Trial Outcomes & Findings for Trial to Determine MTD of BI 836845 Administered Intravenously Once Every Three Weeks in Patients With Advanced Solid Tumours and Later a Weekly Dosing Schedule in Selected Tumour Types (NCT NCT01317420)

Last Updated: 2025-07-11

Results Overview

To determine the MTD or relevant biological dose (RBD) of BI 836845 during the first treatment course of the dose escalation phase. The MTD was defined as the highest dose level of BI 836845 below the maximum dose administered at which no more than 1 out of 6 patients experienced a drug-related DLT during the first course of treatment. Starting dose of 10 mg BI 836845, administered once every 3 weeks. Dose levels evaluated were: 10 mg, 20 mg, 40 mg, 80 mg, 160 mg, 320 mg, 640 mg, 1280 mg, 1800 mg, 2400 mg, and 3600 mg. In the absence of the MTD, the RBD, where a plateau in total Insulin-like growth factor 1 (IGF-1) level and total neutralisation of IGF activity is predicted, is reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

64 participants

Primary outcome timeframe

During the first course of treatment, up to 21 days

Results posted on

2025-07-11

Participant Flow

Open label, uncontrolled, dose escalation, 3+3 design, and multicenter study in two parts. Part 1: dose escalation in patients with advanced solid tumours to determine the MTD or RBD. Part 2: expansion part at the RBD in patients with selected tumour types more likely to benefit from BI 836845 (Cohort 1- Ewing's family of tumours or PNET; Cohort 2 - biopsiable solid tumours) in order to investigate safety and PK/pharmacodynamics.

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	BI 836845 10 mg Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 20 mg Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.
Overall Study STARTED	3	3	3	3	3	3	3	3	3	3	3	11	20
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	3	3	3	3	3	3	3	3	3	11	20

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 836845 10 mg Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 20 mg Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.
Overall Study Progressive disease according to RECIST	2	3	3	3	3	3	3	3	3	2	3	11	16
Overall Study Other adverse event	1	0	0	0	0	0	0	0	0	0	0	0	2
Overall Study Non-compliant with protocol	0	0	0	0	0	0	0	0	0	0	0	0	1
Overall Study Refused to cont. taking trial medication	0	0	0	0	0	0	0	0	0	0	0	0	1
Overall Study Reason other than those specified	0	0	0	0	0	0	0	0	0	1	0	0	0

Baseline Characteristics

Trial to Determine MTD of BI 836845 Administered Intravenously Once Every Three Weeks in Patients With Advanced Solid Tumours and Later a Weekly Dosing Schedule in Selected Tumour Types

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 836845 10 mg n=3 Participants Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 Participants Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 Participants Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 Participants Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 Participants Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 Participants Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 Participants Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 Participants Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=11 Participants Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=20 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Total n=64 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 16.3 • n=5 Participants	55.7 years STANDARD_DEVIATION 20.6 • n=7 Participants	56.0 years STANDARD_DEVIATION 11.1 • n=5 Participants	39.0 years STANDARD_DEVIATION 17.4 • n=4 Participants	63.0 years STANDARD_DEVIATION 14.4 • n=21 Participants	43.0 years STANDARD_DEVIATION 17.3 • n=8 Participants	51.0 years STANDARD_DEVIATION 20.0 • n=8 Participants	46.3 years STANDARD_DEVIATION 14.6 • n=24 Participants	64.0 years STANDARD_DEVIATION 1.0 • n=42 Participants	66.3 years STANDARD_DEVIATION 12.5 • n=42 Participants	63.7 years STANDARD_DEVIATION 8.1 • n=42 Participants	29.7 years STANDARD_DEVIATION 9.2 • n=42 Participants	60.3 years STANDARD_DEVIATION 10.7 • n=36 Participants	52.5 years STANDARD_DEVIATION 16.8 • n=36 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	8 Participants n=36 Participants	24 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	8 Participants n=42 Participants	12 Participants n=36 Participants	40 Participants n=36 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	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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	11 Participants n=42 Participants	20 Participants n=36 Participants	64 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 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	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 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	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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	11 Participants n=42 Participants	20 Participants n=36 Participants	62 Participants n=36 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants

PRIMARY outcome

Timeframe: During the first course of treatment, up to 21 days

Population: Treated set (TS) restricted to part 1 - dose escalation phase: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment in the dose escalation phase.

Outcome measures

Outcome measures
Measure	BI 836845 n=33 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Maximum Tolerated Dose (MTD) or Relevant Biological Dose (RBD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase	1000 mg	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: During the first course of treatment, up to 21 days

DLTs defined as drug related: CTCAE Grade 4 neutropenia lasting ≥7 days; febrile neutropenia and/or documented infection with Absolute Neutrophil Count \<1.0x109/L; Grade 4 thrombocytopaenia or Grade 3 associated with bleeding needing platelet transfusion; Grade ≥3 increased hepatic enzymes; Grade 3 or 4 non-haematologic toxicity with exceptions; Grade ≥2 infusion reaction despite adequate pre-medication; Grade ≥2 nausea and/or vomiting persisting for ≥7 days despite antiemetic treatment; Grade ≥3 skin toxicity despite adequate supportive care measures for up to 2 weeks if it does not reach an improvement to grade ≤2; Grade ≥3 hyperglycaemia resistant to treatment with anti-diabetic agents; any electrolyte grade 3 AE refractory to optimal correction therapy; no recovery from a non-DLT grade \>2 toxicity to grade 1 within 14 days of administered dose; sustained fatigue/asthenia grade 3 for \>96 h associated with deterioration of Performance score (Eastern Cooperative Oncology Group).

Outcome measures

Outcome measures
Measure	BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 Participants Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 Participants Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 Participants Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 Participants Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 Participants Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 Participants Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 Participants Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Percentage of Patients With Dose Limiting Toxicities (DLTs) During the First Treatment Course of the Dose Escalation Phase	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: First treatment administration, up to 246 days.

Population: TS

Best overall response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) based on RECIST criteria version 1.1: CR for target lesions: Disappearance of all target lesions. CR 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 (\<10 millimeters \[mm\] short axis). PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study. PD: At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm; Appearance of 1 or more new lesions; Unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 Participants Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 Participants Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 Participants Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 Participants Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 Participants Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 Participants Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 Participants Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=11 Participants Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=20 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 CR	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 PR	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 SD	33 Percentage of participants	33 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	33 Percentage of participants	33 Percentage of participants	33 Percentage of participants	67 Percentage of participants	67 Percentage of participants	33 Percentage of participants	36 Percentage of participants	45 Percentage of participants	—
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 PD	67 Percentage of participants	33 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	67 Percentage of participants	67 Percentage of participants	33 Percentage of participants	33 Percentage of participants	33 Percentage of participants	67 Percentage of participants	55 Percentage of participants	25 Percentage of participants	—
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 Not evaluable	0 Percentage of participants	33 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	33 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	9 Percentage of participants	30 Percentage of participants	—

SECONDARY outcome

Timeframe: First treatment administration, up to 246 days.

Population: TS

Objective response was defined as best overall response of CR or PR (with no confirmation required).

Outcome measures

Outcome measures
Measure	BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 Participants Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 Participants Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 Participants Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 Participants Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 Participants Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 Participants Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 Participants Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=11 Participants Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=20 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Objective Tumour Response	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—

SECONDARY outcome

Timeframe: First treatment administration, up to 246 days.

Population: TS. Only participants with objective response were included in the endpoint.

Duration of objective response (days), defined as time from first objective response to the time to progression or death and was only calculated for patients with an objective response (with no confirmation required).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First treatment administration, up to 246 days.

Population: TS

Disease control was defined as best overall response of CR, PR (confirmation was not required for CR or PR) or confirmed SD (i.e. lasting for at least 24 weeks).

Outcome measures

Outcome measures
Measure	BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 Participants Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 Participants Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 Participants Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 Participants Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 Participants Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 Participants Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 Participants Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=11 Participants Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=20 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Disease Control	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	33 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	33 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—

SECONDARY outcome

Timeframe: First treatment administration until tumour progression or death, up to 162 days.

Population: Treated set (TS) restricted to part 2 - dose expansion phase: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment in the dose expansion phase.

PFS was evaluated in expansion phase of the study. PFS was defined as the time from first treatment administration until tumour progression according to RECIST 1.1 or death from any cause, whichever occurred earlier.

Outcome measures

Outcome measures
Measure	BI 836845 n=10 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg n=14 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Progression-free Survival (PFS)	37.0 days Interval 30.0 to 86.0	79.0 days Interval 36.0 to 85.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: 5 minutes before and 0.5, 1, 2, 4, 7, 24, 72, 168 and 336 h after infusion for Course 1. Part 2: 5 minutes before and 1, 2, 4, 7, 24, 168, 169, 336, 337 h after infusion for Course 1, 2 and 3.

Population: Pharmacokinetic (PK) set: All patients in the treated set who were documented to have received at least one dose of BI 836845 and who had at least one valid PK parameter concentration available. PK data are reported based on the dosage administered to patients.

Maximum measured concentration of the analyte in plasma (Cmax) in the first cycle of treatment (dose escalation phase, part 1) and in the first 3 cycles of treatment (dose expansion phase, part 2).

Outcome measures

Outcome measures
Measure	BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 Participants Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 Participants Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 Participants Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 Participants Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 Participants Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 Participants Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 Participants Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=30 Participants Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=20 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 n=10 Participants Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Maximum Measured Concentration of the Analyte (BI 836845) in Plasma (Cmax)	2.45 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 10.6	5.24 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 46.1	10.7 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 65.8	17.7 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 17.9	66.2 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 113	196 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 163	146 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 47.8	421 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 30.8	727 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 101	554 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 11.5	1080 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 10.3	295 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 19.9	399 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 26.7	419 microgram/milliliter (µg/mL) Geometric Coefficient of Variation 26.5

SECONDARY outcome

Population: PK set. Only participants with available PK data are included in the analysis. PK data are reported based on the dosage administered to patients.

Area under the plasma concentration-time curve (AUC) of the analyte (BI 836845); AUC(0-504) in part 1 using 3- weekly dosing and AUC(0-168) in part 2 using weekly dosing.

Outcome measures

Outcome measures
Measure	BI 836845 n=2 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 Participants Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 Participants Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 Participants Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 Participants Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=2 Participants Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 Participants Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 Participants Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=27 Participants Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=18 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 n=8 Participants Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Area Under the Plasma Concentration-time Curve (AUC)	363 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 1.79	724 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 26.8	993 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 30.9	1910 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 50.5	5270 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 21.6	12100 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 27.6	17300 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 61.7	34600 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 68.2	42100 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 6.55	78500 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 6.32	87800 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 24.9	24100 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 22.1	37300 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 33.3	36900 microgramhour/milliliter (µgh/mL) Geometric Coefficient of Variation 41.6

SECONDARY outcome

Population: PK set. PK data are reported based on the dosage administered to patients.

Time to maximum measured concentration of the analyte in plasma (tmax) in the first cycle of treatment (dose escalation phase, part 1) and in the first 3 cycles of treatment (dose expansion phase, part 2).

Outcome measures

Outcome measures
Measure	BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 Participants Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 Participants Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 Participants Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 Participants Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 Participants Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 Participants Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 Participants Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=30 Participants Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=20 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 n=10 Participants Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Time to Maximum Measured Concentration of the Analyte (BI 836845) in Plasma (Tmax)	2.2 hours Full Range 10.6 • Interval 0.9 to 4.0	2.0 hours Full Range 46.1 • Interval 1.3 to 2.1	1.0 hours Full Range 65.8 • Interval 1.0 to 2.1	2.1 hours Full Range 17.9 • Interval 1.0 to 3.9	1.0 hours Full Range 113 • Interval 0.5 to 2.0	2.0 hours Full Range 163 • Interval 1.0 to 2.0	2.0 hours Full Range 47.8 • Interval 2.0 to 4.0	2.3 hours Full Range 30.8 • Interval 2.0 to 4.0	2.0 hours Full Range 101 • Interval 0.9 to 2.0	4.0 hours Full Range 11.5 • Interval 2.3 to 6.7	1.8 hours Full Range 10.3 • Interval 1.8 to 3.0	2.5 hours Full Range 19.9 • Interval 0.9 to 7.0	3.0 hours Full Range 26.7 • Interval 0.9 to 7.0	1.0 hours Full Range 26.5 • Interval 0.9 to 4.9

SECONDARY outcome

Timeframe: From first drug administration, until 21 days after last drug administration, up to 253 days.

Population: TS

Percentage of patients with adverse events (AEs) according to the grading as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, 14 June 2010 are presented. When no CTCAE grading was available for a specific event, the intensity of the AE was judged based on the following: * Grade 1 - Mild AE; awareness of sign(s) or symptom(s) which were easily tolerated. * Grade 2 - Moderate AE; enough discomfort to cause interference with usual activity. * Grade 3 - Severe AE; incapacitating or causing inability to work or to perform usual activities. * Grade 4 - Life-threatening or disabling AE. * Grade 5 - Death related to AE.

Outcome measures

Outcome measures
Measure	BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 Participants Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 Participants Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 Participants Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 Participants Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 Participants Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 Participants Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 Participants Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=11 Participants Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=20 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.	Course 3 Patients are administered BI 836845 weekly in course of 21 days by a 1-hour infusion at the start of each week during course 3 (in expansion part of study)
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1	66.7 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	18.2 Percentage of participants	25.0 Percentage of participants	—
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2	0.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	66.7 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	66.7 Percentage of participants	45.5 Percentage of participants	45.0 Percentage of participants	—
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3	0.0 Percentage of participants	66.7 Percentage of participants	33.3 Percentage of participants	66.7 Percentage of participants	33.3 Percentage of participants	100.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	66.7 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	27.3 Percentage of participants	30.0 Percentage of participants	—
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 4	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	9.1 Percentage of participants	0.0 Percentage of participants	—
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 5	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	—

Adverse Events

BI 836845 10 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 836845 20 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 836845 40 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 836845 80 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 836845 160 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 836845 320 mg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 836845 640 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 836845 1280 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

BI 836845 1800 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

BI 836845 2400 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 836845 3600 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Ewings Sarcoma

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Biopsiable Tumours

Serious events: 10 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BI 836845 10 mg n=3 participants at risk Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 20 mg n=3 participants at risk Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 participants at risk Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 participants at risk Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 participants at risk Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 participants at risk Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 participants at risk Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 participants at risk Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 participants at risk Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 participants at risk Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 participants at risk Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=11 participants at risk Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1- hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=20 participants at risk Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Cardiac disorders Pericardial effusion	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Cardiac disorders Pericarditis	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Eye disorders Eye swelling	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Nausea	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	10.0% 2/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Chest pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Pyrexia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Immune system disorders Hypersensitivity	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Aspergillus infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Device related infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Escherichia urinary tract infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Gastroenteritis norovirus	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Oral candidiasis	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Pneumonia	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Pseudomonas infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Sepsis	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Skin infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	10.0% 2/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Metabolism and nutrition disorders Hypophagia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Seizure	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Product Issues Device dislocation	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Renal and urinary disorders Urinary retention	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.

Other adverse events

Other adverse events
Measure	BI 836845 10 mg n=3 participants at risk Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 20 mg n=3 participants at risk Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 40 mg n=3 participants at risk Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 80 mg n=3 participants at risk Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 160 mg n=3 participants at risk Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 320 mg n=3 participants at risk Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 640 mg n=3 participants at risk Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1280 mg n=3 participants at risk Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 1800 mg n=3 participants at risk Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 2400 mg n=3 participants at risk Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	BI 836845 3600 mg n=3 participants at risk Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Ewings Sarcoma n=11 participants at risk Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1- hour infusion at the start of each week in expansion part of the study.	Biopsiable Tumours n=20 participants at risk Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	25.0% 5/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	10.0% 2/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Cardiac disorders Tachycardia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Ear and labyrinth disorders Eustachian tube obstruction	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Endocrine disorders Cushingoid	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Eye disorders Dry eye	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	15.0% 3/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Constipation	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	54.5% 6/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	10.0% 2/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	100.0% 3/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	20.0% 4/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	15.0% 3/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Flatulence	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Gingival erythema	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Nausea	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	27.3% 3/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	40.0% 8/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Chest pain	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	10.0% 2/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Toothache	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	27.3% 3/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	20.0% 4/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Catheter site erythema	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Chest discomfort	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Chills	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Crepitations	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Fatigue	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	70.0% 14/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Feeling cold	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Influenza like illness	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Infusion site pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Malaise	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Mucosal dryness	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Pyrexia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Suprapubic pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
General disorders Thirst	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	10.0% 2/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Candiduria	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Catheter site infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Ear infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Oral candidiasis	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Oral herpes	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Tooth abscess	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	25.0% 5/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Investigations Transaminases increased	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Investigations Weight decreased	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	15.0% 3/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	100.0% 3/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	35.0% 7/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	20.0% 4/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	27.3% 3/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Disturbance in attention	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Dizziness	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Dysgeusia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Headache	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Lethargy	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Loss of consciousness	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Neuralgia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Neurotoxicity	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Nervous system disorders Tremor	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	10.0% 2/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Psychiatric disorders Anxiety	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Psychiatric disorders Depressed mood	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Psychiatric disorders Depression	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Psychiatric disorders Insomnia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Renal and urinary disorders Haematuria	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Renal and urinary disorders Nocturia	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Reproductive system and breast disorders Nipple pain	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Reproductive system and breast disorders Perineal pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	66.7% 2/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	27.3% 3/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	27.3% 3/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	25.0% 5/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	5.0% 1/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	18.2% 2/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Vascular disorders Haematoma	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Vascular disorders Hypertension	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.
Vascular disorders Hypotension	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	33.3% 1/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/3 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	9.1% 1/11 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.	0.00% 0/20 • From first drug administration, until 21 days after last drug administration, up to 253 days. Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.

Additional Information

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Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

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.
Publication restrictions are in place

Restriction type: OTHER