Trial Outcomes & Findings for BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour (NCT NCT00969761)

NCT ID: NCT00969761

Last Updated: 2019-01-31

Results Overview

The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin. 0=not maximum tolerated dose, 1=was maximum tolerated dose.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 61 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2019-01-31

Participant Flow

An open-label, parallel group, 3+3 dose escalation trial Volasertib and cisplatin or carboplatin combination therapy was given on Day 1 of up to 6, 3-week cycles.

For the carboplatin arm, the target doses were calculated using the Calvert formula to achieve AUC 4, AUC 5 and AUC 6. Calvert formula: Dose (mg) = target AUC x (glomerular filtration rate (GFR) + 25); GFR = (140 - age [years]) x (actual weight [kg])/(72 x serum creatinine [mg/dL]). Multiply by another factor of 0.85 if female).

Participant milestones

Measure	V200+Cis75 Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis60 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Discont. Before Start of Treat. Cycle 2 STARTED	3	3	12	6	3	3	3	6	13	3	3	3
Discont. Before Start of Treat. Cycle 2 COMPLETED	2	3	10	5	3	3	3	6	11	2	3	3
Discont. Before Start of Treat. Cycle 2 NOT COMPLETED	1	0	2	1	0	0	0	0	2	1	0	0
Treated in and Beyond Treat. Cycle 2 STARTED	2	3	10	5	3	3	3	6	11	2	3	3
Treated in and Beyond Treat. Cycle 2 COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Treated in and Beyond Treat. Cycle 2 NOT COMPLETED	2	3	10	5	3	3	3	6	11	2	3	3

Reasons for withdrawal

Measure	V200+Cis75 Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis60 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Discont. Before Start of Treat. Cycle 2 Progressive Disease	1	0	0	1	0	0	0	0	1	1	0	0
Discont. Before Start of Treat. Cycle 2 Dose Limiting Toxicity (DLT)	0	0	1	0	0	0	0	0	0	0	0	0
Discont. Before Start of Treat. Cycle 2 Other adverse events	0	0	1	0	0	0	0	0	0	0	0	0
Discont. Before Start of Treat. Cycle 2 Withdrawal by Subject	0	0	0	0	0	0	0	0	1	0	0	0
Treated in and Beyond Treat. Cycle 2 Progressive disease	2	3	10	3	2	3	3	6	9	2	3	3
Treated in and Beyond Treat. Cycle 2 Other adverse events	0	0	0	2	1	0	0	0	2	0	0	0

Baseline Characteristics

BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour

Baseline characteristics by cohort

Measure	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	Total n=61 Participants Total of all reporting groups
Age, Continuous	40.7 Years STANDARD_DEVIATION 7.51 • n=5 Participants	55.0 Years STANDARD_DEVIATION 12.53 • n=7 Participants	52.5 Years STANDARD_DEVIATION 16.67 • n=5 Participants	60.0 Years STANDARD_DEVIATION 9.53 • n=4 Participants	56.3 Years STANDARD_DEVIATION 11.72 • n=21 Participants	54.0 Years STANDARD_DEVIATION 5.57 • n=8 Participants	58.0 Years STANDARD_DEVIATION 13.75 • n=8 Participants	66.3 Years STANDARD_DEVIATION 10.07 • n=24 Participants	51.8 Years STANDARD_DEVIATION 13.03 • n=42 Participants	58.3 Years STANDARD_DEVIATION 6.66 • n=42 Participants	45.0 Years STANDARD_DEVIATION 19.16 • n=42 Participants	58.3 Years STANDARD_DEVIATION 7.37 • n=42 Participants	54.7 Years STANDARD_DEVIATION 13.08 • n=36 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	6 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	27 Participants n=36 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	7 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	34 Participants n=36 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: Treated set

The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin.

0=not maximum tolerated dose, 1=was maximum tolerated dose.

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Maximum Tolerated Dose	0 Units on a scale	0 Units on a scale	0 Units on a scale	0 Units on a scale	1 Units on a scale	0 Units on a scale	0 Units on a scale	0 Units on a scale	0 Units on a scale	0 Units on a scale	1 Units on a scale	0 Units on a scale

SECONDARY outcome

Timeframe: 3 weeks

Population: Treated set. There was one patient in the V300+Car6 group whose DLT data was not evaluable, so only 12 patients had evaluable data.

Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle.

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Percentage of Participants With Dose Limiting Toxicities	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	25.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	16.7 Percentage of participants	66.7 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Objective response was defined as the proportion of participants having at least a best response of complete response (CR) or partial response (PR) determined based on RECIST criteria, version 1.0 (V1.0).

Tumour response was documented using appropriate techniques

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Objective Response Rate	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	7.7 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set restricted to participants with confirmed objective response.

Duration of objective response was defined as the time from first documented confirmed complete response (CR) or partial response (PR) to first evidence of progressive disease (PD) or death from any cause, whichever occurred first, determined based on RECIST V1.0 criteria.

Tumour response was documented using appropriate techniques

Outcome measures

Measure	V100+Cis60 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=1 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=1 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=1 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=1 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Duration of Objective Response	—	298 Days Interval 298.0 to 298.0	—	359 Days Interval 359.0 to 359.0	—	—	—	—	—	282 Days Interval 282.0 to 282.0	207 Days Interval 207.0 to 207.0	—

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Best overall response was defined as the best response obtained since the start of study treatment until disease progression, determined based on RECIST V1.0 criteria.

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Best Overall Response Complete response	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Best Overall Response Partial response	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	7.7 Percentage of participants	0.0 Percentage of participants
Best Overall Response Stable disease	66.7 Percentage of participants	66.7 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	25.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	7.7 Percentage of participants	33.3 Percentage of participants
Best Overall Response Progressive disease	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	58.3 Percentage of participants	50.0 Percentage of participants	66.7 Percentage of participants	66.7 Percentage of participants	100.0 Percentage of participants	33.3 Percentage of participants	61.5 Percentage of participants	33.3 Percentage of participants
Best Overall Response Non evaluable	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Best Overall Response No post-baseline tumour assessment	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	23.1 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Percentage of participants with confirmed disease control, defined as the proportion of patients with a best overall response of at least stable disease (SD), determined based on RECIST V1.0 criteria.

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Disease Control Rate	66.7 Percentage of participants	100.0 Percentage of participants	33.3 Percentage of participants	66.7 Percentage of participants	25.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	50.0 Percentage of participants	15.4 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set restricted to participants with confirmed disease control.

Duration of Disease control was defined as the time from the start of study treatment to the time of disease progression or death, whichever occurred first.

Outcome measures

Measure	V100+Cis60 n=2 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=1 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=2 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=2 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=1 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=1 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=2 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=1 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Duration of Disease Control	196.5 Days Standard Deviation 103.94	309.0 Days Standard Deviation 105.93	264.0 Days Standard Deviation NA Not calculable as data only available for one patient	268.0 Days Standard Deviation 237.59	155.0 Days Standard Deviation 49.36	103.5 Days Standard Deviation 9.19	135.0 Days Standard Deviation NA Not calculable as data only available for one patient	229.0 Days Standard Deviation NA Not calculable as data only available for one patient	—	234.0 Days Standard Deviation 115.99	190.5 Days Standard Deviation 74.25	126.0 Days Standard Deviation NA Not calculable as data only available for one patient

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Progression-free survival based on RECIST V1.0 criteria was defined as the time from start of treatment to the date of evidence of progressive disease (PD) or death from any cause, whichever occurred first.

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Progression-free Survival	123.0 Days Interval 38.0 to 270.0	309.0 Days Interval 143.0 to 340.0	37.0 Days Interval 1.0 to 264.0	100.0 Days Interval 43.0 to 436.0	49.5 Days Interval 1.0 to 232.0	69.5 Days Interval 21.0 to 169.0	80.0 Days Interval 37.0 to 135.0	64.0 Days Interval 36.0 to 229.0	40.0 Days Interval 36.0 to 43.0	71.0 Days Interval 38.0 to 331.0	43.0 Days Interval 1.0 to 243.0	39.0 Days Interval 13.0 to 126.0

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 Grade 1	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	8.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 Grade 2	0.0 Percentage of participants	0.0 Percentage of participants	66.7 Percentage of participants	33.3 Percentage of participants	8.3 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	66.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 Grade 3	100.0 Percentage of participants	100.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	41.7 Percentage of participants	50.0 Percentage of participants	66.7 Percentage of participants	66.7 Percentage of participants	33.3 Percentage of participants	50.0 Percentage of participants	61.5 Percentage of participants	33.3 Percentage of participants
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 Grade 4	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	66.7 Percentage of participants	41.7 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	50.0 Percentage of participants	23.1 Percentage of participants	66.7 Percentage of participants
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 Grade 5	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	15.4 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Percentage of participants with serious adverse events (AEs)

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Percentage of Participants With Serious Adverse Events	66.7 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	50.0 Percentage of participants	50.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	16.7 Percentage of participants	46.2 Percentage of participants	66.7 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Percentage of participants with significant adverse events (AEs): dose limiting toxicity (DLT) was defined as significant AE.

DLTs (i.e. significant AEs) per protocol were:

• drug related CTCAE grade 3 or 4 non haematological toxicity (except vomiting or diarrhoea responding to supportive treatment and ototoxicity)
• drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection
• drug related CTCAE Grade 4 thrombocytopenia
• drug related febrile neutropenia grade 3 (ANC<1000/mm³ and fever≥ 38.5°C)

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Percentage of Participants With Significant Adverse Events	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	66.7 Percentage of participants	25.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	15.4 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion

Population: Pharmacokinetic (PK) set which included all participants in the treated set with evaluable PK data

Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=2 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=11 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=10 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Total Plasma Clearance After Intravascular Administration (CL)	852 mL/min Geometric Coefficient of Variation 28.1	1130 mL/min Geometric Coefficient of Variation 28.1	1090 mL/min Geometric Coefficient of Variation 7.60	1050 mL/min Geometric Coefficient of Variation 22.7	971 mL/min Geometric Coefficient of Variation 28.6	1010 mL/min Geometric Coefficient of Variation 47.9	1110 mL/min Geometric Coefficient of Variation 33.6	812 mL/min Geometric Coefficient of Variation 11.7	881 mL/min Geometric Coefficient of Variation 6.92	808 mL/min Geometric Coefficient of Variation 20.7	974 mL/min Geometric Coefficient of Variation 19.1	546 mL/min Geometric Coefficient of Variation 16.7

SECONDARY outcome

Timeframe: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion

Population: PK set

Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=2 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=11 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=10 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)	6580 Litres Geometric Coefficient of Variation 66.9	11100 Litres Geometric Coefficient of Variation 20.1	5570 Litres Geometric Coefficient of Variation 18.9	7140 Litres Geometric Coefficient of Variation 42.5	5880 Litres Geometric Coefficient of Variation 67.6	7270 Litres Geometric Coefficient of Variation 41.5	8810 Litres Geometric Coefficient of Variation 38.7	9960 Litres Geometric Coefficient of Variation 44.7	8950 Litres Geometric Coefficient of Variation 36.9	8270 Litres Geometric Coefficient of Variation 42.2	7440 Litres Geometric Coefficient of Variation 31.9	3640 Litres Geometric Coefficient of Variation 35.9

SECONDARY outcome

Timeframe: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Change from baseline in pulse rate at last value on treatment

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Change From Baseline in Pulse Rate	10.0 bpm Standard Deviation 10.00	23.3 bpm Standard Deviation 15.01	6.7 bpm Standard Deviation 17.24	-11.7 bpm Standard Deviation 14.29	10.3 bpm Standard Deviation 14.35	5.2 bpm Standard Deviation 10.34	3.7 bpm Standard Deviation 26.50	0.7 bpm Standard Deviation 7.37	12.0 bpm Standard Deviation 7.55	5.7 bpm Standard Deviation 10.61	14.4 bpm Standard Deviation 10.97	-21.7 bpm Standard Deviation 17.79

SECONDARY outcome

Timeframe: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Change from baseline in neutrophils with the maximum value on treatment

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Change From Baseline in Neutrophils	7.6 10^9 cells /L Standard Deviation 7.3	3.3 10^9 cells /L Standard Deviation 1.9	3.4 10^9 cells /L Standard Deviation 2.3	3.0 10^9 cells /L Standard Deviation 2.6	6.0 10^9 cells /L Standard Deviation 4.3	5.2 10^9 cells /L Standard Deviation 6.5	2.1 10^9 cells /L Standard Deviation 3.1	6.8 10^9 cells /L Standard Deviation 8.2	3.6 10^9 cells /L Standard Deviation 2.7	5.9 10^9 cells /L Standard Deviation 6.9	5.5 10^9 cells /L Standard Deviation 2.4	4.7 10^9 cells /L Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Change from baseline in platelets with the maximum value on treatment

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Change From Baseline in Platelets	57 10^9 cells /L Standard Deviation 48	65 10^9 cells /L Standard Deviation 78	96 10^9 cells /L Standard Deviation 94	71 10^9 cells /L Standard Deviation 58	67 10^9 cells /L Standard Deviation 58	89 10^9 cells /L Standard Deviation 95	186 10^9 cells /L Standard Deviation 96	50 10^9 cells /L Standard Deviation 38	49 10^9 cells /L Standard Deviation 65	39 10^9 cells /L Standard Deviation 20	73 10^9 cells /L Standard Deviation 58	104 10^9 cells /L Standard Deviation 53

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Frequency of participants (%) with possible clinically significant abnormalities for neutrophils: : defined as neutrophils >=CTCAE grade 2 (CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils	33.0 Percentage of participants	100.0 Percentage of participants	0.0 Percentage of participants	66.7 Percentage of participants	75.0 Percentage of participants	50.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	83.3 Percentage of participants	76.9 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Frequency of participants (%) with possible clinically significant abnormalities for platelets : defined as platelets >=CTCAE grade 2 (based on CTCAE v3.0), with worsening from baseline.

The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.0 Percentage of participants	41.7 Percentage of participants	83.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	83.3 Percentage of participants	76.9 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on last value on treatment.

Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment Baseline=0, last value=0	33.3 Percentage of participants	66.7 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	83.3 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	66.7 Percentage of participants	66.7 Percentage of participants	83.3 Percentage of participants	84.6 Percentage of participants	100.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment Baseline=0, last value=1	33.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	7.7 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment Baseline=1, last value=0	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment Baseline=0, last value=2	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	7.7 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment Baseline=0, last value=3	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment Baseline=1, last value=1	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on last value on treatment.

Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment Baseline=0, last value=0	100.0 Percentage of participants	66.7 Percentage of participants	100.0 Percentage of participants	66.7 Percentage of participants	91.7 Percentage of participants	66.7 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	83.3 Percentage of participants	69.2 Percentage of participants	100.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment Baseline=0, last value=1	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	30.8 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment Baseline=0, last value=3	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	8.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment Baseline=1, last value=1	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment Baseline=0, last value=2	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment Baseline=0, last value=4	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment Baseline=1, last value=0	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on worst value on treatment.

Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment Baseline=0, worst value=0	33.3 Percentage of participants	66.7 Percentage of participants	66.7 Percentage of participants	0.0 Percentage of participants	25.0 Percentage of participants	16.7 Percentage of participants	66.7 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	16.7 Percentage of participants	7.7 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment Baseline=0, worst value=1	33.3 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	66.7 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	66.7 Percentage of participants	0.0 Percentage of participants	15.4 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment Baseline=0, worst value=2	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	8.3 Percentage of participants	66.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	15.4 Percentage of participants	33.3 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment Baseline=0, worst value=3	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	38.5 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment Baseline=1, worst value=1	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment Baseline=0, worst value=4	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	23.1 Percentage of participants	66.7 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment Baseline=1, worst value=4	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment Baseline=1, worst value=0	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on worst value on treatment.

Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment Baseline=1, worst value=4	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment Baseline=0, worst value=0	33.3 Percentage of participants	0.0 Percentage of participants	100.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	16.7 Percentage of participants	66.7 Percentage of participants	66.7 Percentage of participants	66.7 Percentage of participants	16.7 Percentage of participants	7.7 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment Baseline=0, worst value=1	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	8.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	15.4 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment Baseline=0, worst value=2	33.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	25.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	16.7 Percentage of participants	15.4 Percentage of participants	0.0 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment Baseline=0, worst value=3	0.0 Percentage of participants	66.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	53.8 Percentage of participants	66.7 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment Baseline=0, worst value=4	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants	33.3 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	50.0 Percentage of participants	7.7 Percentage of participants	33.3 Percentage of participants
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment Baseline=1, worst value=3	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Worst CTCAE Grade on Treatment for Platelets	1 Units on a scale 48	1 Units on a scale 78	1 Units on a scale 94	2 Units on a scale 58	3 Units on a scale 58	3 Units on a scale 95	1 Units on a scale 96	3 Units on a scale 38	1 Units on a scale 65	4 Units on a scale 20	4 Units on a scale 58	4 Units on a scale 53

SECONDARY outcome

Timeframe: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Population: Treated set

Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).

Outcome measures

Measure	V100+Cis60 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Cis75 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 Participants Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 Participants Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 Participants Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 Participants Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Worst CTCAE Grade on Treatment for Neutrophils	2 Units on a scale	3 Units on a scale	0 Units on a scale	4 Units on a scale	4 Units on a scale	4 Units on a scale	3 Units on a scale	3 Units on a scale	2 Units on a scale	4 Units on a scale	4 Units on a scale	4 Units on a scale

Adverse Events

V200+Cis75

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

V300+Cis75

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

V300+Cis100

Serious events: 6 serious events

Other events: 12 other events

Deaths: 0 deaths

V350+Cis75

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

V100+Car4

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

V100+Car5

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

V200+Car5

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

V300+Car5

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

V300+Car6

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

V350+Car5

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

V100+Cis60

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

V100+Cis75

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	V200+Cis75 n=3 participants at risk Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 participants at risk Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 participants at risk Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 participants at risk Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 participants at risk Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 participants at risk Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 participants at risk Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 participants at risk Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 participants at risk Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 participants at risk Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis60 n=3 participants at risk Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 participants at risk Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Nausea	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	25.0% 3/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Vomiting	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 4/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Chest pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Fatigue	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders General physical health deterioration	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 2/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Pyrexia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Systemic inflammatory response syndrome	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Respiratory tract infection	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Sepsis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Septic shock	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Staphylococcal infection	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Urinary tract infection	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Blood creatinine increased	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 2/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour compression	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Nervous system disorders Paraparesis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Axillary vein thrombosis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Deep vein thrombosis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Hypotension	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Jugular vein thrombosis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Orthostatic hypotension	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Other adverse events

Measure	V200+Cis75 n=3 participants at risk Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis75 n=3 participants at risk Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Cis100 n=12 participants at risk Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 100mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Cis75 n=6 participants at risk Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car4 n=3 participants at risk Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC4 (area under the curve of 4) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Car5 n=3 participants at risk Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V200+Car5 n=3 participants at risk Patients received 200mg Volasertib (V200) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car5 n=6 participants at risk Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V300+Car6 n=13 participants at risk Patients received 300mg Volasertib (V300) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC6 (area under the curve of 6) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V350+Car5 n=3 participants at risk Patients received 350mg Volasertib (V350) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus AUC5 (area under the curve of 5) carboplatin (Car) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis60 n=3 participants at risk Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 60mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.	V100+Cis75 n=3 participants at risk Patients received 100mg Volasertib (V100) administered by intravenous infusion over 2 hours at day 1 of each treatment cycle, plus 75mg/m2 cisplatin (Cis) administered by intravenous infusion over 1 hour at day 1 of each treatment cycle.
Nervous system disorders Cauda equina syndrome	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 8/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 4/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 6/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	92.3% 12/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	75.0% 9/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 4/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	83.3% 5/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	84.6% 11/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Blood and lymphatic system disorders Lymphopenia	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	58.3% 7/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	50.0% 3/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 6/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	61.5% 8/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	75.0% 9/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 4/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	83.3% 5/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	92.3% 12/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	75.0% 9/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	83.3% 5/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	83.3% 5/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	92.3% 12/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Cardiac disorders Atrial fibrillation	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Ear and labyrinth disorders Deafness	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	41.7% 5/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Eye disorders Cataract	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Eye disorders Eyelid oedema	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Eye disorders Ophthalmoplegia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Eye disorders Vision blurred	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Abdominal pain upper	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Anal fissure	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Constipation	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 4/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	50.0% 3/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 2/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	46.2% 6/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 2/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Duodenitis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	15.4% 2/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Faecal vomiting	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Gastritis	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Nausea	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	91.7% 11/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	50.0% 3/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	50.0% 3/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	46.2% 6/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Oesophagitis	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Regurgitation	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 2/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Toothache	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Gastrointestinal disorders Vomiting	100.0% 3/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	83.3% 10/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 2/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	38.5% 5/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Asthenia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Catheter site pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Catheter site phlebitis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Chest discomfort	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Chest pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Chills	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Fatigue	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 8/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 4/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	50.0% 3/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	61.5% 8/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Mucosal inflammation	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Oedema	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Oedema peripheral	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 2/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	15.4% 2/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
General disorders Pyrexia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Hepatobiliary disorders Hepatic pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Immune system disorders Hypersensitivity	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Bronchitis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Cellulitis	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Cystitis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Hepatitis B	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Infection	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 2/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Nasopharyngitis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Oral herpes	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Pharyngitis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Pneumonia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Respiratory tract infection	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Tooth abscess	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Urinary tract infection	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	15.4% 2/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Infections and infestations Vulvovaginal candidiasis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Alanine aminotransferase increased	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Blood creatinine increased	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 2/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	15.4% 2/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Blood potassium decreased	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Neutrophil count	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Troponin T increased	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Weight decreased	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Investigations Weight increased	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	58.3% 7/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 4/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	46.2% 6/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 2/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Nervous system disorders Dizziness	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Nervous system disorders Dysgeusia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Nervous system disorders Headache	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	15.4% 2/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Nervous system disorders Paraesthesia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	25.0% 3/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Nervous system disorders Syncope	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Psychiatric disorders Anxiety	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Psychiatric disorders Bradyphrenia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Psychiatric disorders Disorientation	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Psychiatric disorders Hallucination	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Psychiatric disorders Insomnia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Psychiatric disorders Sleep disorder	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Renal and urinary disorders Dysuria	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Renal and urinary disorders Pyuria	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Renal and urinary disorders Renal impairment	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 2/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 2/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	15.4% 2/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	15.4% 2/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	66.7% 2/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 2/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Skin and subcutaneous tissue disorders Capillaritis	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Circulatory collapse	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Haemorrhage	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	8.3% 1/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Hot flush	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Hypertension	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	16.7% 1/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	33.3% 1/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Hypotension	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Orthostatic hypotension	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Vascular disorders Phlebitis superficial	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/12 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/6 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	7.7% 1/13 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days	0.00% 0/3 • From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Additional Information

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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