4,0	-33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 23, Day 1 n=2,0	-16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 25, Day 1 n=2,0	-16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 27, Day 1 n=2,0	-33.3 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Appetite Loss CFB at Cycle 29, Day 1 n=2,0	-33.3 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 3, Day 1 n=12,4	2.8 score on a scale Standard Deviation 38.82	-16.7 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 5, Day 1 n=8,3	-12.5 score on a scale Standard Deviation 35.36	0.0 score on a scale Standard Deviation 33.33
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 7, Day 1 n=8,1	-4.2 score on a scale Standard Deviation 54.74	-33.3 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 9, Day 1 n=7,2	14.3 score on a scale Standard Deviation 26.23	-33.3 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 11, Day 1 n=7,0	-4.8 score on a scale Standard Deviation 44.84	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 13, Day 1 n=5,0	-20.0 score on a scale Standard Deviation 44.72	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 15, Day 1 n=5,0	-6.7 score on a scale Standard Deviation 54.77	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 17, Day 1 n=4,0	-16.7 score on a scale Standard Deviation 57.74	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 19, Day 1 n=5,0	-26.7 score on a scale Standard Deviation 43.46	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 21, Day 1 n=4,0	-16.7 score on a scale Standard Deviation 57.74	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 23, Day 1 n=2,0	33.3 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 25, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 27, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Constipation CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 3, Day 1 n=12,4	0.0 score on a scale Standard Deviation 24.62	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 5, Day 1 n=8,3	-4.2 score on a scale Standard Deviation 11.79	-22.2 score on a scale Standard Deviation 38.49
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 7, Day 1 n=8,1	0.0 score on a scale Standard Deviation 17.82	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 9, Day 1 n=7,2	14.3 score on a scale Standard Deviation 17.82	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 11, Day 1 n=7,0	4.8 score on a scale Standard Deviation 12.60	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 13, Day 1 n=5,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 15, Day 1 n=5,0	6.7 score on a scale Standard Deviation 14.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 17, Day 1 n=4,0	16.7 score on a scale Standard Deviation 33.33	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 19, Day 1 n=5,0	13.3 score on a scale Standard Deviation 29.81	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 21, Day 1 n=4,0	8.3 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 23, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 25, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 27, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Diarrhea CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 3, Day 1 n=12,4	-2.8 score on a scale Standard Deviation 26.43	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 5, Day 1 n=8,3	-8.3 score on a scale Standard Deviation 29.55	-11.1 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 7, Day 1 n=8,1	-4.2 score on a scale Standard Deviation 21.36	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 9, Day 1 n=7,2	0.0 score on a scale Standard Deviation 33.33	-33.3 score on a scale Standard Deviation 47.14
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 11, Day 1 n=7,0	0.0 score on a scale Standard Deviation 19.25	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 13, Day 1 n=5,0	0.0 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 15, Day 1 n=5,0	13.3 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 17, Day 1 n=4,0	-8.3 score on a scale Standard Deviation 31.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 19, Day 1 n=5,0	13.3 score on a scale Standard Deviation 29.81	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 21, Day 1 n=4,0	25.0 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 23, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 25, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 27, Day 1 n=2,0	33.3 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Financial Difficulties CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—

SECONDARY outcome

Timeframe: Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for participants with baseline and respective post-baseline measurements.

EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included coughing, hemoptysis, dyspnea, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, and pain in other parts and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from "not at all" to "very much." Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. CFB = change from baseline.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 5, Day 1 n=8,3	-4.2 score on a scale Standard Deviation 11.79	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 13, Day 1 n=5,0	13.3 score on a scale Standard Deviation 29.81	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 3, Day 1 n=12,4	-19.4 score on a scale Standard Deviation 26.43	16.7 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 5, Day 1 n=8,3	-8.3 score on a scale Standard Deviation 23.57	11.1 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 7, Day 1 n=8,1	-20.8 score on a scale Standard Deviation 24.80	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 9, Day 1 n=7,2	-23.8 score on a scale Standard Deviation 25.20	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 11, Day 1 n=7,0	-9.5 score on a scale Standard Deviation 37.09	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 13, Day 1 n=5,0	-20.0 score on a scale Standard Deviation 29.81	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 15, Day 1 n=5,0	-6.7 score on a scale Standard Deviation 36.51	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 17, Day 1 n=4,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 19, Day 1 n=5,0	-6.7 score on a scale Standard Deviation 14.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 21, Day 1 n=4,0	-8.3 score on a scale Standard Deviation 41.94	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 23, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 25, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing CFB at Cycle 29, Day 1 n=2,0	-16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 3, Day 1 n=12,4	0.0 score on a scale Standard Deviation 0.00	8.3 score on a scale Standard Deviation 16.67
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 5, Day 1 n=8,3	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 7, Day 1 n=8,1	4.2 score on a scale Standard Deviation 11.79	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 9, Day 1 n=7,2	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 11, Day 1 n=7,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 13, Day 1 n=5,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 15, Day 1 n=5,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 17, Day 1 n=4,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 19, Day 1 n=5,0	13.3 score on a scale Standard Deviation 29.81	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 21, Day 1 n=4,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 23, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 25, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Hemoptysis CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 3, Day 1 n=12,4	-20.4 score on a scale Standard Deviation 21.10	0.0 score on a scale Standard Deviation 9.07
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 5, Day 1 n=8,3	-18.1 score on a scale Standard Deviation 17.76	14.8 score on a scale Standard Deviation 16.97
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 7, Day 1 n=8,1	-8.3 score on a scale Standard Deviation 29.55	11.1 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 9, Day 1 n=7,2	-14.3 score on a scale Standard Deviation 33.16	16.7 score on a scale Standard Deviation 23.57
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 11, Day 1 n=7,0	-4.8 score on a scale Standard Deviation 32.62	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 13, Day 1 n=5,0	-13.3 score on a scale Standard Deviation 31.82	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 15, Day 1 n=5,0	-11.1 score on a scale Standard Deviation 27.22	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 17, Day 1 n=4,0	0.0 score on a scale Standard Deviation 9.07	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 19, Day 1 n=5,0	6.7 score on a scale Standard Deviation 30.02	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 21, Day 1 n=4,0	-2.8 score on a scale Standard Deviation 36.71	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 23, Day 1 n=2,0	-5.6 score on a scale Standard Deviation 7.86	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 25, Day 1 n=2,0	-5.6 score on a scale Standard Deviation 7.86	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 27, Day 1 n=2,0	-5.6 score on a scale Standard Deviation 7.86	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 15.71	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 3, Day 1 n=12,4	-8.3 score on a scale Standard Deviation 25.13	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 7, Day 1 n=8,1	-4.2 score on a scale Standard Deviation 27.82	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 9, Day 1 n=7,2	9.5 score on a scale Standard Deviation 16.27	16.7 score on a scale Standard Deviation 23.57
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 11, Day 1 n=7,0	9.5 score on a scale Standard Deviation 16.27	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 13, Day 1 n=5,0	13.3 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 15, Day 1 n=5,0	13.3 score on a scale Standard Deviation 29.81	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 17, Day 1 n=4,0	16.7 score on a scale Standard Deviation 33.33	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 19, Day 1 n=5,0	33.3 score on a scale Standard Deviation 33.33	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 21, Day 1 n=4,0	8.3 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 23, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 25, Day 1 n=2,0	33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 27, Day 1 n=2,0	33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Sore Mouth CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 3, Day 1 n=12,4	0.0 score on a scale Standard Deviation 14.21	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 5, Day 1 n=8,3	8.3 score on a scale Standard Deviation 23.57	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 7, Day 1 n=8,1	12.5 score on a scale Standard Deviation 24.80	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 9, Day 1 n=7,2	4.8 score on a scale Standard Deviation 12.60	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 11, Day 1 n=7,0	9.5 score on a scale Standard Deviation 16.27	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 13, Day 1 n=5,0	6.7 score on a scale Standard Deviation 14.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 15, Day 1 n=5,0	13.3 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 17, Day 1 n=4,0	25.0 score on a scale Standard Deviation 31.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 19, Day 1 n=5,0	20.0 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 21, Day 1 n=4,0	25.0 score on a scale Standard Deviation 31.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 23, Day 1 n=2,0	33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 25, Day 1 n=2,0	33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 27, Day 1 n=2,0	33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dysphagia CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 3, Day 1 n=12,4	13.9 score on a scale Standard Deviation 26.43	8.3 score on a scale Standard Deviation 31.91
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 5, Day 1 n=8,3	-4.2 score on a scale Standard Deviation 11.79	11.1 score on a scale Standard Deviation 38.49
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 7, Day 1 n=8,1	20.8 score on a scale Standard Deviation 17.25	-33.3 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 9, Day 1 n=7,2	28.6 score on a scale Standard Deviation 23.00	-16.7 score on a scale Standard Deviation 23.57
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 11, Day 1 n=7,0	14.3 score on a scale Standard Deviation 17.82	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 13, Day 1 n=5,0	13.3 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 15, Day 1 n=5,0	6.7 score on a scale Standard Deviation 14.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 17, Day 1 n=4,0	8.3 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 19, Day 1 n=5,0	26.7 score on a scale Standard Deviation 43.46	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 21, Day 1 n=4,0	25.0 score on a scale Standard Deviation 31.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 23, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 25, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Peripheral Neuropathy CFB at Cycle 29, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 3, Day 1 n=12,4	-8.3 score on a scale Standard Deviation 20.72	41.7 score on a scale Standard Deviation 41.94
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 5, Day 1 n=8,3	-16.7 score on a scale Standard Deviation 17.82	22.2 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 7, Day 1 n=8,1	0.0 score on a scale Standard Deviation 25.20	-33.3 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 9, Day 1 n=7,2	0.0 score on a scale Standard Deviation 19.25	0.0 score on a scale Standard Deviation 47.14
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 11, Day 1 n=7,0	9.5 score on a scale Standard Deviation 31.71	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 15, Day 1 n=5,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 17, Day 1 n=4,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 19, Day 1 n=5,0	20.0 score on a scale Standard Deviation 29.81	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 21, Day 1 n=4,0	8.3 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 23, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 25, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Alopecia CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 3, Day 1 n=12,4	-19.4 score on a scale Standard Deviation 22.29	-8.3 score on a scale Standard Deviation 41.94
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 5, Day 1 n=8,3	-8.3 score on a scale Standard Deviation 29.55	-11.1 score on a scale Standard Deviation 50.92
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 7, Day 1 n=8,1	-25.0 score on a scale Standard Deviation 15.43	-33.3 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 9, Day 1 n=7,2	-23.8 score on a scale Standard Deviation 25.20	0.0 score on a scale Standard Deviation 47.14
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 11, Day 1 n=7,0	-4.8 score on a scale Standard Deviation 23.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 13, Day 1 n=5,0	-13.3 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 15, Day 1 n=5,0	-13.3 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 17, Day 1 n=4,0	0.0 score on a scale Standard Deviation 27.22	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 19, Day 1 n=5,0	-20.0 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 21, Day 1 n=4,0	0.0 score on a scale Standard Deviation 38.49	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 23, Day 1 n=2,0	33.3 score on a scale Standard Deviation 47.14	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 25, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 27, Day 1 n=2,0	16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Chest CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 3, Day 1 n=12,4	-2.8 score on a scale Standard Deviation 30.01	-33.3 score on a scale Standard Deviation 38.49
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 5, Day 1 n=8,3	-8.3 score on a scale Standard Deviation 15.43	-22.2 score on a scale Standard Deviation 19.25
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 7, Day 1 n=8,1	-8.3 score on a scale Standard Deviation 34.50	-33.3 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 9, Day 1 n=7,2	-9.5 score on a scale Standard Deviation 37.09	-16.7 score on a scale Standard Deviation 70.71
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 11, Day 1 n=7,0	-9.5 score on a scale Standard Deviation 53.45	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 13, Day 1 n=5,0	-6.7 score on a scale Standard Deviation 36.51	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 15, Day 1 n=5,0	-26.7 score on a scale Standard Deviation 49.44	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 17, Day 1 n=4,0	-16.7 score on a scale Standard Deviation 57.74	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 19, Day 1 n=5,0	-6.7 score on a scale Standard Deviation 59.63	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 21, Day 1 n=4,0	-25.0 score on a scale Standard Deviation 56.93	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 23, Day 1 n=2,0	-16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 25, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Arm or Shoulder CFB at Cycle 29, Day 1 n=2,0	-50.0 score on a scale Standard Deviation 70.71	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 3, Day 1 n=12,4	-8.3 score on a scale Standard Deviation 37.94	-8.3 score on a scale Standard Deviation 16.67
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 5, Day 1 n=8,3	-12.5 score on a scale Standard Deviation 17.25	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 7, Day 1 n=8,1	-12.5 score on a scale Standard Deviation 35.36	33.3 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 9, Day 1 n=7,2	-9.5 score on a scale Standard Deviation 16.27	16.7 score on a scale Standard Deviation 23.57
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 11, Day 1 n=7,0	4.8 score on a scale Standard Deviation 35.63	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 13, Day 1 n=5,0	-6.7 score on a scale Standard Deviation 14.91	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts at Cycle 15, Day 1 n=5,0	-13.3 score on a scale Standard Deviation 18.26	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 17, Day 1 n=4,0	16.7 score on a scale Standard Deviation 43.03	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 19, Day 1 n=5,0	20.0 score on a scale Standard Deviation 44.72	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 21, Day 1 n=	8.3 score on a scale Standard Deviation 16.67	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 23, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 25, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 27, Day 1 n=2,0	-16.7 score on a scale Standard Deviation 23.57	—
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in Other Parts CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—

SECONDARY outcome

Timeframe: Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for participants with baseline and respective post-baseline measurements.

EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients. The EQ-5D-5L consists of 2 parts- the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: from 1 (no problems) to 5 (extreme problems). The EQ VAS is a self-perceived health score assessed using a visual analogue scale that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility. CFB = change from baseline.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 3, Day 1 n=12,4	-0.6 score on a scale Standard Deviation 0.79	0.0 score on a scale Standard Deviation 0.82
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 5, Day 1 n=8,3	-0.3 score on a scale Standard Deviation 1.16	-0.7 score on a scale Standard Deviation 1.53
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 7, Day 1 n=8,1	-0.3 score on a scale Standard Deviation 1.39	-1.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 9, Day 1 n=7,2	0.0 score on a scale Standard Deviation 1.41	0.0 score on a scale Standard Deviation 1.41
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 11, Day 1 n=7,0	0.4 score on a scale Standard Deviation 0.98	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 13, Day 1 n=5,0	-0.4 score on a scale Standard Deviation 1.14	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 15, Day 1 n=5,0	-0.2 score on a scale Standard Deviation 1.10	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 17, Day 1 n=4,0	0.5 score on a scale Standard Deviation 1.29	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 19, Day 1 n=5,0	-0.2 score on a scale Standard Deviation 0.84	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 21, Day 1 n=4,0	0.5 score on a scale Standard Deviation 1.73	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 23, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 25, Day 1 n=2,0	-0.5 score on a scale Standard Deviation 0.71	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Anxiety/Depression CFB at Cycle 29, Day 1 n=2,0	0.5 score on a scale Standard Deviation 2.12	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 3, Day 1 n=12,4	11.7 score on a scale Standard Deviation 17.99	10.3 score on a scale Standard Deviation 11.32
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 5, Day 1 n=8,3	12.6 score on a scale Standard Deviation 12.47	10.3 score on a scale Standard Deviation 5.03
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 7, Day 1 n=8,1	7.6 score on a scale Standard Deviation 15.34	-6.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 9, Day 1 n=7,2	6.7 score on a scale Standard Deviation 18.29	5.0 score on a scale Standard Deviation 8.49
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 11, Day 1 n=7,0	-1.4 score on a scale Standard Deviation 14.36	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 13, Day 1 n=5,0	10.8 score on a scale Standard Deviation 21.23	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 15, Day 1 n=5,0	1.6 score on a scale Standard Deviation 10.88	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 17, Day 1 n=4,0	-4.5 score on a scale Standard Deviation 13.77	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 19, Day 1 n=5,0	2.0 score on a scale Standard Deviation 12.27	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 21, Day 1 n=4,0	-5.0 score on a scale Standard Deviation 10.80	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 23, Day 1 n=2,0	-7.5 score on a scale Standard Deviation 17.68	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 25, Day 1 n=2,0	-4.0 score on a scale Standard Deviation 26.87	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 27, Day 1 n=2,0	-17.0 score on a scale Standard Deviation 16.97	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire EQ VAS Score CFB at Cycle 29, Day 1 n=2,0	-16.5 score on a scale Standard Deviation 9.19	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 3, Day 1 n=12,4	-0.3 score on a scale Standard Deviation 0.89	0.3 score on a scale Standard Deviation 0.96
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 5, Day 1 n=8,3	0.1 score on a scale Standard Deviation 0.99	0.0 score on a scale Standard Deviation 1.00
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 7, Day 1 n=8,1	0.4 score on a scale Standard Deviation 1.06	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 9, Day 1 n=7,2	0.0 score on a scale Standard Deviation 0.82	1.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 11, Day 1 n=7,0	0.1 score on a scale Standard Deviation 1.57	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 13, Day 1 n=5,0	0.6 score on a scale Standard Deviation 1.52	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 15, Day 1 n=5,0	0.0 score on a scale Standard Deviation 1.58	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 17, Day 1 n=4,0	0.8 score on a scale Standard Deviation 2.22	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 19, Day 1 n=5,0	-0.2 score on a scale Standard Deviation 1.48	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 21, Day 1 n=4,0	0.3 score on a scale Standard Deviation 1.71	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 23, Day 1 n=2,0	2.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 25, Day 1 n=2,0	1.0 score on a scale Standard Deviation 1.41	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 27, Day 1 n=2,0	1.5 score on a scale Standard Deviation 0.71	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Pain/Discomfort CFB at Cycle 29, Day 1 n=2,0	0.5 score on a scale Standard Deviation 0.71	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 3, Day 1 n=12,4	-0.3 score on a scale Standard Deviation 0.75	-0.3 score on a scale Standard Deviation 0.96
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 5, Day 1 n=8,3	-0.4 score on a scale Standard Deviation 0.92	0.7 score on a scale Standard Deviation 1.53
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 7, Day 1 n=8,1	-0.1 score on a scale Standard Deviation 0.83	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 9, Day 1 n=7,2	-0.4 score on a scale Standard Deviation 0.98	1.0 score on a scale Standard Deviation 1.41
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 11, Day 1 n=7,0	-0.1 score on a scale Standard Deviation 1.07	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 13, Day 1 n=5,0	-0.2 score on a scale Standard Deviation 0.84	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 15, Day 1 n=5,0	0.2 score on a scale Standard Deviation 0.45	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 17, Day 1 n=4,0	0.3 score on a scale Standard Deviation 0.96	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 19, Day 1 n=5,0	0.0 score on a scale Standard Deviation 1.00	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 21, Day 1 n=4,0	-0.3 score on a scale Standard Deviation 0.96	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 23, Day 1 n=2,0	0.5 score on a scale Standard Deviation 0.71	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 25, Day 1 n=2,0	0.5 score on a scale Standard Deviation 0.71	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 27, Day 1 n=2,0	1.0 score on a scale Standard Deviation 1.41	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility CFB at Cycle 29, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 3, Day 1 n=12,4	-0.2 score on a scale Standard Deviation 0.72	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 5, Day 1 n=8,3	0.5 score on a scale Standard Deviation 0.76	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 7, Day 1 n=8,1	0.0 score on a scale Standard Deviation 1.20	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 9, Day 1 n=7,2	0.1 score on a scale Standard Deviation 1.35	0.0 score on a scale Standard Deviation 0.00
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 11, Day 1 n=7,0	0.1 score on a scale Standard Deviation 1.46	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 13, Day 1 n=5,0	0.0 score on a scale Standard Deviation 1.22	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 15, Day 1 n=5,0	0.0 score on a scale Standard Deviation 1.22	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 17, Day 1 n=4,0	0.0 score on a scale Standard Deviation 1.63	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 19, Day 1 n=5,0	0.0 score on a scale Standard Deviation 1.58	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 21, Day 1 n=4,0	-0.3 score on a scale Standard Deviation 1.71	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 23, Day 1 n=2,0	1.0 score on a scale Standard Deviation 1.41	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 25, Day 1 n=2,0	1.0 score on a scale Standard Deviation 1.41	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 27, Day 1 n=2,0	1.0 score on a scale Standard Deviation 1.41	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Self-Care CFB at Cycle 29, Day 1 n=2,0	-0.5 score on a scale Standard Deviation 0.71	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 3, Day 1 n=12,4	-0.7 score on a scale Standard Deviation 1.23	1.3 score on a scale Standard Deviation 0.50
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 5, Day 1 n=8,3	-0.9 score on a scale Standard Deviation 1.55	0.7 score on a scale Standard Deviation 0.58
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 7, Day 1 n=8,1	-0.8 score on a scale Standard Deviation 1.28	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 9, Day 1 n=7,2	-0.7 score on a scale Standard Deviation 0.95	1.5 score on a scale Standard Deviation 0.71
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 11, Day 1 n=7,0	-0.7 score on a scale Standard Deviation 1.38	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 13, Day 1 n=5,0	-0.8 score on a scale Standard Deviation 0.84	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 15, Day 1 n=5,0	-0.4 score on a scale Standard Deviation 0.55	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 17, Day 1 n=4,0	-0.3 score on a scale Standard Deviation 0.50	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 19, Day 1 n=5,0	-0.4 score on a scale Standard Deviation 0.55	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 21, Day 1 n=4,0	-0.8 score on a scale Standard Deviation 0.96	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 23, Day 1 n=2,0	0.5 score on a scale Standard Deviation 0.71	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 25, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 27, Day 1 n=2,0	0.0 score on a scale Standard Deviation 0.00	—
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Usual Activities CFB at Cycle 29, Day 1 n=2,0	1.0 score on a scale Standard Deviation 1.41	—

SECONDARY outcome

Timeframe: Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days.

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.

EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included chest pain, cough, and dyspnea and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from "not at all" to "very much." Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. Time to symptom deterioration for chest pain, cough and dyspnea was assessed. Deterioration was assessed by the investigator.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Coughing	13.9 months Interval 2.76 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	2.9 months Interval 1.38 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Dyspnea	5.7 months Interval 2.76 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	2.9 months Interval 1.38 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) Pain in chest	11.1 months Interval 2.76 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	2.9 months Interval 1.45 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days.

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Time to deterioration in QoL from EORTC-QLQ-C30 was assessed. Deterioration was assessed by the investigator.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=7 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30	NA months Interval 2.92 to The median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.	NA months Interval 1.38 to The median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.

POST_HOC outcome

Timeframe: On-treatment deaths: Up to approximately 117 weeks. Post-treatment survival follow-up deaths: Up to an additional 36 weeks.

Population: The safety set included all participants who received at least one dose of study treatment.

On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.

Outcome measures

Measure	Capmatinib n=15 Participants 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel n=6 Participants Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
All Collected Deaths On-treatment deaths	2 Participants	0 Participants
All Collected Deaths Post-treatment deaths	7 Participants	5 Participants
All Collected Deaths All deaths	9 Participants	5 Participants

Adverse Events

Capmatinib (On-treatment)

Serious events: 3 serious events

Other events: 14 other events

Deaths: 2 deaths

Docetaxel (On-treatment)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Capmatinib Extension Crossover Treatment (On-treatment)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Capmatinib (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Docetaxel (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Measure	Capmatinib (On-treatment) n=15 participants at risk 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel (On-treatment) n=6 participants at risk Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle	Capmatinib Extension Crossover Treatment (On-treatment) n=5 participants at risk 400 mg, capmatinib tablets, administered orally twice daily to participants treated with docetaxel who crossed over to capmatinib treatment.	Capmatinib (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Docetaxel (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
General disorders Chest pain	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Pain	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Respiratory tract infection	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Sepsis	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.

Other adverse events

Measure	Capmatinib (On-treatment) n=15 participants at risk 400 mg, capmatinib tablets, administered orally twice daily	Docetaxel (On-treatment) n=6 participants at risk Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle	Capmatinib Extension Crossover Treatment (On-treatment) n=5 participants at risk 400 mg, capmatinib tablets, administered orally twice daily to participants treated with docetaxel who crossed over to capmatinib treatment.	Capmatinib (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Docetaxel (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
Blood and lymphatic system disorders Anaemia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	50.0% 3/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	60.0% 3/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Cardiac disorders Atrial fibrillation	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Cardiac disorders Palpitations	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Cardiac disorders Pericardial effusion	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Cardiac disorders Supraventricular extrasystoles	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Cardiac disorders Tachycardia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Ear and labyrinth disorders Deafness	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Ear and labyrinth disorders Ear pain	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Ear and labyrinth disorders Hypoacusis	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Ear and labyrinth disorders Tinnitus	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Endocrine disorders Myxoedema	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Eye disorders Eye pruritus	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Eye disorders Eyelid oedema	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Eye disorders Lacrimation increased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	33.3% 2/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	40.0% 2/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Eye disorders Vitreous floaters	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Abdominal pain	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Abdominal pain upper	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Aphthous ulcer	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Constipation	26.7% 4/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Diarrhoea	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Dry mouth	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Dyspepsia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Faecaloma	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Flatulence	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Frequent bowel movements	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Gingival bleeding	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Nausea	33.3% 5/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Odynophagia	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Stomatitis	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Toothache	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Gastrointestinal disorders Vomiting	40.0% 6/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Asthenia	26.7% 4/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	33.3% 2/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	40.0% 2/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Fatigue	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Gait disturbance	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Mucosal inflammation	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Oedema	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Oedema peripheral	66.7% 10/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Peripheral swelling	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Pyrexia	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
General disorders Suprapubic pain	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Hepatobiliary disorders Hypertransaminasaemia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Bronchitis	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations COVID-19	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Conjunctivitis	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	33.3% 2/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	40.0% 2/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Eyelid infection	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Herpes zoster	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Influenza	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Nasopharyngitis	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Respiratory tract infection	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Rhinolaryngitis	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Infections and infestations Sinusitis	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Injury, poisoning and procedural complications Fall	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Alanine aminotransferase increased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Amylase increased	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Aspartate aminotransferase increased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Blood albumin decreased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Blood alkaline phosphatase increased	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Blood bilirubin increased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Blood cholesterol increased	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Blood creatinine increased	26.7% 4/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Blood lactate dehydrogenase increased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Creatinine renal clearance decreased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Creatinine renal clearance increased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Hepatic enzyme increased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Lipase increased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Lymphocyte count decreased	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Neutrophil count decreased	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Protein total decreased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Transaminases increased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Weight decreased	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations Weight increased	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Investigations White blood cell count decreased	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Metabolism and nutrition disorders Decreased appetite	26.7% 4/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Metabolism and nutrition disorders Fluid retention	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Metabolism and nutrition disorders Hyperkalaemia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Metabolism and nutrition disorders Hypoalbuminaemia	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Metabolism and nutrition disorders Hypocalcaemia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Metabolism and nutrition disorders Hypomagnesaemia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Metabolism and nutrition disorders Hyponatraemia	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Metabolism and nutrition disorders Hypoproteinaemia	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Back pain	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Muscle spasms	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Myalgia	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Osteoarthritis	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Osteochondrosis	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	33.3% 2/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	40.0% 2/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Pain in jaw	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Scoliosis	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Nervous system disorders Dizziness	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Nervous system disorders Dysgeusia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Nervous system disorders Headache	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Nervous system disorders Hypoaesthesia	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Nervous system disorders Neuropathy peripheral	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Nervous system disorders Paraesthesia	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Nervous system disorders Somnolence	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Psychiatric disorders Anxiety	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Psychiatric disorders Insomnia	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Renal and urinary disorders Dysuria	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Renal and urinary disorders Nocturia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Renal and urinary disorders Proteinuria	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Renal and urinary disorders Renal pain	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Reproductive system and breast disorders Penile dermatitis	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Reproductive system and breast disorders Perineal rash	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Aphonia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 5/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Dysphonia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Haemoptysis	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Alopecia	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	66.7% 4/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	80.0% 4/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Dermatosis	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	33.3% 2/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	40.0% 2/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Pain of skin	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Pruritus	20.0% 3/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Rash vesicular	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Vascular disorders Deep vein thrombosis	13.3% 2/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Vascular disorders Embolism	0.00% 0/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	16.7% 1/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	20.0% 1/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Vascular disorders Hypotension	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
Vascular disorders Lymphoedema	6.7% 1/15 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/6 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	0.00% 0/5 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.	— 0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 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 (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER