Trial Outcomes & Findings for A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (NCT NCT02632721)

NCT ID: NCT02632721

Last Updated: 2024-03-19

Results Overview

Number of patients with dose limiting toxicity (DLT(s)) for BI 836858 in combination with decitabine during first treatment cycle (Phase 1). DLT was defined as any non-disease-related non-haematological adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher. Expected non-haematological disease-related AEs were not to be regarded as a DLT. These included complications resulting from haematological AEs such as: * Bleeding and complications from bleeding due to thrombocytopenia as defined by the Investigator, * Infection and complications from infections due to neutropenia as defined by the Investigator, * Constitutional symptoms due to anaemia as defined by the Investigator

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 49 participants
• Primary outcome timeframe: Up to 28 days (first treatment cycle).
• Results posted on: 2024-03-19

Participant Flow

This was an open-label, Phase I/II trial to determine the maximum tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine in patients with acute myeloid leukemia.

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

Measure	Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive) 20 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive) 40 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive) 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive) 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension B: BI 836858 80 mg + Decitabine (Standard) 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 5 consecutive days (standard treatment) from Day 1 to 5 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).
Overall Study STARTED	4	3	9	15	18
Overall Study COMPLETED	0	0	0	1	2
Overall Study NOT COMPLETED	4	3	9	14	16

Reasons for withdrawal

Measure	Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive) 20 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive) 40 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive) 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive) 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension B: BI 836858 80 mg + Decitabine (Standard) 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 5 consecutive days (standard treatment) from Day 1 to 5 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).
Overall Study Adverse Event	0	0	2	5	3
Overall Study Dose limiting toxicity	0	0	0	1	0
Overall Study Progressive disease	3	0	4	6	5
Overall Study Refused to continue taking trial medication	0	1	1	1	2
Overall Study Inadequate clinical condition	0	0	0	0	1
Overall Study No meet eligibility	0	0	0	0	1
Overall Study Allergic reaction	0	0	0	1	0
Overall Study Receiving Decitabine locally	0	0	1	0	0
Overall Study No benefit from study treatment	1	1	0	0	1
Overall Study Patient wish for other treatment	0	1	0	0	0
Overall Study Relapsed Pneumonia	0	0	0	0	1
Overall Study Therapy refractory AML	0	0	0	0	1
Overall Study Increase of white blood cell count	0	0	0	0	1
Overall Study Allogeneic peripheral blood stem cell transplantation	0	0	1	0	0

Baseline Characteristics

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Measure	Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive) n=4 Participants 20 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive) n=3 Participants 40 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive) n=9 Participants 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive) n=15 Participants 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension B: BI 836858 80 mg + Decitabine (Standard) n=18 Participants 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 5 consecutive days (standard treatment) from Day 1 to 5 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Total n=49 Participants Total of all reporting groups
Age, Continuous	72.0 Years STANDARD_DEVIATION 11.34 • n=93 Participants	52.3 Years STANDARD_DEVIATION 27.61 • n=4 Participants	66.3 Years STANDARD_DEVIATION 13.02 • n=27 Participants	74.9 Years STANDARD_DEVIATION 6.62 • n=483 Participants	76.6 Years STANDARD_DEVIATION 4.24 • n=36 Participants	72.3 Years STANDARD_DEVIATION 11.31 • n=10 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	7 Participants n=483 Participants	6 Participants n=36 Participants	20 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants	8 Participants n=483 Participants	12 Participants n=36 Participants	29 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants	15 Participants n=483 Participants	18 Participants n=36 Participants	49 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 28 days (first treatment cycle).

Population: Treated set: All subjects who were documented to have received at least one dose of trial medication.

Number of patients with dose limiting toxicity (DLT(s)) for BI 836858 in combination with decitabine during first treatment cycle (Phase 1).

DLT was defined as any non-disease-related non-haematological adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher. Expected non-haematological disease-related AEs were not to be regarded as a DLT.

These included complications resulting from haematological AEs such as:

• Bleeding and complications from bleeding due to thrombocytopenia as defined by the Investigator,
• Infection and complications from infections due to neutropenia as defined by the Investigator,
• Constitutional symptoms due to anaemia as defined by the Investigator

Outcome measures

Measure	Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive) n=4 Participants 20 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive) n=3 Participants 40 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive) n=9 Participants 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive) n=15 Participants 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension B: BI 836858 80 mg + Decitabine (Standard) n=18 Participants 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 5 consecutive days (standard treatment) from Day 1 to 5 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).
Phase I: Number of Patients With Dose Limiting Toxicity (DLT(s)) During First Treatment Cycle	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: From first drug administration until end of treatment, up to 941 days.

Population: Maximum Tolerated Dose (MTD) evaluable set: This analysis set includes all subjects who were entered, treated and completed first cycle of planned treatment or subjects received at least 2 doses of BI 836858 due to BI 836858-related toxicity but not replaced.

The Maximum tolerated dose (MTD) of BI 836858 in combination with decitabine was estimated after the dose escalation part of the trial obtaining on the basis of dose limiting toxicities (DLT(s)) observed during the first treatment cycle. However, for those patients who receive more than one cycle of the combination treatment, all adverse events that constitute a DLT will be considered for re-estimation of the MTD based on the Bayesian logistic regression model (BLRM). The MTD is defined as the highest dose of BI 836858 (in combination with decitabine) with less than 25% risk of the true DLT rate being above 33% during the MTD evaluation period.

Outcome measures

Measure	Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive) n=35 Participants 20 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive) 40 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive) 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive) 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension B: BI 836858 80 mg + Decitabine (Standard) 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 5 consecutive days (standard treatment) from Day 1 to 5 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).
Phase I: Maximum Tolerated Dose (MTD) of BI 836858 in Combination With Decitabine	NA milligram No formal MTD was determined due to no DLTs were reported during dose escalation and only 2 DLTs were observed in the extension phase.	—	—	—	—

SECONDARY outcome

Timeframe: From start of treatment until the earliest of progression, death or end of trial, up to 971 days.

Population: Treated set: All subjects who were documented to have received at least one dose of trial medication.

Number of patients with objective response (Complete remission (CR) + complete remission with incomplete remission (CRi)).

CR was defined as bone marrow (BM) blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 109/L [1,000/μL]; platelet count > 100 x 109/L [100,000/μL]; independence of red blood cells transfusions (no transfusion for 1 week prior to the assessment). No minimum duration of response is required.

CRi was defined as all CR criteria except for residual neutropenia (< 1.0 x 109/L [1,000/μL]) or thrombocytopenia (< 100 x 109/L [100,000/μL]).

Outcome measures

Measure	Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive) n=4 Participants 20 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive) n=3 Participants 40 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive) n=9 Participants 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive) n=15 Participants 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension B: BI 836858 80 mg + Decitabine (Standard) n=18 Participants 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 5 consecutive days (standard treatment) from Day 1 to 5 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).
Phase 1: Number of Patients With Objective Response (CR + CRi) Objective response (CR + CRi)	2 Participants	0 Participants	6 Participants	7 Participants	4 Participants
Phase 1: Number of Patients With Objective Response (CR + CRi) Complete remission (CR)	1 Participants	0 Participants	1 Participants	3 Participants	3 Participants
Phase 1: Number of Patients With Objective Response (CR + CRi) Complete remission with incomplete recovery (CRi)	1 Participants	0 Participants	5 Participants	4 Participants	1 Participants

Adverse Events

Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive)

Serious events: 4 serious events

Other events: 4 other events

Deaths: 3 deaths

Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive)

Serious events: 8 serious events

Other events: 9 other events

Deaths: 5 deaths

Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive)

Serious events: 14 serious events

Other events: 15 other events

Deaths: 11 deaths

Phase I Extension B: BI 836858 80 mg + Decitabine (Standard)

Serious events: 17 serious events

Other events: 18 other events

Deaths: 13 deaths

Serious adverse events

Measure	Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive) n=4 participants at risk 20 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive) n=3 participants at risk 40 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive) n=9 participants at risk 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive) n=15 participants at risk 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension B: BI 836858 80 mg + Decitabine (Standard) n=18 participants at risk 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 5 consecutive days (standard treatment) from Day 1 to 5 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Febrile neutropenia	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	55.6% 5/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 5/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	27.8% 5/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders White blood cell disorder	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Acute myocardial infarction	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Atrioventricular block complete	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Cardiac arrest	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Cardiac failure	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Tachyarrhythmia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Enteritis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders General physical health deterioration	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Mucosal inflammation	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Non-cardiac chest pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Pyrexia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Atypical pneumonia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Bacterial infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Biliary tract infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Cardiac valve abscess	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Clostridium difficile infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Device related infection	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Endocarditis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Escherichia infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Influenza	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Pneumonia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 4/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Sepsis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	16.7% 3/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Septic shock	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Urinary tract infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Cervical vertebral fracture	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Fall	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Subdural haematoma	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Thoracic vertebral fracture	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood fibrinogen decreased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 5/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	27.8% 5/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Facial nerve disorder	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Haemorrhage intracranial	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Hypoglossal nerve paresis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Intraventricular haemorrhage	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Status epilepticus	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Syncope	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Transient ischaemic attack	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Delirium	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Acute kidney injury	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Renal failure	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Deep vein thrombosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.

Other adverse events

Measure	Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive) n=4 participants at risk 20 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive) n=3 participants at risk 40 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive) n=9 participants at risk 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive) n=15 participants at risk 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 10 consecutive days (intensive treatment) from Day 1 to 10 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).	Phase I Extension B: BI 836858 80 mg + Decitabine (Standard) n=18 participants at risk 80 milligram (mg) of concentrate for solution for infusion of BI 836858 were administered as single dose via rate-controlled intravenous infusion once per week in 28-day treatment cycle (i.e. on Days 1, 8, 15, and 22 of the 28-day treatment cycles), together with 20 mg/square meter (m2) body surface area (BSA) of decitabine administered daily via intravenous infusion for 5 consecutive days (standard treatment) from Day 1 to 5 in each treatment cycle. The BI 836858 dose was diluted in 0.9% sodium chloride to have full volume of the diluted compound 250 milliliter (mL).
Psychiatric disorders Nervousness	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Restlessness	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Sleep disorder	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Persistent depressive disorder	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Dysuria	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Acquired antithrombin III deficiency	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Anaemia	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 6/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	26.7% 4/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 6/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Leukopenia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Blood and lymphatic system disorders Thrombotic microangiopathy	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Atrial fibrillation	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Atrioventricular block	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Bradycardia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Cardiovascular disorder	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Left ventricular dysfunction	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Mitral valve incompetence	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Cardiac disorders Tachycardia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Ear and labyrinth disorders Tinnitus	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Ear and labyrinth disorders Vertigo	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Eye disorders Diplopia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Eye disorders Dry eye	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Eye disorders Eye haematoma	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Eye disorders Eye haemorrhage	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Eye disorders Eyelid bleeding	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Eye disorders Eyelid oedema	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Eye disorders Macular oedema	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Eye disorders Vitreous floaters	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Abdominal pain	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Anal fissure	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Anal incontinence	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Anal inflammation	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Constipation	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	44.4% 4/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	46.7% 7/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 6/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Diarrhoea	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	26.7% 4/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Dysphagia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Flatulence	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Glossodynia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Haematochezia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Haemorrhoids	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Mouth haemorrhage	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Nausea	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	100.0% 3/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	40.0% 6/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Odynophagia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Oral discomfort	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Proctalgia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Proctitis	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Stomatitis	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Toothache	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Gastrointestinal disorders Vomiting	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	100.0% 3/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 5/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Asthenia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Catheter site pain	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Catheter site thrombosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Chest discomfort	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Chest pain	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Chills	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Face oedema	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Fatigue	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Gait disturbance	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders General physical health deterioration	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Implant site pain	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Inflammation	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Injection site reaction	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Localised oedema	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Malaise	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Mucosal inflammation	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 4/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Oedema peripheral	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	44.4% 4/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	46.7% 7/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 6/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Pain	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Peripheral swelling	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Puncture site pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Pyrexia	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	26.7% 4/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 4/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Systemic inflammatory response syndrome	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Treatment noncompliance	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Vessel puncture site pain	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Vessel puncture site swelling	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Hepatobiliary disorders Cholelithiasis	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Immune system disorders Hypersensitivity	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Bacterial infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Bronchitis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Cerebral fungal infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Device related infection	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Ecthyma	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Endocarditis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Enterococcal infection	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Herpes simplex viraemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Intervertebral discitis	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Lip infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Localised infection	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Mucosal infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Nail infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Nasopharyngitis	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Oral candidiasis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Oral herpes	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Oral infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Otitis media	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Pneumonia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	16.7% 3/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Rhinitis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Sinusitis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Skin candida	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Urinary tract infection	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Vaginal infection	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Contusion	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Fall	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 4/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Infusion related reaction	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	100.0% 3/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	44.4% 4/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	53.3% 8/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	61.1% 11/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Refractoriness to platelet transfusion	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Skin injury	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Subcutaneous haematoma	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Injury, poisoning and procedural complications Transplantation complication	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Alanine aminotransferase increased	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood bilirubin increased	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood calcium decreased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood creatinine increased	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood fibrinogen decreased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood potassium decreased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood sodium increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood urea increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Blood uric acid increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations C-reactive protein increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Cortisol decreased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Ejection fraction decreased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Electrocardiogram QT prolonged	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Gamma-glutamyltransferase increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations International normalised ratio increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Lymphocyte count decreased	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Neutrophil count decreased	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Platelet count decreased	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	44.4% 4/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	27.8% 5/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Prothrombin time prolonged	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Prothrombin time shortened	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Transaminases increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Weight decreased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations Weight increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations White blood cell count decreased	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	27.8% 5/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Investigations White blood cell count increased	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Cachexia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Decreased appetite	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	16.7% 3/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Gout	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hyperglycaemia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hyperuricaemia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hypokalaemia	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 4/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	26.7% 4/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Muscular weakness	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Spinal pain	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Balance disorder	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Dizziness	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Facial paralysis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Headache	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	26.7% 4/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	16.7% 3/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Hypoaesthesia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Hypogeusia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Hypoglossal nerve paresis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Neuropathy peripheral	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Peripheral motor neuropathy	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Polyneuropathy	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Presyncope	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Restless legs syndrome	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Somnolence	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Syncope	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	16.7% 3/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Nervous system disorders Tremor	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Anxiety	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Confusional state	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Depression	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Disorientation	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Hallucination	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Insomnia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	16.7% 3/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Haematuria	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Incontinence	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Micturition urgency	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Nocturia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Oliguria	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Pollakiuria	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Renal failure	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Renal haematoma	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Urethral haemorrhage	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Renal and urinary disorders Urinary retention	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Reproductive system and breast disorders Penile haemorrhage	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 6/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 2/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	26.7% 4/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 4/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Hypoxia	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Nasal dryness	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Pulmonary pain	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Tachypnoea	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Erythema	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	20.0% 3/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	16.7% 3/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Flushing	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Haematoma	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	16.7% 3/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Hypertension	75.0% 3/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	66.7% 2/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 3/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	26.7% 4/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Hypotension	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	13.3% 2/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 2/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Jugular vein thrombosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	11.1% 1/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Phlebitis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Thrombophlebitis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	22.2% 2/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Thrombosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	33.3% 1/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Venous thrombosis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
General disorders Illness	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations COVID-19	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Cellulitis	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Infections and infestations Herpes zoster	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Psychiatric disorders Depressed mood	0.00% 0/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	6.7% 1/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.
Vascular disorders Superficial vein thrombosis	25.0% 1/4 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/3 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/9 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	0.00% 0/15 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.	5.6% 1/18 • From first administration of trial medication until 30 days of residual effect period after the last administration of trial medication, up to 971 days. Treated set: All subjects who were documented to have received at least one dose of trial medication.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

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

Restriction type: OTHER