Trial Outcomes & Findings for A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC) (NCT NCT01235962)

Last Updated: 2020-11-23

Results Overview

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1538 participants

Primary outcome timeframe

approximately 5 years

Results posted on

2020-11-23

Participant Flow

The study was planned to include 1500 subjects. A total of 1538 subjects were enrolled and analyzed.

Participant milestones

Participant milestones
Measure	ITT Pazopanib 800 mg Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 800 mg Placebo matching pazopanib 800 mg daily. Complete treatment is 12 months.	ITT Pazopanib 600 mg Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.
Overall Study STARTED	198	205	571	564
Overall Study Prem. Withdrawn = Did Not Complete Study	46	35	118	86
Overall Study All Deaths	43	46	102	104
Overall Study COMPLETED	152	170	453	478
Overall Study NOT COMPLETED	46	35	118	86

Reasons for withdrawal

Reasons for withdrawal
Measure	ITT Pazopanib 800 mg Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 800 mg Placebo matching pazopanib 800 mg daily. Complete treatment is 12 months.	ITT Pazopanib 600 mg Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.
Overall Study Withdrawal by Subject	20	19	62	49
Overall Study Lost to Follow-up	21	16	47	32
Overall Study Physician Decision	5	0	9	5

Baseline Characteristics

A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ITT Pazopanib 800 mg n=198 Participants Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 800 mg n=205 Participants Placebo matching pazopanib 800 mg daily. Complete treatment is 12 months.	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Total n=1538 Participants Total of all reporting groups
Age, Customized =>18 to <65	154 Participants n=93 Participants	140 Participants n=4 Participants	430 Participants n=27 Participants	406 Participants n=483 Participants	1130 Participants n=36 Participants
Age, Customized =>65 to <75	36 Participants n=93 Participants	55 Participants n=4 Participants	122 Participants n=27 Participants	131 Participants n=483 Participants	344 Participants n=36 Participants
Age, Customized =>75 to <85	8 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants	27 Participants n=483 Participants	64 Participants n=36 Participants
Sex: Female, Male Female	59 Participants n=93 Participants	51 Participants n=4 Participants	173 Participants n=27 Participants	164 Participants n=483 Participants	447 Participants n=36 Participants
Sex: Female, Male Male	139 Participants n=93 Participants	154 Participants n=4 Participants	398 Participants n=27 Participants	400 Participants n=483 Participants	1091 Participants n=36 Participants
Race/Ethnicity, Customized White	168 Participants n=93 Participants	178 Participants n=4 Participants	471 Participants n=27 Participants	481 Participants n=483 Participants	1298 Participants n=36 Participants
Race/Ethnicity, Customized Asian	28 Participants n=93 Participants	26 Participants n=4 Participants	71 Participants n=27 Participants	70 Participants n=483 Participants	195 Participants n=36 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	7 Participants n=27 Participants	1 Participants n=483 Participants	9 Participants n=36 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants
Race/Ethnicity, Customized Missing	1 Participants n=93 Participants	0 Participants n=4 Participants	18 Participants n=27 Participants	10 Participants n=483 Participants	29 Participants n=36 Participants

PRIMARY outcome

Timeframe: approximately 5 years

Population: ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo	NA months NA = DFS median and confidence interval were not determined because not enough events occurred at the analysis	NA months NA = DFS median and confidence interval were not determined because not enough events occurred at the analysis	—	—

SECONDARY outcome

Timeframe: approximately 8.5 years

Population: ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily

Overall survival is defined as the time from randomization until death due to any cause. For subjects who did not die, time to death was censored at the last date of known contact.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo	89.5 months NA = the last follow-up patient in this group died at the end of study, so the median survival was estimated (the survival curve crossed 50%). But the 95% CI was not estimable due to less than 50% events (death) occurring in pazopanib group.	NA months NA = the last follow-up patient in this group was censored at the end of study and less than 50% events (death) occurred, so both median and 95%CI were not estimable	—	—

SECONDARY outcome

Timeframe: yearly for 4 years

Population: ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
DFS Rates at Yearly Time Points With Pazopanib 600 mg Daily Initial Dose vs. Placebo DFS at 1 year	0.85 Proportion of participants Interval 0.81 to 0.88	0.76 Proportion of participants Interval 0.72 to 0.79	—	—
DFS Rates at Yearly Time Points With Pazopanib 600 mg Daily Initial Dose vs. Placebo DFS at 2 years	0.72 Proportion of participants Interval 0.67 to 0.75	0.68 Proportion of participants Interval 0.64 to 0.72	—	—
DFS Rates at Yearly Time Points With Pazopanib 600 mg Daily Initial Dose vs. Placebo DFS at 3 years	0.65 Proportion of participants Interval 0.61 to 0.7	0.64 Proportion of participants Interval 0.59 to 0.68	—	—

SECONDARY outcome

Timeframe: approximately 5 years

Population: Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=769 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=769 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
DFS With Pazopanib vs. Placebo	NA months NA = DFS median or confidence interval were not determined because not enough events occurred at the analysis.	NA months Interval 48.1 to NA = DFS median or upper limit of confidence interval were not determined because not enough events occurred at the analysis.	—	—

SECONDARY outcome

Timeframe: approximately 8.5 years

Population: Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.

Overall survival is defined as the time from randomization until death due to any cause. For subjects who do not die, time to death will be censored at the last date of known contact.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=769 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=769 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
OS With Pazopanib vs. Placebo	NA months NA = OS median or confidence interval were not determined because not enough events occurred at the analysis.	NA months NA = OS median or confidence interval were not determined because not enough events occurred at the analysis.	—	—

SECONDARY outcome

Timeframe: yearly for 4 years

Population: Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=769 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=769 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
DFS Rates at Yearly Time Points With Pazopanib vs. Placebo DFS at 1 year	0.85 Proportion of participants Interval 0.82 to 0.87	0.75 Proportion of participants Interval 0.72 to 0.78	—	—
DFS Rates at Yearly Time Points With Pazopanib vs. Placebo DFS at 2 years	0.72 Proportion of participants Interval 0.68 to 0.75	0.66 Proportion of participants Interval 0.63 to 0.7	—	—
DFS Rates at Yearly Time Points With Pazopanib vs. Placebo DFS at 3 years	0.65 Proportion of participants Interval 0.62 to 0.69	0.61 Proportion of participants Interval 0.58 to 0.65	—	—
DFS Rates at Yearly Time Points With Pazopanib vs. Placebo DFS at 4 years	0.62 Proportion of participants Interval 0.58 to 0.66	0.56 Proportion of participants Interval 0.51 to 0.61	—	—

SECONDARY outcome

Timeframe: approximately 5 years

Population: ITT 800 included all randomized subjects with a scheduled initial dose of 800 mg daily.

DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=198 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=205 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo	NA months NA = DFS median or confidence interval were not determined because not enough events occurred at the analysis.	48.1 months Interval 30.1 to NA = DFS median or upper limit confidence interval were not determined because not enough events occurred at the analysis.	—	—

SECONDARY outcome

Timeframe: approximately 8.5 years

Population: ITT 800 included all randomized subjects with a scheduled initial dose of 800 mg daily.

Overall survival is defined as the time from randomization until death due to any cause. For subjects who did not die, time to death was censored at the last date of known contact.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=198 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=205 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
OS With Pazopanib 800 mg Daily Initial Dose vs. Placebo	NA months NA = OS was not determined because not enough events occurred at the analysis.	NA months NA = OS was not determined because not enough events occurred at the analysis.	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Population: ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score 36M DFS FU	-0.14 scores on a scale Standard Error 0.454	-0.26 scores on a scale Standard Error 0.456	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score Week 52	-3.83 scores on a scale Standard Error 0.452	-0.43 scores on a scale Standard Error 0.459	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score 24M DFS FU	0.19 scores on a scale Standard Error 0.419	0.23 scores on a scale Standard Error 0.418	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score 48M DFS FU	-0.13 scores on a scale Standard Error 0.526	0.22 scores on a scale Standard Error 0.529	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score 54M DFS FU	0.09 scores on a scale Standard Error 0.653	0.26 scores on a scale Standard Error 0.635	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Population: ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative mean indicates a worsening of condition.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score Week 52	-2.06 scores on a scale Standard Error 0.278	-0.44 scores on a scale Standard Error 0.282	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score 24M DFS FU	-0.32 scores on a scale Standard Error 0.273	-0.20 scores on a scale Standard Error 0.273	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score 36M DFS FU	-0.61 scores on a scale Standard Error 0.291	-0.53 scores on a scale Standard Error 0.294	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score 48M DFS FU	-0.67 scores on a scale Standard Error 0.332	-0.46 scores on a scale Standard Error 0.336	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score 54M DFS FU	-0.21 scores on a scale Standard Error 0.449	-0.55 scores on a scale Standard Error 0.439	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU

Population: ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative mean indicates a worsening of condition.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score Week 52	0.01 scores on a scale Standard Error 0.054	0.09 scores on a scale Standard Error 0.055	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score 24M DFS FU	0.11 scores on a scale Standard Error 0.056	0.16 scores on a scale Standard Error 0.056	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score 36M DFS FU	0.13 scores on a scale Standard Error 0.059	0.12 scores on a scale Standard Error 0.059	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score 48M DFS FU	0.08 scores on a scale Standard Error 0.075	0.20 scores on a scale Standard Error 0.076	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score 54M DFS FU	0.04 scores on a scale Standard Error 0.090	0.24 scores on a scale Standard Error 0.087	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU

Population: ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score Week 52	-1.73 scores on a scale Standard Error 0.101	-0.34 scores on a scale Standard Error 0.103	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score 24M DFS FU	0.12 scores on a scale Standard Error 0.061	0.01 scores on a scale Standard Error 0.060	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score 36M DFS FU	0.05 scores on a scale Standard Error 0.067	-00.3 scores on a scale Standard Error 0.067	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score 48M DFS FU	-0.04 scores on a scale Standard Error 0.087	-0.01 scores on a scale Standard Error 0.088	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score 54M DFS FU	0.07 scores on a scale Standard Error 0.089	0.09 scores on a scale Standard Error 0.086	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU

Population: ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.

Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score Week 52	0.06 scores on a scale Standard Error 0.153	0.33 scores on a scale Standard Error 0.155	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score 24M DFS FU	0.39 scores on a scale Standard Error 0.168	0.32 scores on a scale Standard Error 0.168	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score 36M DFS FU	0.43 scores on a scale Standard Error 0.177	0.24 scores on a scale Standard Error 0.178	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score 48M DFS FU	0.51 scores on a scale Standard Error 0.219	0.42 scores on a scale Standard Error 0.222	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score 54M DFS FU	0.31 scores on a scale Standard Error 0.308	0.59 scores on a scale Standard Error 0.299	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Population: ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.

Health outcome and quality of life measured by EQ-5D thermometer (thermo) score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=571 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=564 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score Week 52 thermo. score	0.713 scores on a scale Standard Error 0.858	1.430 scores on a scale Standard Error 0.868	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score 24M DFS FU thermo. score	3.356 scores on a scale Standard Error 0.882	3.641 scores on a scale Standard Error 0.877	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score 36M DFS FU thermo. score	3.640 scores on a scale Standard Error 0.882	2.459 scores on a scale Standard Error 0.883	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score 48M DFS FU thermo. score	3.909 scores on a scale Standard Error 1.014	3.184 scores on a scale Standard Error 1.015	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score 54M DFS FU thermo. score	3.076 scores on a scale Standard Error 1.607	1.053 scores on a scale Standard Error 1.560	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score Week 52 UI score	-0.019 scores on a scale Standard Error 0.009	-0.001 scores on a scale Standard Error 0.009	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score 24M DFS FU UI score	-0.004 scores on a scale Standard Error 0.010	0.016 scores on a scale Standard Error 0.010	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score 36M DFS FU UI score	0.002 scores on a scale Standard Error 0.011	-0.008 scores on a scale Standard Error 0.011	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score 48M DFS FU UI score	-0.002 scores on a scale Standard Error 0.013	0.008 scores on a scale Standard Error 0.013	—	—
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score 54M DFS FU UI score	0.004 scores on a scale Standard Error 0.017	-0.013 scores on a scale Standard Error 0.017	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Population: Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=769 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=769 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score Week 52	-4.01 scores on a scale Standard Error 0.385	-0.47 scores on a scale Standard Error 0.388	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score 24M DFS FU	0.23 scores on a scale Standard Error 0.361	0.33 scores on a scale Standard Error 0.362	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score 36M DFS FU	0.16 scores on a scale Standard Error 0.385	-0.07 scores on a scale Standard Error 0.389	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score 48M DFS FU	0.47 scores on a scale Standard Error 0.421	0.39 scores on a scale Standard Error 0.427	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score 54M DFS FU	0.27 scores on a scale Standard Error 0.505	-0.14 scores on a scale Standard Error 0.509	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Population: Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative mean indicates a worsening of condition.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=769 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=769 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score 48M DFS FU	-0.25 scores on a scale Standard Error 0.270	-0.19 scores on a scale Standard Error 0.275	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score Week 52	-2.03 scores on a scale Standard Error 0.235	-0.51 scores on a scale Standard Error 0.237	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score 24M DFS FU	-0.24 scores on a scale Standard Error 0.232	-0.25 scores on a scale Standard Error 0.233	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score 36M DFS FU	-0.41 scores on a scale Standard Error 0.247	-0.45 scores on a scale Standard Error 0.250	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score 54M DFS FU	-0.23 scores on a scale Standard Error 0.329	-0.68 scores on a scale Standard Error 0.333	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Population: Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4).A negative mean indicates a worsening of condition.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=769 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=769 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-emotional (DRS-E) Domain Score Week 52	0.04 scores on a scale Standard Error 0.045	0.14 scores on a scale Standard Error 0.046	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-emotional (DRS-E) Domain Score 24M DFS FU	0.15 scores on a scale Standard Error 0.048	0.19 scores on a scale Standard Error 0.048	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-emotional (DRS-E) Domain Score 36M DFS FU	0.19 scores on a scale Standard Error 0.050	0.15 scores on a scale Standard Error 0.051	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-emotional (DRS-E) Domain Score 48M DFS FU	0.16 scores on a scale Standard Error 0.059	0.20 scores on a scale Standard Error 0.060	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-emotional (DRS-E) Domain Score 54M DFS FU	0.16 scores on a scale Standard Error 0.065	0.17 scores on a scale Standard Error 0.066	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Population: Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=769 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=769 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score Week 52	-1.86 scores on a scale Standard Error 0.089	-0.33 scores on a scale Standard Error 0.090	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score 24M DFS FU	0.12 scores on a scale Standard Error 0.052	0.04 scores on a scale Standard Error 0.052	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score 36M DFS FU	0.11 scores on a scale Standard Error 0.057	-0.02 scores on a scale Standard Error 0.058	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score 48M DFS FU	0.05 scores on a scale Standard Error 0.065	-0.00 scores on a scale Standard Error 0.066	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score 54M DFS FU	0.09 scores on a scale Standard Error 0.074	0.03 scores on a scale Standard Error 0.074	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Population: Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.

Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=769 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=769 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score Week 52	-0.08 scores on a scale Standard Error 0.134	0.30 scores on a scale Standard Error 0.136	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score 24M DFS FU	0.30 scores on a scale Standard Error 0.147	0.41 scores on a scale Standard Error 0.147	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score 36M DFS FU	0.3 scores on a scale Standard Error 0.151	0.29 scores on a scale Standard Error 0.153	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score 48M DFS FU	0.50 scores on a scale Standard Error 0.179	0.38 scores on a scale Standard Error 0.183	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score 54M DFS FU	0.39 scores on a scale Standard Error 0.206	0.44 scores on a scale Standard Error 0.208	—	—

SECONDARY outcome

Timeframe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Population: Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.

Health outcome and quality of life measured by using EQ-5D thermometer score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=769 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=769 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score 54M DFS FU thermos.	3.650 scores on a scale Standard Error 1.028	3.249 scores on a scale Standard Error 1.043	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score Week 52 thermo.	0.744 scores on a scale Standard Error 0.733	2.859 scores on a scale Standard Error 0.742	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score 24M DFS FU thermo.	4.043 scores on a scale Standard Error 0.741	4.296 scores on a scale Standard Error 0.743	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score 36M DFS FU thermo.	3.997 scores on a scale Standard Error 0.774	3.150 scores on a scale Standard Error 0.781	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score 48M DFS FU thermo.	4.683 scores on a scale Standard Error 0.863	4.552 scores on a scale Standard Error 0.877	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score Week 52 UI score	-0.023 scores on a scale Standard Error 0.008	0.003 scores on a scale Standard Error 0.008	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score 24M DFS FU UI score	0.001 scores on a scale Standard Error 0.008	0.017 scores on a scale Standard Error 0.008	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score 36M DFS FU UI score	0.004 scores on a scale Standard Error 0.009	-0.004 scores on a scale Standard Error 0.009	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score 48M DFS FU UI score	-0.004 scores on a scale Standard Error 0.010	0.010 scores on a scale Standard Error 0.010	—	—
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score 54M DFS FU UI score	-0.004 scores on a scale Standard Error 0.012	0.003 scores on a scale Standard Error 0.012	—	—

POST_HOC outcome

Timeframe: approx. 13 months, approx. 8.5 years

Population: Safety 800: subjects who received at least one dose of study treatment in the ITT 800 population Safety 600: subjects who received at least one dose of study treatment in the ITT 600 population

On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Deaths post treatment survival follow up were collected after the on-treatment period, up to approx. 8.5 years. Participants who had not died after study drug discontinuation were censored: 82% of participants in the ITT 600 population and 78% of participants in the ITT 800 population.

Outcome measures

Outcome measures
Measure	ITT Pazopanib 600 mg n=198 Participants Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=204 Participants Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	Safety Pazopanib 600 mg n=568 Participants Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.	Safety Placebo 600 mg n=558 Participants Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.
All Collected Deaths Total Deaths	43 participants	46 participants	102 participants	104 participants
All Collected Deaths On-Treatment Deaths	1 participants	0 participants	3 participants	0 participants
All Collected Deaths Deaths post-treatment survival follow-up	42 participants	46 participants	99 participants	104 participants

Adverse Events

ITT Pazopanib 800 mg

Serious events: 44 serious events

Other events: 194 other events

Deaths: 1 deaths

ITT Placebo 800 mg

Serious events: 14 serious events

Other events: 147 other events

Deaths: 0 deaths

I TT Pazopanib 600 mg

Serious events: 123 serious events

Other events: 541 other events

Deaths: 3 deaths

ITT Placebo 600 mg

Serious events: 54 serious events

Other events: 448 other events

Deaths: 0 deaths

ITT All - Pazopanib

Serious events: 167 serious events

Other events: 735 other events

Deaths: 4 deaths

ITT All - Placebo

Serious events: 68 serious events

Other events: 595 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ITT Pazopanib 800 mg n=198 participants at risk Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 800 mg n=204 participants at risk Placebo matching pazopanib 800 mg daily. Complete treatment is 12 months.	I TT Pazopanib 600 mg n=568 participants at risk Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=558 participants at risk Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	ITT All - Pazopanib n=766 participants at risk All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.	ITT All - Placebo n=762 participants at risk All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
Hepatobiliary disorders Cholecystitis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.54% 3/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.52% 4/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Blood and lymphatic system disorders Neutropenia	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.35% 2/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Acute coronary syndrome	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Acute myocardial infarction	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Angina pectoris	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.98% 2/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.39% 3/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Atrioventricular block second degree	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Bradycardia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Cardiomyopathy	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Coronary artery stenosis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Myocardial infarction	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Cardiac disorders Ventricular tachycardia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Endocrine disorders Basedow's disease	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Eye disorders Macular hole	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Eye disorders Retinal detachment	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.35% 2/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Eye disorders Retinal tear	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Eye disorders Visual impairment	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Abdominal pain	1.0% 2/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.39% 3/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Diarrhoea	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.53% 3/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.52% 4/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Large intestine perforation	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Pancreatitis	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.35% 2/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.39% 3/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.35% 2/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Vomiting	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
General disorders Chest pain	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
General disorders Pyrexia	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.98% 2/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Hepatobiliary disorders Bile duct stone	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Hepatobiliary disorders Biliary colic	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Hepatobiliary disorders Hepatic function abnormal	2.5% 5/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.53% 3/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.0% 8/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Hepatobiliary disorders Liver disorder	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Hepatobiliary disorders Liver injury	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Immune system disorders Hypersensitivity	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Immune system disorders Lung transplant rejection	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Abdominal wall abscess	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Anal abscess	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Appendiceal abscess	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Bacterial sepsis	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Bronchitis	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Bronchitis viral	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Cystitis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Diabetic gangrene	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Erysipelas	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Gastroenteritis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.54% 3/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.39% 3/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Gastroenteritis salmonella	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Infected skin ulcer	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Peritonsillar abscess	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Pneumonia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Pulmonary tuberculosis	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Respiratory tract infection	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Sepsis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Superinfection bacterial	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Urinary tract infection	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Urosepsis	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Viral infection	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Alanine aminotransferase increased	7.6% 15/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.0% 51/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.6% 66/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Aspartate aminotransferase increased	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.1% 12/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.7% 13/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Bilirubin conjugated increased	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Blood bilirubin increased	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.53% 3/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.39% 3/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Blood glucose increased	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Hepatic enzyme increased	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.70% 4/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.52% 4/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations International normalised ratio increased	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Lipase increased	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Pancreatic enzymes increased	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Transaminases increased	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.53% 3/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.39% 3/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Metabolism and nutrition disorders Dehydration	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.53% 3/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.52% 4/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Metabolism and nutrition disorders Hyponatraemia	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Biliary neoplasm	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour thrombosis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Brain hypoxia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Cerebral haemorrhage	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.35% 2/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Cerebral ischaemia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Dizziness	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Presyncope	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Seizure	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Syncope	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.35% 2/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Transient ischaemic attack	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Psychiatric disorders Depression	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Psychiatric disorders Panic disorder	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Psychiatric disorders Suicide attempt	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Nephrolithiasis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Proteinuria	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Renal colic	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Renal failure	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.35% 2/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Ureterolithiasis	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Reproductive system and breast disorders Menorrhagia	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.35% 2/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.54% 3/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.52% 4/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.35% 2/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Vascular disorders Deep vein thrombosis	1.5% 3/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.52% 4/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Vascular disorders Hypertension	1.0% 2/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.39% 3/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Vascular disorders Hypertensive crisis	0.51% 1/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Vascular disorders Hypotension	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Vascular disorders Hypovolaemic shock	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Vascular disorders Thrombophlebitis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Vascular disorders Venous thrombosis	0.00% 0/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.18% 1/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.13% 1/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.

Other adverse events

Other adverse events
Measure	ITT Pazopanib 800 mg n=198 participants at risk Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 800 mg n=204 participants at risk Placebo matching pazopanib 800 mg daily. Complete treatment is 12 months.	I TT Pazopanib 600 mg n=568 participants at risk Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.	ITT Placebo 600 mg n=558 participants at risk Placebo matching pazopanib 600 mg daily. Complete treatment is 12 months.	ITT All - Pazopanib n=766 participants at risk All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.	ITT All - Placebo n=762 participants at risk All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
Blood and lymphatic system disorders Neutropenia	6.1% 12/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.00% 0/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.4% 25/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.8% 37/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.26% 2/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Blood and lymphatic system disorders Thrombocytopenia	6.1% 12/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.9% 22/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.1% 6/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.4% 34/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.92% 7/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Endocrine disorders Hypothyroidism	12.1% 24/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.98% 2/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.7% 55/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.72% 4/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	10.3% 79/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.79% 6/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Abdominal pain	13.6% 27/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	11.8% 24/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	15.0% 85/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.2% 46/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	14.6% 112/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.2% 70/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Abdominal pain upper	9.1% 18/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.5% 5/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	10.2% 58/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.2% 18/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.9% 76/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.0% 23/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Constipation	8.6% 17/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.3% 17/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.9% 28/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.8% 38/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.9% 45/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	7.2% 55/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Diarrhoea	65.2% 129/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	23.5% 48/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	63.6% 361/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	24.9% 139/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	64.0% 490/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	24.5% 187/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Dyspepsia	8.6% 17/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.4% 13/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	7.6% 43/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.0% 17/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	7.8% 60/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.9% 30/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Flatulence	4.0% 8/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.9% 6/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.6% 32/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.2% 18/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.2% 40/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.1% 24/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Nausea	44.9% 89/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	13.7% 28/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	39.8% 226/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	15.9% 89/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	41.1% 315/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	15.4% 117/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Stomatitis	11.6% 23/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.9% 10/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.7% 55/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.1% 23/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	10.2% 78/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.3% 33/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Gastrointestinal disorders Vomiting	18.7% 37/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.9% 8/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	16.7% 95/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.8% 21/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	17.2% 132/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.8% 29/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
General disorders Asthenia	12.1% 24/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.9% 12/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	13.9% 79/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.5% 53/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	13.4% 103/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.5% 65/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
General disorders Fatigue	37.4% 74/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	26.0% 53/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	39.1% 222/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	25.8% 144/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	38.6% 296/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	25.9% 197/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
General disorders Mucosal inflammation	10.6% 21/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.5% 5/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.1% 46/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.0% 17/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.7% 67/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.9% 22/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
General disorders Oedema peripheral	6.1% 12/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.9% 10/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.0% 17/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.2% 29/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.8% 29/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.1% 39/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
General disorders Pyrexia	6.6% 13/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.4% 7/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.7% 21/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.9% 22/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.4% 34/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.8% 29/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Nasopharyngitis	6.6% 13/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.9% 12/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.8% 27/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	7.2% 40/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.2% 40/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.8% 52/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Infections and infestations Upper respiratory tract infection	5.6% 11/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.4% 7/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.1% 12/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.8% 21/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.0% 23/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.7% 28/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Alanine aminotransferase increased	25.8% 51/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.4% 11/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	25.7% 146/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.7% 26/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	25.7% 197/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.9% 37/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Aspartate aminotransferase increased	24.2% 48/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.5% 5/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	22.7% 129/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.9% 22/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	23.1% 177/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.5% 27/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Blood bilirubin increased	4.0% 8/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.5% 5/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.6% 32/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.1% 6/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.2% 40/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.4% 11/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Blood creatinine increased	7.1% 14/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.9% 14/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.1% 29/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.7% 32/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.6% 43/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.0% 46/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Platelet count decreased	5.1% 10/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.49% 1/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.6% 32/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.3% 7/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.5% 42/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.0% 8/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Investigations Weight decreased	5.1% 10/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.98% 2/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.8% 33/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.3% 7/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.6% 43/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.2% 9/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Metabolism and nutrition disorders Decreased appetite	21.2% 42/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.4% 11/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	19.7% 112/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.9% 22/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	20.1% 154/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.3% 33/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 18/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.4% 13/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.3% 47/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	12.2% 68/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.5% 65/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	10.6% 81/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Back pain	14.6% 29/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	7.4% 15/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.3% 53/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	14.0% 78/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	10.7% 82/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	12.2% 93/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	6.6% 13/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.9% 10/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.6% 26/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.0% 11/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.1% 39/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.8% 21/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Myalgia	8.1% 16/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.9% 8/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.9% 39/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.7% 32/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	7.2% 55/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.2% 40/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 22/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.9% 12/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	7.4% 42/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.4% 30/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.4% 64/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.5% 42/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Dizziness	13.1% 26/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.3% 17/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.8% 50/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.3% 52/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.9% 76/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.1% 69/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Dysgeusia	21.7% 43/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.5% 5/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	30.1% 171/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.7% 15/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	27.9% 214/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.6% 20/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Nervous system disorders Headache	29.3% 58/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	17.2% 35/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	24.5% 139/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	14.0% 78/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	25.7% 197/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	14.8% 113/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Psychiatric disorders Insomnia	5.1% 10/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.9% 8/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.1% 29/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.0% 28/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.1% 39/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.7% 36/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Renal and urinary disorders Proteinuria	7.1% 14/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.5% 5/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.2% 24/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.36% 2/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.0% 38/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.92% 7/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Cough	7.6% 15/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.9% 12/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.0% 51/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.3% 52/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.6% 66/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.4% 64/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.1% 14/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	0.98% 2/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.7% 55/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.8% 10/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	9.0% 69/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	1.6% 12/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.6% 17/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.9% 10/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.2% 35/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.7% 26/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.8% 52/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.7% 36/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.1% 16/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.5% 5/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.3% 47/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.0% 11/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.2% 63/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.1% 16/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Skin and subcutaneous tissue disorders Alopecia	13.1% 26/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	2.9% 6/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	11.3% 64/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.4% 19/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	11.7% 90/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.3% 25/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Skin and subcutaneous tissue disorders Dry skin	7.1% 14/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.4% 9/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.7% 38/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.7% 32/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.8% 52/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.4% 41/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Skin and subcutaneous tissue disorders Hair colour changes	45.5% 90/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.4% 9/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	40.8% 232/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	5.0% 28/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	42.0% 322/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.9% 37/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	21.2% 42/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	3.9% 8/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	18.1% 103/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.3% 24/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	18.9% 145/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.2% 32/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Skin and subcutaneous tissue disorders Pruritus	6.1% 12/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	8.3% 17/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.4% 25/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	7.3% 41/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	4.8% 37/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	7.6% 58/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Skin and subcutaneous tissue disorders Rash	12.1% 24/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.9% 14/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	11.1% 63/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.5% 36/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	11.4% 87/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	6.6% 50/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
Vascular disorders Hypertension	54.5% 108/198 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	14.7% 30/204 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	51.8% 294/568 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	19.2% 107/558 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	52.5% 402/766 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.	18.0% 137/762 • On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER