Trial Outcomes & Findings for Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes (NCT NCT02240706)

Last Updated: 2020-12-21

Results Overview

The MTD is defined as the highest dose of BI 836858 with less than 25% risk of the true dose-limiting toxicity (DLT) rate being above 33% during the MTD evaluation period. MTD determination will be based on a Bayesian logistic regression model with overdose control. For any dose-escalation cohort, at least 3 patients (pts) will be required. However, in the case that only 2 pts are evaluable and neither has experienced a DLT within the first cycle (2 administrations - 28 days), then dose-escalation can occur based on these 2 pts. After all pts in a cohort have either experienced a DLT or have been observed for at least one cycle (2 administrations - 28 days) without experiencing a DLT, the Bayesian model will be updated with the newly accumulated data. The MTD may be considered reached if either the posterior probability of the true DLT rate in the target interval (16%-33%) is above 50%, or at least 12 pts have been treated at MTD, including the two expansion cohorts.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

From the first administration of BI 836858 to start of the third administration of BI 836858, excluding the day of the third administration of BI 836858, up to 28 days

Results posted on

2020-12-21

Participant Flow

This is a phase I/II, multicenter, open-label, dose escalation and randomized trial of BI 836858 in patients with low or intermediate-1 risk myelodysplastic syndromes.

Subjects were screened for eligibility prior to participation. They attended a specialist site which ensured that they strictly met all eligibility 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 836858 20 mg (Phase I) All patients were administered doses of BI 836858, 20 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Overall Study STARTED	3	3	6	4	11
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	6	4	11

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 836858 20 mg (Phase I) All patients were administered doses of BI 836858, 20 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Overall Study Lack of Efficacy	2	2	2	2	5
Overall Study Adverse Event	1	0	1	0	2
Overall Study Progressive disease	0	0	0	0	1
Overall Study Dose limiting toxicity	0	0	0	0	1
Overall Study Refused to continue taking medication	0	1	3	1	2
Overall Study Insurance billing concerns	0	0	0	1	0

Baseline Characteristics

Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 836858 20 mg (Phase I) n=3 Participants All patients were administered doses of BI 836858, 20 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) n=3 Participants All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) n=6 Participants All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) n=4 Participants All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) n=11 Participants All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	Total n=27 Participants Total of all reporting groups
Age, Continuous	71.0 Years STANDARD_DEVIATION 5.57 • n=93 Participants	75.0 Years STANDARD_DEVIATION 6.24 • n=4 Participants	73.8 Years STANDARD_DEVIATION 16.41 • n=27 Participants	68.3 Years STANDARD_DEVIATION 12.18 • n=483 Participants	75.6 Years STANDARD_DEVIATION 5.08 • n=36 Participants	73.6 Years STANDARD_DEVIATION 9.56 • n=10 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	4 Participants n=36 Participants	7 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants	20 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants	4 Participants n=483 Participants	11 Participants n=36 Participants	27 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants	4 Participants n=483 Participants	11 Participants n=36 Participants	27 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: From the first administration of BI 836858 to start of the third administration of BI 836858, excluding the day of the third administration of BI 836858, up to 28 days

Population: As the study was prematurely discontinued, recruitment of participants into the dose escalation part was not fully completed. No formal MTD was determined.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From the first administration of BI 836858 to start of the third administration of BI 836858, excluding the day of the third administration of BI 836858, up to 28 days

Population: MTD evaluation set: All patients who were documented to have initiated at least one dose of BI 836858 and who have not been replaced for the MTD evaluation.

Dose Limiting Toxicity (DLT): * Grade (G) ≥ 3 (CTCAE 4.0), non disease-related, non-hematologic adverse events (AE), except: * Laboratory abnormality, not significant by investigator or resolves spontaneously or can be recovered with appropriate treatment (T) within 5 d * Neutrophils (NP) \<500 /microliters (μL) at T start, febrile neutropenia with NP \<500 /μL or infection with NP \<500 /μL will not constitute a DLT if they can be recovered with appropriate T within 14 d * Inability to deliver study drug full dose according to the assigned dose level within cycle 1 due to drug-related AEs * Absence of hematological recovery as following: * NPs: G 4 (if G 0/1 at baseline (BL)) OR \<100 /μL and decrease of \>75% from BL (if G ≥2 at BL) for \>7 d * Platelets: G 4 (if G 0/1 at BL) OR \< 10000/μL for \>7 d and decrease of \>75% from BL (if G ≥2 at BL) * T delay of ≥4 weeks of start of Cycle 2 --If Cycle 2 is not started until 57th d as a result of drug related AE, it is considered as DLT

Outcome measures

Outcome measures
Measure	BI 836858 n=2 Participants Treatment group "BI 836858" comprises all dose cohorts during the dose escalation phase, that is, "BI 836858 20 mg", "BI 836858 40 mg", "BI 836858 80 mg", "BI 836858 160 mg" and "BI 836858 320 mg". All patients were administered doses of BI 836858, by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) n=3 Participants All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) n=6 Participants All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) n=4 Participants All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) n=9 Participants All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Number of Patients With Dose Limiting Toxicity (DLT) (Phase I)	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: From first administration of BI 836858 until discontinuation of the treatment. Up to 168 days (6 cycles, each of 28 days)

Population: No patients were enrolled in the Phase II part. The company decided to stop the clinical development of BI 836858 prematurely during the Phase I expansion cohort stage for strategic reasons.

Red blood cell (RBC) transfusion independence and platelet transfusion independence will be evaluated in patients who are transfusion dependent at baseline. Percentages will be calculated using all treated patients as the denominator. A patient is considered transfusion independent at baseline if the patient has had no transfusions during the 56 days prior to and including the first day of treatment. Otherwise, the patient is considered to be transfusion dependent. A patient is considered transfusion independent if the patient has had no transfusions over the course of ≥ 56 consecutive days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first administration of BI 836858 until discontinuation of the treatment. Up to 168 days (6 cycles, each of 28 days)

Population: Treated set (TS): The TS included all patients who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.

Number of patients with red blood cell (RBC) Transfusion Independency is presented. Red blood cell (RBC) transfusion independence and platelet transfusion independence will be evaluated in patients who are transfusion dependent at baseline. Percentages will be calculated using all treated patients as the denominator. A patient is considered transfusion independent at baseline if the patient has had no transfusions during the 56 days prior to and including the first day of treatment. Otherwise, the patient is considered to be transfusion dependent. A patient is considered transfusion independent if the patient has had no transfusions over the course of ≥ 56 consecutive days.

Outcome measures

Outcome measures
Measure	BI 836858 n=3 Participants Treatment group "BI 836858" comprises all dose cohorts during the dose escalation phase, that is, "BI 836858 20 mg", "BI 836858 40 mg", "BI 836858 80 mg", "BI 836858 160 mg" and "BI 836858 320 mg". All patients were administered doses of BI 836858, by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) n=3 Participants All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) n=6 Participants All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) n=4 Participants All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) n=11 Participants All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Number of Patients With Red Blood Cell (RBC) Transfusion Independency (Phase I)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first administration of BI 836858 until HI-N, up to 168 days (6 cycles, each of 28 days)

Population: Treated set (TS): The TS included all patients who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.

Number of patients with hematologic improvement neutrophils (HI-N) is presented. The HI will be evaluated in patients with abnormal pretreatment values defined as follows: Neutrophil response (HI-N) - Patients with a pretreatment neutrophil count \<1 x 10\^9/liters (L) demonstrate a neutrophil response if they have an at least 100 percent increase and an absolute increase \>0.5 x 10\^9/L.

Outcome measures

Outcome measures
Measure	BI 836858 n=3 Participants Treatment group "BI 836858" comprises all dose cohorts during the dose escalation phase, that is, "BI 836858 20 mg", "BI 836858 40 mg", "BI 836858 80 mg", "BI 836858 160 mg" and "BI 836858 320 mg". All patients were administered doses of BI 836858, by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) n=3 Participants All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) n=6 Participants All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) n=4 Participants All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) n=11 Participants All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Number of Patients With Hematologic Improvement Neutrophils (HI-N) (Phase I)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first administration of BI 836858 until HI-P, up to 168 days (6 cycles, each of 28 days)

Population: Treated set (TS): The TS included all patients who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.

Number of patients with hematologic improvement platelets (HI-P) is presented. The HI will be evaluated in patients with abnormal pretreatment values defined as follows: Platelet response (HI-P) - Patients with a pretreatment platelet count \<100 x 109/Liters (L) demonstrate a platelet response if there is an absolute platelet increase of ≥30 x 109/L for patients starting with \>20 x 109/L platelets. For those with an increase from 10 x 109/L to \>20 x 109/L must have an increase of at least 100 percent.

Outcome measures

Outcome measures
Measure	BI 836858 n=3 Participants Treatment group "BI 836858" comprises all dose cohorts during the dose escalation phase, that is, "BI 836858 20 mg", "BI 836858 40 mg", "BI 836858 80 mg", "BI 836858 160 mg" and "BI 836858 320 mg". All patients were administered doses of BI 836858, by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) n=3 Participants All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) n=6 Participants All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) n=4 Participants All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) n=11 Participants All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Number of Patients With Hematologic Improvement Platelets (HI-P) (Phase I)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first administration of BI 836858 until HI-E, up to 168 days (6 cycles, each of 28 days)

Population: Treated set (TS): The TS included all patients who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.

Number of patients with hematologic improvement erythroid (HI-E) is presented. The HI will be evaluated in patients with abnormal pretreatment values defined as follows: Erythroid response (HI-E): Patients with a pretreatment hemoglobin \<11 grams per deciliters (g/dL) demonstrate erythroid response if their hemoglobin increases by ≥1.5 g/dL for at least eight weeks, and there is a reduction in the units of red cell transfusions by an absolute number of at least four red cell transfusions per eight weeks compared with the pretreatment transfusion number in the previous eight weeks. Only red cell transfusions given for a hemoglobin ≤9 g/dL pretreatment will count in the red cell transfusion response evaluation.

Outcome measures

Outcome measures
Measure	BI 836858 n=3 Participants Treatment group "BI 836858" comprises all dose cohorts during the dose escalation phase, that is, "BI 836858 20 mg", "BI 836858 40 mg", "BI 836858 80 mg", "BI 836858 160 mg" and "BI 836858 320 mg". All patients were administered doses of BI 836858, by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) n=3 Participants All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) n=6 Participants All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) n=4 Participants All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) n=11 Participants All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Number of Patients With Hematologic Improvement Erythroid (HI-E) (Phase I)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first administration of BI 836858 until HI-E response, up to 168 days (6 cycles, each of 28 days)

Population: Treated set (TS): The TS included all patients who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses. Only patients who showed a HI-E response were included.

Time to HI-E response is defined only for patients who achieve a HI-E response as follows: Time to HI-E response \[days\] = date of first assessment indicating HI-E response - date of first administration of trial medication + 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: Treated set (TS): The TS included all patients who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.

Number of patients with mean hemoglobin increase ≥ 1.5 grams per deciliters (g/dL) is presented. Mean hemoglobin increase ≥ 1.5 g/dL - Proportion of subjects achieving hemoglobin (Hgb) increase from baseline ≥ 1.5 g/dL over any consecutive 56-day period in absence of Red blood cell (RBC) transfusions.

Outcome measures

Outcome measures
Measure	BI 836858 n=3 Participants Treatment group "BI 836858" comprises all dose cohorts during the dose escalation phase, that is, "BI 836858 20 mg", "BI 836858 40 mg", "BI 836858 80 mg", "BI 836858 160 mg" and "BI 836858 320 mg". All patients were administered doses of BI 836858, by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) n=3 Participants All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) n=6 Participants All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) n=4 Participants All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) n=11 Participants All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Number of Patients With Mean Hemoglobin Increase ≥ 1.5 g/dL (Phase I)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From the first date of achieving a response until the date of relapse, up to 168 days (6 cycles, each of 28 days)

Defined only for patients who achieve complete Response (CR) or marrow complete response (mCR) or RBC Transfusion independency (TI), measured from first date of achieving response until date of relapse. Date of relapse will be earliest of dates of disease assessment (blood sample, bone marrow sample, or clinical assessment) in which relapse was observed. For patients who die or are lost to follow-up without documented relapse, response duration will be censored, respectively, on date of death, regardless of cause, or on date of last disease assessment for patients who are alive when lost to follow-up. Duration of Response \[days\] = date of outcome - date of first assessment indicating CR or mCR or RBC TI after first administration of trial medication + 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first administration of BI 836858 until overall objective response, up to 168 days (6 cycles, each of 28 days)

Population: Treated set (TS): The TS included all patients who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.

Number of patients with overall Objective Response (OR) \[Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI)\] is presented. Overall Objective Response is defined as Complete Response (CR), Partial Response (PR), HI-N, HI-P, or HI-E. A patient's " Overall Objective Response " = "Yes" if one of these responses was reported at least once throughout the trial. CR defined as: -Bone marrow: \<5 % blasts with normal maturation of all cell lines (Dysplastic changes should consider the normal range of dysplastic changes), persistent dysplasia will be noted; -Peripheral blood: Hgb \> 11 grams per deciliters (g/dL), Platelets \>100 x 109/liters (L), Neutrophils \> 1.0 x 109/L, Blasts 0 % PR defined as: -All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by \>50 % to pre-treatment but still \>5 %, Cellularity and morphology not relevant. HI Definition see other endpoints.

Outcome measures

Outcome measures
Measure	BI 836858 n=3 Participants Treatment group "BI 836858" comprises all dose cohorts during the dose escalation phase, that is, "BI 836858 20 mg", "BI 836858 40 mg", "BI 836858 80 mg", "BI 836858 160 mg" and "BI 836858 320 mg". All patients were administered doses of BI 836858, by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40 mg (Phase I) n=3 Participants All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80 mg (Phase I) n=6 Participants All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160 mg (Phase I) n=4 Participants All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320 mg (Phase I) n=11 Participants All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Number of Patients With Overall Objective Response (OR) [Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI)] (Phase I)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

BI 836858 20mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

BI 836858 40mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 836858 80mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

BI 836858 160mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

BI 836858 320mg

Serious events: 6 serious events

Other events: 9 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	BI 836858 20mg n=3 participants at risk All patients were administered doses of BI 836858, 20 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40mg n=3 participants at risk All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80mg n=6 participants at risk All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160mg n=4 participants at risk All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320mg n=11 participants at risk All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Cardiac disorders Acute coronary syndrome	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Cardiac disorders Ventricular tachycardia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Non-cardiac chest pain	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Pyrexia	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Cellulitis	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Enterocolitis infectious	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Infection	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Sepsis	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Staphylococcal infection	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Wound infection	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	18.2% 2/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Nervous system disorders Syncope	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Psychiatric disorders Delirium	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Renal and urinary disorders Renal cyst	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Vascular disorders Hypotension	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.

Other adverse events

Other adverse events
Measure	BI 836858 20mg n=3 participants at risk All patients were administered doses of BI 836858, 20 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 40mg n=3 participants at risk All patients were administered doses of BI 836858, 40 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 80mg n=6 participants at risk All patients were administered doses of BI 836858, 80 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 160mg n=4 participants at risk All patients were administered doses of BI 836858, 160 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.	BI 836858 320mg n=11 participants at risk All patients were administered doses of BI 836858, 320 milligrams (mg) by a rate-controlled intravenous infusion on day 1 and on day 15 of a 28-day cycle for a duration of 4 cycles. All infusions were to be started at a rate of 10 mL/h. The infusion rate was to be increased every 30 (+/-10) minutes by 10 mL/h to a maximum of 80 mL/h as long as tolerated by the patient.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	66.7% 2/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	18.2% 2/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Hyperuricaemia	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	66.7% 2/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	27.3% 3/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Blood and lymphatic system disorders Monocytopenia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Cardiac disorders Angina pectoris	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	66.7% 2/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Cardiac disorders Atrioventricular block first degree	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Cardiac disorders Palpitations	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Cardiac disorders Tachycardia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Eye disorders Vision blurred	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Constipation	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	50.0% 3/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Faeces discoloured	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Hiatus hernia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Nausea	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	50.0% 3/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	50.0% 2/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	50.0% 3/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Catheter site pain	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Chest pain	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Chills	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Face oedema	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Fatigue	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Influenza like illness	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Infusion site pain	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Localised oedema	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Oedema peripheral	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Pain	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Pyrexia	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
General disorders Swelling	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Arthritis infective	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Cellulitis	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Cystitis	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Diverticulitis	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Enterococcal infection	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Pneumonia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Postoperative wound infection	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Staphylococcal infection	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Tinea cruris	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Tinea pedis	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Urinary tract infection	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Infections and infestations Wound infection	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	18.2% 2/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	66.7% 2/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	83.3% 5/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	100.0% 4/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	63.6% 7/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Scratch	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations Alanine aminotransferase increased	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations Blood bilirubin increased	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations Blood creatinine increased	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations Blood pressure increased	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations Carotid bruit	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations Neutrophil count decreased	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	66.7% 2/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	27.3% 3/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations Platelet count decreased	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations QRS axis abnormal	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations Weight decreased	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Investigations White blood cell count decreased	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	66.7% 2/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	27.3% 3/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	50.0% 2/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	18.2% 2/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Metabolism and nutrition disorders Iron overload	66.7% 2/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	50.0% 2/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Musculoskeletal and connective tissue disorders Muscular weakness	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Nervous system disorders Dizziness	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	50.0% 2/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Nervous system disorders Dysarthria	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Nervous system disorders Dysgeusia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Nervous system disorders Headache	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 2/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Nervous system disorders Memory impairment	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Nervous system disorders Paraesthesia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Psychiatric disorders Agitation	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	18.2% 2/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Psychiatric disorders Anxiety	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Psychiatric disorders Insomnia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	50.0% 2/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	9.1% 1/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	16.7% 1/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Vascular disorders Flushing	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Vascular disorders Haematoma	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Vascular disorders Hot flush	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	25.0% 1/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Vascular disorders Hypotension	33.3% 1/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/3 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/6 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/4 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.	0.00% 0/11 • From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up. Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.

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