Trial Outcomes & Findings for This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer (NCT NCT03099174)

Last Updated: 2025-06-24

Results Overview

MTD during the MTD evaluation period (the first 28 day cycle). The MTD is defined as the highest dose with \<25% risk of the true Dose limiting toxicity (DLT) rate \>33%. DLT: adverse event or laboratory abnormality which 1) is related, probably related or possibly related to study drug and 2) meets any of the following criteria, unless that toxicity can be attributed to cancer progression or to identified etiology: CTCAE grade (Gr). 3+ hyperglycaemia (\>48 hours), Gr. 4 hyperglycaemia, hematologic toxicity (\>5 days), Gr. 3+ pneumonitis, febrile neutropenia, thrombocytopenia (Gr. 4 any duration, Gr. 3 w/ bleeding), AST/ALT \> 5x ULN or \> (baseline + 4x ULN), Gr. 3+ diarrhoea, nausea, vomiting (\>2 days), skin rash, fatigue/asthenia (\>7 days), Gr. 3-4 hyperlipidaemia (\>2 weeks), Any AE causing 2-week treatment interruption, non-hematologic toxicities Gr. 3+ (except alopecia, infusion-related reaction), Any significant drug related toxicity qualified as DLT.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

133 participants

Primary outcome timeframe

The first treatment cycle, up to 28 days.

Results posted on

2025-06-24

Participant Flow

This study was an open label, phase Ib, dose-escalation study followed by expansion cohorts.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort E: Xentuzumab 1000 mg & 150 mg Abemaciclib Patients with non-small cell lung cancer (NSCLC) received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort F: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D1: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D2: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
Overall Study STARTED	6	7	7	8	26	15	33	31
Overall Study COMPLETED	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	6	7	7	8	26	15	33	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort E: Xentuzumab 1000 mg & 150 mg Abemaciclib Patients with non-small cell lung cancer (NSCLC) received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort F: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D1: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D2: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
Overall Study Withdrawal by Subject	0	0	1	0	2	2	1	4
Overall Study Adverse Event	0	1	1	2	5	3	6	4
Overall Study Other than listed	6	6	5	6	19	10	26	23

Baseline Characteristics

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=6 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=7 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=7 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=8 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort E: Xentuzumab 1000 mg & 150 mg Abemaciclib n=26 Participants Patients with non-small cell lung cancer (NSCLC) received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort F: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=15 Participants Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D1: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=33 Participants Patients with visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D2: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=31 Participants Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Total n=133 Participants Total of all reporting groups
Age, Continuous	60.5 years STANDARD_DEVIATION 3.6 • n=5 Participants	53.6 years STANDARD_DEVIATION 10.3 • n=7 Participants	60.1 years STANDARD_DEVIATION 12.5 • n=5 Participants	51.9 years STANDARD_DEVIATION 11.4 • n=4 Participants	64.4 years STANDARD_DEVIATION 7.0 • n=21 Participants	56.7 years STANDARD_DEVIATION 12.0 • n=8 Participants	58.3 years STANDARD_DEVIATION 10.2 • n=8 Participants	53.7 years STANDARD_DEVIATION 10.7 • n=24 Participants	57.8 years STANDARD_DEVIATION 10.6 • n=42 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	15 Participants n=8 Participants	33 Participants n=8 Participants	31 Participants n=24 Participants	114 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	19 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	22 Participants n=21 Participants	8 Participants n=8 Participants	30 Participants n=8 Participants	27 Participants n=24 Participants	110 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	20 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=8 Participants	9 Participants n=8 Participants	7 Participants n=24 Participants	27 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	17 Participants n=21 Participants	8 Participants n=8 Participants	21 Participants n=8 Participants	21 Participants n=24 Participants	83 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	22 Participants n=42 Participants

PRIMARY outcome

Timeframe: The first treatment cycle, up to 28 days.

Population: The MTD set defines the set of patients in the dose-finding cohorts (cohorts A,B,C and D) of the trial that are fully evaluable for determination of the MTD in the first treatment course.

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=6 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=6 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=6 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=6 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohort A, B, C & D] Maximum Tolerated Dose (MTD) of Xentuzumab	1000 milligram	1000 milligram	1000 milligram	1000 milligram

PRIMARY outcome

Timeframe: The first treatment cycle, up to 28 days.

Population: The MTD set defines the set of patients in the dose-finding cohorts (cohorts A,B,C and D) of the trial that are fully evaluable for determination of the MTD in the first treatment course.

Number of patients with Dose limiting toxicities in the MTD evaluation period. Dose limiting toxicity (DLT): adverse event or laboratory abnormality which 1) is related, probably related or possibly related to study drug and 2) meets any of the following criteria, unless that toxicity can be attributed to cancer progression or to identified etiology: CTCAE grade (Gr). 3+ hyperglycaemia (\>48 hours), Gr. 4 hyperglycaemia, hematologic toxicity (\>5 days), Gr. 3+ pneumonitis, febrile neutropenia, thrombocytopenia (Gr. 4 any duration, Gr. 3 w/ bleeding), AST/ALT \> 5x ULN or \> (baseline + 4x ULN), Gr. 3+ diarrhoea, nausea, vomiting (\>2 days), skin rash, fatigue/asthenia (\>7 days), Gr. 3-4 hyperlipidaemia (\>2 weeks), Any AE causing 2-week treatment interruption, non-hematologic toxicities Gr. 3+ (except alopecia, infusion-related reaction), Any significant drug related toxicity qualified as DLT.

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=6 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=6 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=6 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=6 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohort A, B, C & D] Number of Patients With DLTs in the MTD Evaluation Period	2 Participants	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 26.5 months

Population: All patients in cohort E who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).

Objective response (OR) defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 from date of first treatment administration (including run-in for cohort E) until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 millimeter (mm)). For non-target lesions: disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10mm short axis). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=26 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohort E] Number of Patients With Objective Response (OR)	1 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to 18 months.

Population: All patients in cohort D1 and D2 who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).

Progression free survival (PFS) rate at 18 month defined as the rate of absence of disease progression or death at the 18th month of treatment, where progression is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions: Unequivocal progression of existing non-target lesions (Note: the appearance of one or more new lesions is also considered progression). Reported is the progression free survival rate at 18 months, based on a Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=33 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=31 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohorts D1 and D2] Progression Free Survival (PFS) at 18 Months	0.4143 Probability of Survival at 18 months	0.7854 Probability of Survival at 18 months	—	—

PRIMARY outcome

Timeframe: Up to 18.5 months.

Population: All patients in cohort F who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).

Disease control (DC) defined as best overall response of complete response (CR) or partial response (PR) or confirmed stable disease (SD) (lasting for at least 24 weeks) or Non-CR/ Non-PD (lasting for at least 24 weeks) where best overall response is defined according to RECIST version 1.1 from first treatment administration until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=15 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohort F] Disease Control (DC)	6 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 35.2 months.

Population: All patients in cohort Cohorts E, D1 and D2 who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=26 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=33 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=31 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohorts E, D1 and D2] Disease Control (DC)	12 Participants	23 Participants	24 Participants	—

SECONDARY outcome

Timeframe: Up to 21.9 months.

Population: All patients in cohort Cohorts E, F, D1 and D2 who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period) and who had an objective response.

Time to objective response defined as the time from first treatment administration until first documented complete response (CR) or partial response (PR).

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=1 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=1 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=20 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=6 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohorts E, F, D1 and D2] Time to Objective Response	1.94 Months Interval 1.94 to 1.94	9.36 Months Interval 9.36 to 9.36	3.52 Months Interval 2.66 to 6.36	5.45 Months Interval 1.71 to 14.23

SECONDARY outcome

Timeframe: Up to 27.2 months.

Duration of objective response defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response.

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=1 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=1 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=20 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=6 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohorts E, F, D1 and D2] Duration of Objective Response	5.78 Months Interval 5.78 to 5.78	4.63 Months Interval 4.63 to 4.63	11.12 Months Interval 6.47 to 23.59	17.54 Months Interval 11.17 to 23.95

SECONDARY outcome

Timeframe: Up to 33.1 months.

Duration of disease control defined as the time from first treatment administration until the earliest of disease progression or death, among patients with disease control.

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=12 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=6 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=23 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=24 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohorts E, F, D1 and D2] Duration of Disease Control	5.77 Months Interval 2.68 to 6.85	12.42 Months Interval 9.23 to 13.63	14.95 Months Interval 10.87 to 24.67	22.01 Months Interval 18.69 to 27.55

SECONDARY outcome

Timeframe: Up to 33 months.

Progression-free survival (PFS) defined as the time from first treatment administration until tumour progression according to RECIST 1.1 or death from any cause, whichever occurs earlier. Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions: Unequivocal progression of existing non-target lesions (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=26 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=15 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=33 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=31 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohorts E, F, D1 and D2] Progression-free Survival (PFS)	2.1 Months Interval 1.2 to 5.8	NA Months Interval 3.4 to Not enough patients with events.	13.6 Months Interval 4.5 to 30.2	33.1 Months Interval 18.3 to 33.1

SECONDARY outcome

Timeframe: Up to 35.2 months.

Population: All patients in cohort Cohorts F, D1 and D2 who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).

Objective response (OR) defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 from date of first treatment administration until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 millimeter (mm)). For non-target lesions: disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10mm short axis). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=15 Participants Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=33 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=31 Participants Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
[Cohorts D1, D2 and F] Objective Response (OR)	1 Participants	20 Participants	6 Participants	—

Adverse Events

Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib

Serious events: 0 serious events

Other events: 6 other events

Deaths: 2 deaths

Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole

Serious events: 4 serious events

Other events: 7 other events

Deaths: 2 deaths

Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole

Serious events: 4 serious events

Other events: 7 other events

Deaths: 2 deaths

Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort E: Xentuzumab 1000 mg & 150 mg Abemaciclib

Serious events: 13 serious events

Other events: 26 other events

Deaths: 13 deaths

Cohort F: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant

Serious events: 4 serious events

Other events: 15 other events

Deaths: 1 deaths

Cohort D1: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant

Serious events: 11 serious events

Other events: 33 other events

Deaths: 5 deaths

Cohort D2: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant

Serious events: 16 serious events

Other events: 31 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=6 participants at risk Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=7 participants at risk Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=7 participants at risk Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=8 participants at risk Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort E: Xentuzumab 1000 mg & 150 mg Abemaciclib n=26 participants at risk Patients with non-small cell lung cancer (NSCLC) received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort F: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=15 participants at risk Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D1: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=33 participants at risk Patients with visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D2: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=31 participants at risk Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Cardiac disorders Acute myocardial infarction	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Cardiac disorders Cardiac tamponade	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Cardiac disorders Myocardial infarction	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Cardiac disorders Tachycardia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Haematemesis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Nausea	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Pancreatitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Subileus	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Vomiting	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Asthenia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders General physical health deterioration	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Generalised oedema	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Implant site dehiscence	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Malaise	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Pyrexia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Hepatobiliary disorders Cholelithiasis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Bacteraemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations COVID-19 pneumonia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Chronic sinusitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Influenza	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Peritonitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Pneumonia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Pneumonia bacterial	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Respiratory syncytial virus infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Urinary tract infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Alanine aminotransferase increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood creatine phosphokinase increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood creatinine increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Cerebrovascular accident	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Haemorrhagic stroke	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Nervous system disorder	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Psychomotor hyperactivity	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Somnolence	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Spinal cord compression	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Confusional state	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Depression	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Suicide attempt	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Renal and urinary disorders Nephrolithiasis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Dry gangrene	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Embolism	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Jugular vein thrombosis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).

Other adverse events

Other adverse events
Measure	Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib n=6 participants at risk Patients with solid tumours received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole n=7 participants at risk Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 2.5 mg Letrozole (once daily film-coated tablet).	Cohort C: Xentuzumab 1000 mg & 150 mg Abemaciclib & 1 mg Anastrozole n=7 participants at risk Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 1 mg Anastrozole (once daily film-coated tablet).	Cohort D: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=8 participants at risk Patients with Hormone receptor+ (HR+) Human epidermal growth factor receptor 2 (HER2-) breast cancer received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort E: Xentuzumab 1000 mg & 150 mg Abemaciclib n=26 participants at risk Patients with non-small cell lung cancer (NSCLC) received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal.	Cohort F: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=15 participants at risk Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D1: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=33 participants at risk Patients with visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).	Cohort D2: Xentuzumab 1000 mg & 150 mg Abemaciclib & 500 mg Fulvestrant n=31 participants at risk Patients with non-visceral disease received 1000 milligram (mg) Xentuzumab (weekly 10 mg/milliliter intravenous infusion) and 150 mg Abemaciclib (every 12 hours three 50 mg film coated tablets) in a 28-day cycle until disease progression, intolerability of the study medication, or consent withdrawal. Combined with a background therapy of 500 mg Fulvestrant (Faslodex®) (once a month intramuscular injection, with an additional 500 mg dose given two weeks after the first dose).
Investigations Blood creatine phosphokinase MB increased	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood creatine phosphokinase increased	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.9% 4/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood creatinine increased	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.9% 3/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	37.5% 3/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	30.8% 8/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	24.2% 8/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.8% 8/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.9% 4/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood cholesterol increased	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Blood and lymphatic system disorders Anaemia	50.0% 3/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	100.0% 7/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	50.0% 4/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	38.5% 10/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	26.7% 4/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	45.5% 15/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	48.4% 15/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	85.7% 6/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	71.4% 5/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	50.0% 4/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	26.9% 7/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	33.3% 5/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	24.2% 8/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	32.3% 10/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Blood and lymphatic system disorders Thrombocytopenia	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.9% 3/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	23.1% 6/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	20.0% 3/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Cardiac disorders Bundle branch block left	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Cardiac disorders Conduction disorder	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Cardiac disorders Palpitations	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.9% 4/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Cardiac disorders Tachycardia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Ear and labyrinth disorders Hypoacusis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Ear and labyrinth disorders Tinnitus	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Ear and labyrinth disorders Vertigo	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Conjunctival haemorrhage	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Dry eye	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Eye haematoma	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Eye irritation	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Eye pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Eye pruritus	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Lacrimation increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.9% 4/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Photopsia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Vision blurred	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Visual impairment	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Eye disorders Xerophthalmia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Abdominal pain	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	71.4% 5/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.9% 3/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	37.5% 3/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	11.5% 3/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	46.7% 7/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	27.3% 9/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	35.5% 11/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.9% 3/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.9% 3/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	18.2% 6/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	19.4% 6/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Anal haemorrhage	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Anorectal discomfort	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Aphthous ulcer	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Ascites	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Constipation	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	11.5% 3/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	30.3% 10/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	29.0% 9/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Dental caries	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Diarrhoea	100.0% 6/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	100.0% 7/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	85.7% 6/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	100.0% 8/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	61.5% 16/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	93.3% 14/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	90.9% 30/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	93.5% 29/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.9% 4/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	15.2% 5/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Dysphagia	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Flatulence	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Gastritis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	15.4% 4/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	20.0% 3/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Mouth ulceration	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Nausea	50.0% 3/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	75.0% 6/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	61.5% 16/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	26.7% 4/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	66.7% 22/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	67.7% 21/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Odynophagia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Oesophagitis ulcerative	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Periodontal disease	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Retching	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	18.2% 6/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.9% 4/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Teeth brittle	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Toothache	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Gastrointestinal disorders Vomiting	66.7% 4/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	37.5% 3/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.3% 11/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	26.7% 4/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	27.3% 9/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	48.4% 15/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Asthenia	50.0% 3/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	71.4% 5/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	71.4% 5/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	62.5% 5/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	23.1% 6/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	60.0% 9/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	36.4% 12/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	32.3% 10/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Chest pain	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	11.5% 3/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Chills	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Fatigue	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	19.2% 5/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	35.5% 11/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Feeling abnormal	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Gait inability	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Illness	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Influenza like illness	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Injection site discomfort	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Injection site pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	37.5% 3/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Injection site pruritus	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Injection site reaction	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Malaise	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.9% 4/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Mucosal inflammation	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Nodule	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Oedema peripheral	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	15.2% 5/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Performance status decreased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Peripheral swelling	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Pyrexia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	15.2% 5/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	19.4% 6/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Swelling	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Vaccination site joint pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Vaccination site pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
General disorders Xerosis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Hepatobiliary disorders Cholelithiasis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	20.0% 3/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Hepatobiliary disorders Hepatomegaly	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Immune system disorders Contrast media allergy	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Immune system disorders Hypersensitivity	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Immune system disorders Seasonal allergy	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Bronchitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations COVID-19	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	20.0% 3/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Cellulitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Conjunctivitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Cystitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Dermatophytosis of nail	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Escherichia urinary tract infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Gastroenteritis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Gingivitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Herpes virus infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Influenza	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.9% 4/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Nasopharyngitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	50.0% 4/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Oral candidiasis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Oral herpes	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Paronychia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Pharyngitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Respiratory tract infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Rhinitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Sinusitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Skin infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Staphylococcal infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Tooth infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Urinary tract infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	20.0% 3/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	18.2% 6/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	19.4% 6/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Infections and infestations Viral infection	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	11.5% 3/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Head injury	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Limb injury	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Injury, poisoning and procedural complications Urostomy complication	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Activated partial thromboplastin time prolonged	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Alanine aminotransferase increased	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	11.5% 3/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	21.2% 7/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	22.6% 7/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Aspartate aminotransferase increased	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	85.7% 6/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	15.4% 4/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	26.7% 4/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	24.2% 8/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	22.6% 7/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Basophil count decreased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood albumin decreased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood bilirubin increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood glucose increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood phosphorus decreased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood potassium decreased	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood triglycerides increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood urea increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood uric acid increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Blood urine present	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Electrocardiogram PR shortened	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Electrocardiogram QT prolonged	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Gamma-glutamyltransferase increased	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	21.2% 7/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Glomerular filtration rate decreased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Glomerular filtration rate increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Glycosylated haemoglobin increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Haemoglobin decreased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations International normalised ratio increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Lymphocyte count decreased	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	11.5% 3/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	15.2% 5/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Neutrophil count decreased	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	15.4% 4/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	51.5% 17/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	51.6% 16/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Platelet count decreased	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.9% 3/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	34.6% 9/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	30.3% 10/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	41.9% 13/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Protein total decreased	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Transaminases increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Weight decreased	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	15.4% 4/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	19.4% 6/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations Weight increased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Investigations White blood cell count decreased	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	30.8% 8/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	24.2% 8/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	22.6% 7/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Decreased appetite	66.7% 4/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.9% 3/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	37.5% 3/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.3% 11/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	46.7% 7/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	36.4% 12/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	32.3% 10/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	19.2% 5/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Folate deficiency	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypoalbuminaemia	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	11.5% 3/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	19.4% 6/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	42.9% 3/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	57.1% 4/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	11.5% 3/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	20.0% 3/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	24.2% 8/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	41.9% 13/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	18.2% 6/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	32.3% 10/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	37.5% 3/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	26.7% 4/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	36.4% 12/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	19.4% 6/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	20.0% 3/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	24.2% 8/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	22.6% 7/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	37.5% 3/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	26.7% 4/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Ataxia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Dizziness	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	24.2% 8/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	22.6% 7/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Dysgeusia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	18.2% 6/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Headache	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	37.5% 3/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	53.3% 8/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	36.4% 12/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	48.4% 15/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Hypoaesthesia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Hypogeusia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Memory impairment	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Migraine	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Nervous system disorder	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Occipital neuralgia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Paraesthesia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Parosmia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Somnolence	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Syncope	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Tremor	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Nervous system disorders Trigeminal neuralgia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Anxiety	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Apathy	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Confusional state	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Depressed mood	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Depression	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Disorientation	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Dyssomnia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Skin toxicity	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Insomnia	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	18.2% 6/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	22.6% 7/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Mood swings	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Psychiatric disorders Sleep disorder	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Renal and urinary disorders Bladder pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Renal and urinary disorders Dysuria	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Renal and urinary disorders Haematuria	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Renal and urinary disorders Hypertonic bladder	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Renal and urinary disorders Micturition urgency	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Renal and urinary disorders Pollakiuria	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Renal and urinary disorders Renal failure	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Reproductive system and breast disorders Breast pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Reproductive system and breast disorders Pelvic pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Reproductive system and breast disorders Vaginal discharge	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Reproductive system and breast disorders Vulvovaginal inflammation	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Cough	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	50.0% 4/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	21.2% 7/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	22.6% 7/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	11.5% 3/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.9% 4/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Dermatitis acneiform	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	25.0% 2/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Erythrosis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Melanoderma	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.1% 2/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.2% 1/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Papule	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Pruritus	33.3% 2/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	7.7% 2/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	24.2% 8/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	16.1% 5/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	28.6% 2/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	37.5% 3/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	15.4% 4/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	20.0% 3/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	22.6% 7/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.0% 1/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Skin and subcutaneous tissue disorders Skin lesion	16.7% 1/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Axillary vein thrombosis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.7% 1/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Flushing	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Hot flush	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	20.0% 3/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.1% 4/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.7% 3/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Hypertension	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	13.3% 2/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	9.1% 3/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Hypotension	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	6.5% 2/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Lymphoedema	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Phlebitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Thrombophlebitis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	12.5% 1/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).
Vascular disorders Thrombosis	0.00% 0/6 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	14.3% 1/7 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/8 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	3.8% 1/26 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/15 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/33 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).	0.00% 0/31 • Up to approximately 35.5 months. Treated set (TS): all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (including run-in period).

Additional Information

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Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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