Trial Outcomes & Findings for Study of Efficacy, Safety, and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment (NCT NCT03200717)

NCT ID: NCT03200717

Last Updated: 2023-08-21

Results Overview

PFS is defined as the time from the start date of pazopanib treatment to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event (disease progression or death due to any cause) was observed prior to the analysis cut-off date. The PFS distribution was estimated using the Kaplan-Meier method.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 62 participants
• Primary outcome timeframe: Date of first treatment to date of progression or death up to approximately 38 months
• Results posted on: 2023-08-21

Participant Flow

The study was conducted across 22 centers in 11 countries

A total of 87 participants were screened of which 62 participants were enrolled in the this study to receive study treatment.

Participant milestones

Measure	Pazopanib- 2nd Line Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line Participants received pazopanib as 3rd line treatment
Overall Study STARTED	47	15
Overall Study COMPLETED	6	0
Overall Study NOT COMPLETED	41	15

Reasons for withdrawal

Measure	Pazopanib- 2nd Line Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line Participants received pazopanib as 3rd line treatment
Overall Study Progressive disease	24	5
Overall Study Adverse Event	11	8
Overall Study Physician Decision	3	2
Overall Study Death	2	0
Overall Study Subject/Guardian Decision	1	0

Baseline Characteristics

Study of Efficacy, Safety, and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment

Baseline characteristics by cohort

Measure	Pazopanib- 2nd Line n=47 Participants Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line n=15 Participants Participants received pazopanib as 3rd line treatment	Total n=62 Participants Total of all reporting groups
Age, Continuous	62.4 Years STANDARD_DEVIATION 11.55 • n=5 Participants	65.4 Years STANDARD_DEVIATION 9.77 • n=7 Participants	63.2 Years STANDARD_DEVIATION 11.15 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	11 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized White	44 Participants n=5 Participants	13 Participants n=7 Participants	57 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Date of first treatment to date of progression or death up to approximately 38 months

Population: Full Analysis Set (FAS): all subjects to whom study treatment has been assigned and who received at least one dose of pazopanib.

PFS is defined as the time from the start date of pazopanib treatment to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1.

PFS was censored at the date of the last adequate tumor assessment if no PFS event (disease progression or death due to any cause) was observed prior to the analysis cut-off date.

The PFS distribution was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Pazopanib- 2nd Line n=47 Participants Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line n=15 Participants Participants received pazopanib as 3rd line treatment	All Participants n=62 Participants All participants who received pazopanib as 2nd or 3rd line treatment
Progression Free Survival (PFS)	7.5 Months Interval 3.7 to 12.6	4.6 Months Interval 3.3 to 9.2	6.8 Months Interval 3.7 to 11.1

SECONDARY outcome

Timeframe: Up to approximately 38 months

Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib.

ORR is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method.

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	Pazopanib- 2nd Line n=47 Participants Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line n=15 Participants Participants received pazopanib as 3rd line treatment	All Participants n=62 Participants All participants who received pazopanib as 2nd or 3rd line treatment
Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1	23.4 Percentage of participants Interval 12.3 to 38.0	0 Percentage of participants Interval 0.0 to 21.8	17.7 Percentage of participants Interval 9.2 to 29.5

SECONDARY outcome

Timeframe: Up to approximately 38 months

Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib.

CBR is defined as the percentage of participants with a best overall response of CR or PR or an overall lesion response of stable disease (SD) or Non-CR/Non-PD lasting ≥ 24 weeks based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method.

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	Pazopanib- 2nd Line n=47 Participants Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line n=15 Participants Participants received pazopanib as 3rd line treatment	All Participants n=62 Participants All participants who received pazopanib as 2nd or 3rd line treatment
Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1.	53.2 Percentage of participants Interval 38.1 to 67.9	40.0 Percentage of participants Interval 16.3 to 67.7	50.0 Percentage of participants Interval 37.0 to 63.0

SECONDARY outcome

Timeframe: From date of first treatment to date of death, up to approximately 44 months

Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib

OS is defined as the time from the first administration of study treatment until death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive.

The OS distribution was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Pazopanib- 2nd Line n=47 Participants Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line n=15 Participants Participants received pazopanib as 3rd line treatment	All Participants n=62 Participants All participants who received pazopanib as 2nd or 3rd line treatment
Overall Survival (OS)	27.8 Months Interval 14.9 to NA: Not estimable due to insufficient follow-up time	20.0 Months Interval 9.2 to 25.6	23.4 Months Interval 14.9 to 31.8

SECONDARY outcome

Timeframe: From the date of first documented response (confirmed CR or PR) to the date of tumor progression, up to approximately 36 months

Population: Participants in the Full Analysis Set (FAS) for whom best overall response is complete response (CR) or partial response (PR)

DOR is defined as the time from the date of first documented response (confirmed CR or PR according to RECIST v1.1 based on local Investigators review of tumor assessment data) to the date of tumor progression, or death due to underlying cancer, whichever comes first.

If a patient not had an event, duration was censored at the date of last adequate tumor assessment.

The DOR distribution was calculated using the Kaplan-Meier method.

Outcome measures

Measure	Pazopanib- 2nd Line n=11 Participants Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line Participants received pazopanib as 3rd line treatment	All Participants All participants who received pazopanib as 2nd or 3rd line treatment
Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1	NA Months Interval 9.5 to NA: Not estimable due to insufficient number of participants with events	—	—

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days

Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. Number analyzed indicates participants with data available for analyses at the given timepoint.

FKSI-DRS is a 9-item questionnaire specifically designed to evaluate symptoms that are directly attributable to kidney cancer and includes patient's symptoms in the past seven days such as lack of energy, pain, bone-pain, shortness of breath, fatigue, blood in urine, etc. Each item is scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (no symptoms) to 36 (most severe symptoms) with a higher score indicating greater presence of kidney cancer symptoms.

The baseline is defined as the last FKSI-DRS assessment on or prior to first day of treatment.

A negative change from baseline indicates improvement in kidney cancer symptom status.

Outcome measures

Measure	Pazopanib- 2nd Line n=47 Participants Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line n=15 Participants Participants received pazopanib as 3rd line treatment	All Participants n=62 Participants All participants who received pazopanib as 2nd or 3rd line treatment
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 25 Day 1	2.0 Score on a scale Standard Deviation 2.31	—	2.0 Score on a scale Standard Deviation 2.31
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 2 Day 1	-1.3 Score on a scale Standard Deviation 4.95	-0.3 Score on a scale Standard Deviation 4.31	-1.0 Score on a scale Standard Deviation 4.78
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 3 Day 1	-0.5 Score on a scale Standard Deviation 4.55	1.7 Score on a scale Standard Deviation 4.18	-0.0 Score on a scale Standard Deviation 4.51
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 4 Day 1	-0.1 Score on a scale Standard Deviation 2.97	1.8 Score on a scale Standard Deviation 4.22	0.2 Score on a scale Standard Deviation 3.24
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 5 Day 1	0.1 Score on a scale Standard Deviation 3.13	2.0 Score on a scale Standard Deviation 2.35	0.4 Score on a scale Standard Deviation 3.06
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 6 Day 1	-0.3 Score on a scale Standard Deviation 5.68	2.7 Score on a scale Standard Deviation 3.27	0.3 Score on a scale Standard Deviation 5.36
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 7 Day 1	-0.1 Score on a scale Standard Deviation 3.47	2.5 Score on a scale Standard Deviation 3.73	0.4 Score on a scale Standard Deviation 3.63
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 9 Day 1	-0.1 Score on a scale Standard Deviation 4.22	—	-0.1 Score on a scale Standard Deviation 4.22
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 11 Day 1	0.7 Score on a scale Standard Deviation 3.30	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	0.6 Score on a scale Standard Deviation 3.20
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 13 Day 1	1.4 Score on a scale Standard Deviation 2.12	—	1.4 Score on a scale Standard Deviation 2.12
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 16 Day 1	0.6 Score on a scale Standard Deviation 1.59	—	0.6 Score on a scale Standard Deviation 1.59
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 19 Day 1	0.0 Score on a scale Standard Deviation 2.76	—	0.0 Score on a scale Standard Deviation 2.76
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 22 Day 1	-0.5 Score on a scale Standard Deviation 3.27	—	-0.5 Score on a scale Standard Deviation 3.27
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 31 Day 1	0.5 Score on a scale Standard Deviation 0.71	—	0.5 Score on a scale Standard Deviation 0.71
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 34 Day 1	1.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant	—	1.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score Cycle 37 Day 1	1.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant	—	1 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score End of Treatment	-0.6 Score on a scale Standard Deviation 3.86	-0.8 Score on a scale Standard Deviation 6.00	-0.6 Score on a scale Standard Deviation 4.37

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days

Population: Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. Number analyzed indicates participants with data available for analyses at the given timepoint.

EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ-5L-5D VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating higher health-related quality of life.

The baseline is defined as the last EQ-5L-5D assessment on or prior to first day of treatment.

A positive change from baseline indicates improvement in the heath state.

Outcome measures

Measure	Pazopanib- 2nd Line n=47 Participants Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line n=15 Participants Participants received pazopanib as 3rd line treatment	All Participants n=62 Participants All participants who received pazopanib as 2nd or 3rd line treatment
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 2 Day 1	0.1 Score on a scale Standard Deviation 16.44	-1.9 Score on a scale Standard Deviation 19.46	-0.4 Score on a scale Standard Deviation 17.02
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 3 Day 1	-2.8 Score on a scale Standard Deviation 14.35	3.6 Score on a scale Standard Deviation 19.28	-1.3 Score on a scale Standard Deviation 15.58
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 4 Day 1	-0.7 Score on a scale Standard Deviation 10.88	-1.5 Score on a scale Standard Deviation 22.86	-0.8 Score on a scale Standard Deviation 13.27
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 5 Day 1	-1.5 Score on a scale Standard Deviation 13.61	3.2 Score on a scale Standard Deviation 19.51	-0.7 Score on a scale Standard Deviation 14.45
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 6 Day 1	-1.3 Score on a scale Standard Deviation 18.35	-3.5 Score on a scale Standard Deviation 24.09	-1.7 Score on a scale Standard Deviation 19.21
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 7 Day 1	0.2 Score on a scale Standard Deviation 11.89	0.7 Score on a scale Standard Deviation 20.37	0.3 Score on a scale Standard Deviation 13.73
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 9 Day 1	3.8 Score on a scale Standard Deviation 11.64	—	3.8 Score on a scale Standard Deviation 11.64
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 11 Day 1	3.9 Score on a scale Standard Deviation 12.62	-2.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	3.5 Score on a scale Standard Deviation 12.30
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 13 Day 1	5.7 Score on a scale Standard Deviation 12.26	—	5.7 Score on a scale Standard Deviation 12.26
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 16 Day 1	-1.3 Score on a scale Standard Deviation 11.70	—	-1.3 Score on a scale Standard Deviation 11.70
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 19 Day 1	5.5 Score on a scale Standard Deviation 10.09	—	5.5 Score on a scale Standard Deviation 10.09
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 22 Day 1	0.5 Score on a scale Standard Deviation 9.93	—	0.5 Score on a scale Standard Deviation 9.93
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 25 Day 1	0.0 Score on a scale Standard Deviation 9.70	—	0.0 Score on a scale Standard Deviation 9.70
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 31 Day 1	99.5 Score on a scale Standard Deviation 0.71	—	99.5 Score on a scale Standard Deviation 0.71
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 34 Day 1	10.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—	10.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score Cycle 37 Day 1	90.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—	90.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score End of Treatment	-1.9 Score on a scale Standard Deviation 20.84	-8.9 Score on a scale Standard Deviation 19.99	-3.6 Score on a scale Standard Deviation 20.59

POST_HOC outcome

Timeframe: On-treatment deaths: Up to approximately 38 months. Post-treatment survival follow-up deaths: Up to approximately 44 months

Population: Participants who received at least one dose of pazopanib

On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication, for a maximum duration of approximately 38 months.

Post-treatment survival follow-up deaths were collected from day 31 after last dose of study medication to end of study, up to approximately 44 months.

All deaths refer to the sum of on-treatment deaths and post-treatment survival follow-up deaths.

Outcome measures

Measure	Pazopanib- 2nd Line n=47 Participants Participants received pazopanib as 2nd line treatment	Pazopanib- 3rd Line n=15 Participants Participants received pazopanib as 3rd line treatment	All Participants n=62 Participants All participants who received pazopanib as 2nd or 3rd line treatment
All Collected Deaths On-treatment deaths	5 Participants	1 Participants	6 Participants
All Collected Deaths Post-treatment survival follow-up deaths	22 Participants	10 Participants	32 Participants
All Collected Deaths All deaths	27 Participants	11 Participants	38 Participants

Adverse Events

Pazopanib- 2nd Line (On-Treatment)

Serious events: 21 serious events

Other events: 46 other events

Deaths: 5 deaths

Pazopanib- 3rd Line (On-Treatment)

Serious events: 9 serious events

Other events: 14 other events

Deaths: 1 deaths

Pazopanib- 2nd Line (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 22 deaths

Pazopanib- 3rd Line (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Measure	Pazopanib- 2nd Line (On-Treatment) n=47 participants at risk AEs during on-treatment period (up to 30 days post-treatment)	Pazopanib- 3rd Line (On-Treatment) n=15 participants at risk AEs collected during on-treatment period (up to 30 days post- treatment)	Pazopanib- 2nd Line (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	Pazopanib- 3rd Line (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	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Cardiac disorders Atrial flutter	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Ascites	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Diarrhoea	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Vomiting	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
General disorders Chest pain	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
General disorders Pyrexia	4.3% 2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Hepatobiliary disorders Hepatotoxicity	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Immune system disorders Immune system disorder	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Infections and infestations Bronchitis viral	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Infections and infestations Meningitis bacterial	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Infections and infestations Pulmonary sepsis	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Infections and infestations Urinary tract infection	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Infections and infestations Viral infection	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Injury, poisoning and procedural complications Hip fracture	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Injury, poisoning and procedural complications Spinal fracture	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Injury, poisoning and procedural complications Wound haemorrhage	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Alanine aminotransferase increased	4.3% 2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Blood bilirubin increased	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Transaminases increased	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Back pain	4.3% 2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Nervous system disorders Cerebrovascular accident	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Nervous system disorders Dizziness	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Nervous system disorders Spinal cord compression	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Renal and urinary disorders Acute kidney injury	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Renal and urinary disorders Renal failure	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Pemphigoid	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Vascular disorders Hypertension	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Vascular disorders Vasculitis	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.

Other adverse events

Measure	Pazopanib- 2nd Line (On-Treatment) n=47 participants at risk AEs during on-treatment period (up to 30 days post-treatment)	Pazopanib- 3rd Line (On-Treatment) n=15 participants at risk AEs collected during on-treatment period (up to 30 days post- treatment)	Pazopanib- 2nd Line (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	Pazopanib- 3rd Line (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	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Blood and lymphatic system disorders Thrombocytopenia	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Endocrine disorders Hypothyroidism	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Eye disorders Lacrimation increased	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Abdominal pain	10.6% 5/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Abdominal pain upper	10.6% 5/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Constipation	10.6% 5/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Diarrhoea	51.1% 24/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	40.0% 6/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Enterocolitis	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Gastritis	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Haemorrhoids	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Nausea	25.5% 12/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	26.7% 4/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Rectal haemorrhage	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Stomatitis	12.8% 6/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Vomiting	12.8% 6/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
General disorders Asthenia	12.8% 6/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
General disorders Fatigue	31.9% 15/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	53.3% 8/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
General disorders Gait disturbance	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
General disorders Oedema peripheral	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
General disorders Pain	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
General disorders Peripheral swelling	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
General disorders Pyrexia	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Hepatobiliary disorders Hepatotoxicity	8.5% 4/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Infections and infestations Lower respiratory tract infection	4.3% 2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Infections and infestations Nasopharyngitis	4.3% 2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Infections and infestations Rhinitis	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Infections and infestations Upper respiratory tract infection	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Injury, poisoning and procedural complications Fall	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Alanine aminotransferase increased	14.9% 7/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	33.3% 5/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Aspartate aminotransferase increased	10.6% 5/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	26.7% 4/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Blood alkaline phosphatase increased	4.3% 2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	26.7% 4/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Blood bilirubin increased	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	26.7% 4/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Blood creatine phosphokinase increased	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Blood creatinine increased	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Blood glucose increased	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Blood urea increased	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Gamma-glutamyltransferase increased	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Lipase increased	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Platelet count decreased	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Serum ferritin increased	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Transaminases increased	4.3% 2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Troponin T increased	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Investigations Weight decreased	17.0% 8/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Decreased appetite	29.8% 14/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	8.5% 4/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Back pain	10.6% 5/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Muscle spasms	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Nervous system disorders Dizziness	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Nervous system disorders Dysgeusia	10.6% 5/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	33.3% 5/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Nervous system disorders Headache	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Nervous system disorders Lethargy	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Psychiatric disorders Depression	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Renal and urinary disorders Dysuria	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Renal and urinary disorders Proteinuria	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	8.5% 4/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Dysphonia	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.3% 2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Alopecia	2.1% 1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Erythema	4.3% 2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	10.6% 5/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Pruritus	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Rash	6.4% 3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Vascular disorders Hypertension	27.7% 13/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
Vascular disorders Hypotension	0.00% 0/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that 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 (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER