Trial Outcomes & Findings for Dose Finding Study of BI 836880 in Patients With Solid Tumors (NCT NCT02674152)

Last Updated: 2025-10-01

Results Overview

Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being above 0.33 during the MTD evaluation period, defined as 3 weeks after first administration of trial medication (i.e. cycle 1). Patients who did not complete the MTD evaluation period for reasons other than DLT were excluded from the analysis of the primary endpoint.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

29 participants

Primary outcome timeframe

Up to 3 weeks after the first administration of trial medication.

Results posted on

2025-10-01

Participant Flow

A non-randomized, open-label, multi-center dose escalation trial to determine the maximum tolerated dose and recommended Phase 2 dose of BI 836880 in patients with advanced or metastatic/refractory solid tumours.

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

Participant milestones

Participant milestones
Measure	720 mg BI 836880 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	40 mg BI 836880 40 milligrams (mg) BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.
Overall Study STARTED	17	5	3	2	2
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	17	5	3	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	720 mg BI 836880 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	40 mg BI 836880 40 milligrams (mg) BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.
Overall Study Personal Reasons	1	1	1	0	0
Overall Study Other adverse event or clinical progression	3	0	0	1	0
Overall Study Dose-limiting toxicity	0	1	0	0	0
Overall Study Progressive Disease	13	2	2	1	1
Overall Study Adverse Event	0	1	0	0	1

Baseline Characteristics

Dose Finding Study of BI 836880 in Patients With Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	40 mg BI 836880 n=3 Participants 40 milligrams (mg) BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 n=2 Participants 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 n=2 Participants 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	720 mg BI 836880 n=17 Participants 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 n=5 Participants 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	Total n=29 Participants Total of all reporting groups
Age, Continuous	57.7 Years STANDARD_DEVIATION 8.1 • n=5 Participants	70.5 Years STANDARD_DEVIATION 6.4 • n=7 Participants	47.0 Years STANDARD_DEVIATION 9.9 • n=5 Participants	56.7 Years STANDARD_DEVIATION 14.2 • n=4 Participants	49.4 Years STANDARD_DEVIATION 13.2 • n=21 Participants	55.8 Years STANDARD_DEVIATION 13.4 • n=10 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants	3 Participants n=21 Participants	18 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	11 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants	2 Participants n=21 Participants	20 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants	2 Participants n=21 Participants	20 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 3 weeks after the first administration of trial medication.

Population: Dose-finding cohort treated set: All patients enrolled in dose finding and confirmation of MTD cohort of the trial who were documented to have taken at least 1 dose of study medication and were evaluable for the MTD determination.

Outcome measures

Outcome measures
Measure	BI 836880 - All Dose Groups n=17 Participants 40/120/360/720 or 1000 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	720 mg BI 836880 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.
Maximum Tolerated Dose (MTD)	720 Milligram	—	—	—	—

PRIMARY outcome

Timeframe: Up to 3 weeks after the first administration of trial medication.

DTLs are defined as followed: * Drug-related Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non-haematological toxicity * CTCAE Grade 4 neutropenia lasting \>7 days or complicated by infection (please note that in case of grade 4 neutropenia a more frequent follow up of patient was necessary * Febrile neutropenia of CTCAE Grade ≥3 * CTCAE Grade 4 thrombocytopenia or CTCAE Grade ≥3 thrombocytopenia with bleeding * Treatment delay for \>2 weeks due to unresolved drug-related AEs, which started within 3 weeks after the first treatment * Hypertension: increase of diastolic blood pressure (DBP) by 15 millimetre of mercury (mmHg) confirmed by a second measurement or by ambulatory blood pressure measurement (when indicated, e.g. white coat effect) which could not be controlled by hypertensive medication and required a dose reduction of BI 836880 for further treatment cycle * Proteinuria: urinary protein ≥3.5 gram/day (CTCAE Grade 3)

Outcome measures

Outcome measures
Measure	BI 836880 - All Dose Groups n=2 Participants 40/120/360/720 or 1000 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 n=2 Participants 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 n=2 Participants 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	720 mg BI 836880 n=7 Participants 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 n=4 Participants 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.
Number of Patients With Dose-limiting Toxicities (DLT) in the Maximum Tolerated Dose (MTD) Period	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days.

Population: Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of trial medication.

Number of patients with drug-related adverse events leading to dose reduction or discontinuation during treatment period.

Outcome measures

Outcome measures
Measure	BI 836880 - All Dose Groups n=3 Participants 40/120/360/720 or 1000 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 n=2 Participants 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 n=2 Participants 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	720 mg BI 836880 n=17 Participants 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 n=5 Participants 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.
Number of Patients With Drug-related Adverse Events Leading to Dose Reduction or Discontinuation During Treatment Period	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 minutes before start of BI 836880 infusion and immediately after end of infusion (i.e. 1.5 hours (h) after start of infusion) and 2h, 3h, 5h, 8h, 24h, 72h, 168h, 336h and 504h after start of BI 826880 infusion in cycle 1.

Population: Pharmacokinetic (PK) analysis set: All patients who were treated and provided at least 1 observation for at least 1 PK endpoint without an important protocol deviation relevant to PK evaluations.

Area under the serum concentration-time curve over the time interval from 0 extrapolated to infinity (AUC0-tz) after the first dose.

Outcome measures

Outcome measures
Measure	BI 836880 - All Dose Groups n=3 Participants 40/120/360/720 or 1000 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 n=2 Participants 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 n=2 Participants 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	720 mg BI 836880 n=17 Participants 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 n=5 Participants 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.
Area Under the Serum Concentration-time Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-tz) After the First Dose	2180 Microgram * hours/ milliliter Geometric Coefficient of Variation 152	4100 Microgram * hours/ milliliter Geometric Coefficient of Variation 38.7	15000 Microgram * hours/ milliliter Geometric Coefficient of Variation 71.1	32900 Microgram * hours/ milliliter Geometric Coefficient of Variation 28.1	40000 Microgram * hours/ milliliter Geometric Coefficient of Variation 66.6

SECONDARY outcome

Terminal half-life (t\_1/2) of BI 836880.

Outcome measures

Outcome measures
Measure	BI 836880 - All Dose Groups n=2 Participants 40/120/360/720 or 1000 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 n=2 Participants 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 n=2 Participants 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	720 mg BI 836880 n=16 Participants 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 n=4 Participants 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.
Terminal Half-life (t_1/2) of BI 836880	241 Hours Geometric Coefficient of Variation 16.3	210 Hours Geometric Coefficient of Variation 5.07	265 Hours Geometric Coefficient of Variation 7.42	289 Hours Geometric Coefficient of Variation 19.1	279 Hours Geometric Coefficient of Variation 8.96

Adverse Events

40 mg BI 836880

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

120 mg BI 836880

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

360 mg BI 836880

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

720 mg BI 836880

Serious events: 6 serious events

Other events: 17 other events

Deaths: 4 deaths

1000 mg BI 836880

Serious events: 5 serious events

Other events: 5 other events

Deaths: 2 deaths

Total BI 836880

Serious events: 15 serious events

Other events: 29 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	40 mg BI 836880 n=3 participants at risk 40 milligrams (mg) BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 n=2 participants at risk 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 n=2 participants at risk 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	720 mg BI 836880 n=17 participants at risk 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 n=5 participants at risk 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	Total BI 836880 n=29 participants at risk 40/120/360/720 or 1000 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.
General disorders Death	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Cardiac disorders Myocarditis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Constipation	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Gastritis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Ileus	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Mechanical ileus	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Subileus	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Impaired healing	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Hepatobiliary disorders Bile duct stone	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Hepatobiliary disorders Cholelithiasis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Hepatobiliary disorders Hepatic pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Hepatobiliary disorders Hepatomegaly	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Device related infection	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Herpes zoster	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Infection	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Peritonitis bacterial	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Pneumonia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Sepsis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Blood bilirubin increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Vascular disorders Hypertension	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.

Other adverse events

Other adverse events
Measure	40 mg BI 836880 n=3 participants at risk 40 milligrams (mg) BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	120 mg BI 836880 n=2 participants at risk 120 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	360 mg BI 836880 n=2 participants at risk 360 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	720 mg BI 836880 n=17 participants at risk 720 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	1000 mg BI 836880 n=5 participants at risk 1000 mg BI 836880 solution for infusion were administered intravenous as as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. Administration was continued until disease progression or until intolerable toxicities had been observed, up to 786 days. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.	Total BI 836880 n=29 participants at risk 40/120/360/720 or 1000 mg BI 836880 solution for infusion were administered intravenous as rate-controlled infusion once per treatment cycle (21 days) in patients with advanced or metastatic solid tumour. The pharmaceutical formulation was diluted with 50ml/vial to prepare solution for infusion of BI 836880.
Investigations Electrocardiogram T wave inversion	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	23.5% 4/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	17.2% 5/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Injury, poisoning and procedural complications Stoma site inflammation	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Injury, poisoning and procedural complications Stoma site rash	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	11.8% 2/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	60.0% 3/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	17.2% 5/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Amylase increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	41.2% 7/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	31.0% 9/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	10.3% 3/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Blood bilirubin increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	17.6% 3/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	17.2% 5/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Blood creatinine increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations C-reactive protein increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Lipase increased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Investigations Weight decreased	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Metabolism and nutrition disorders Acidosis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	17.6% 3/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.7% 6/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	13.8% 4/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	11.8% 2/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Nervous system disorders Dysaesthesia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Nervous system disorders Dysgeusia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Nervous system disorders Headache	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Nervous system disorders Sciatica	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Psychiatric disorders Anxiety	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Psychiatric disorders Depression	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Psychiatric disorders Insomnia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Renal and urinary disorders Dysuria	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Renal and urinary disorders Haematuria	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Renal and urinary disorders Micturition urgency	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Renal and urinary disorders Proteinuria	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	10.3% 3/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Renal and urinary disorders Renal failure	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Reproductive system and breast disorders Pelvic pain	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	10.3% 3/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	100.0% 2/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	23.5% 4/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.7% 6/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	11.8% 2/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Sinus pain	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	11.8% 2/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Vascular disorders Hypertension	100.0% 3/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	100.0% 2/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	100.0% 2/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	88.2% 15/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	80.0% 4/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	89.7% 26/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Vascular disorders Lymphoedema	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Vascular disorders Raynaud's phenomenon	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	35.3% 6/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	27.6% 8/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Blood and lymphatic system disorders Leukopenia	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Blood and lymphatic system disorders Lymphopenia	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	11.8% 2/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	13.8% 4/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	11.8% 2/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Cardiac disorders Palpitations	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Endocrine disorders Hypothyroidism	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	10.3% 3/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Eye disorders Dry eye	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Eye disorders Eyelid haematoma	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	17.6% 3/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	24.1% 7/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	11.8% 2/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	13.8% 4/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Ascites	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Chest pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	10.3% 3/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Colitis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Constipation	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	29.4% 5/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	27.6% 8/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	29.4% 5/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	27.6% 8/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Flatulence	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Gastritis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	11.8% 2/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	10.3% 3/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Melaena	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	52.9% 9/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	60.0% 3/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	44.8% 13/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Oesophageal pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Toothache	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	35.3% 6/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	37.9% 11/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Asthenia	66.7% 2/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	58.8% 10/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	51.7% 15/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Chills	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Face oedema	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Fatigue	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Hernia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Impaired healing	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Localised oedema	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Mucosal inflammation	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Oedema peripheral	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	23.5% 4/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	24.1% 7/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Peripheral swelling	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
General disorders Pyrexia	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	17.6% 3/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	10.3% 3/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Hepatobiliary disorders Cholelithiasis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Hepatobiliary disorders Hepatic pain	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Immune system disorders Allergy to immunoglobulin therapy	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Immune system disorders Hypersensitivity	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	17.6% 3/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	10.3% 3/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Cystitis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Gastroenteritis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Herpes zoster	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Infection	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Influenza	33.3% 1/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	13.8% 4/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Oral fungal infection	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	5.9% 1/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Respiratory tract infection	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Rhinitis	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	11.8% 2/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	40.0% 2/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.7% 6/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	3.4% 1/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	50.0% 1/2 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	0.00% 0/17 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	20.0% 1/5 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.	6.9% 2/29 • From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days. Treated Set (TS): The TS included all patients enrolled in the trial who were documented to have taken at least 1 dose of study medication.

Additional Information

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