Trial Outcomes & Findings for Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers (NCT NCT02696616)

NCT ID: NCT02696616

Last Updated: 2023-01-25

Results Overview

The number of subjects with drug-related adverse events.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

47 participants

Primary outcome timeframe

up to 99 days after start of drug administration

Results posted on

2023-01-25

Participant Flow

Single-rising dose trial, partially randomised within dose groups, placebo-controlled, single-blind, parallel-group design with 6 dose groups.

All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that the subjects met all strictly implemented inclusion and none of the exclusion criteria. Subjects would not have been treated with the trial treatment if any one of the specific entry criteria had been violated.

Participant milestones

Participant milestones
Measure	Placebo Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes	BI 655088 2 mg BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 6 mg BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 20 mg BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 50 mg BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 100 mg BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 200 mg BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes
Overall Study STARTED	12	5	6	6	6	6	6
Overall Study COMPLETED	12	4	6	6	6	6	6
Overall Study NOT COMPLETED	0	1	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes	BI 655088 2 mg BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 6 mg BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 20 mg BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 50 mg BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 100 mg BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 200 mg BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes
Overall Study Adverse Event	0	1	0	0	0	0	0

Baseline Characteristics

Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=12 Participants Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes	BI 655088 2 mg n=5 Participants BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 6 mg n=6 Participants BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 20 mg n=6 Participants BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 50 mg n=6 Participants BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 100 mg n=6 Participants BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 200 mg n=6 Participants BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	Total n=47 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 8.5 • n=5 Participants	42.0 years STANDARD_DEVIATION 9.4 • n=7 Participants	33.0 years STANDARD_DEVIATION 5.0 • n=5 Participants	42.3 years STANDARD_DEVIATION 7.5 • n=4 Participants	43.7 years STANDARD_DEVIATION 6.3 • n=21 Participants	34.0 years STANDARD_DEVIATION 9.7 • n=10 Participants	37.8 years STANDARD_DEVIATION 9.5 • n=115 Participants	38.1 years STANDARD_DEVIATION 8.5 • n=24 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	47 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	46 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	5 Participants n=115 Participants	42 Participants n=24 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: up to 99 days after start of drug administration

Population: Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, and disposition.

The number of subjects with drug-related adverse events.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes	BI 655088 2 mg n=5 Participants BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 6 mg n=6 Participants BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 20 mg n=6 Participants BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 50 mg n=6 Participants BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 100 mg n=6 Participants BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 200 mg n=6 Participants BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes
Number of Subjects With Drug-related Adverse Events	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 2016 hours. See endpoint description for a detailed timeframe.

Population: Pharmacokinetic (PK) parameter analysis set: This subject set included all subjects who were documented to have received at least 1 dose of BI 655088 and who provided at least 1 PK endpoint value that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability).

Maximum measured concentration of BI 655088 in plasma (Cmax). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes	BI 655088 2 mg n=6 Participants BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 6 mg n=6 Participants BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 20 mg n=6 Participants BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 50 mg n=6 Participants BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 100 mg n=6 Participants BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 200 mg BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes
Maximum Measured Concentration of BI 655088 in Plasma (Cmax)	0.593 microgram (µg) / millilitre (mL) Geometric Coefficient of Variation 8.98	1.69 microgram (µg) / millilitre (mL) Geometric Coefficient of Variation 15.8	5.76 microgram (µg) / millilitre (mL) Geometric Coefficient of Variation 24.9	13.1 microgram (µg) / millilitre (mL) Geometric Coefficient of Variation 12.5	17.3 microgram (µg) / millilitre (mL) Geometric Coefficient of Variation 66.2	48.8 microgram (µg) / millilitre (mL) Geometric Coefficient of Variation 4.90	—

SECONDARY outcome

Timeframe: Up to 2016 hours. See endpoint description for a detailed timeframe.

AUC0-tz (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 to the last quantifiable data point). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes	BI 655088 2 mg n=6 Participants BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 6 mg n=6 Participants BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 20 mg n=6 Participants BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 50 mg n=6 Participants BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 100 mg n=5 Participants BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 200 mg BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes
Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	12.5 microgram (µg)∙hour (h)/millilitre (mL) Geometric Coefficient of Variation 22.8	63.8 microgram (µg)∙hour (h)/millilitre (mL) Geometric Coefficient of Variation 13.2	392 microgram (µg)∙hour (h)/millilitre (mL) Geometric Coefficient of Variation 21.2	1250 microgram (µg)∙hour (h)/millilitre (mL) Geometric Coefficient of Variation 17.0	2360 microgram (µg)∙hour (h)/millilitre (mL) Geometric Coefficient of Variation 124	7210 microgram (µg)∙hour (h)/millilitre (mL) Geometric Coefficient of Variation 18.3	—

SECONDARY outcome

Timeframe: Up to 2016 hours. See endpoint description for a detailed timeframe.

AUC0-∞ (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 extrapolated to infinity). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes	BI 655088 2 mg n=6 Participants BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 6 mg n=6 Participants BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 20 mg n=6 Participants BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 50 mg n=6 Participants BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 100 mg n=6 Participants BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	BI 655088 200 mg BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes
Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)	12.9 microgram (µg)∙hour (h) /millilitre(mL) Geometric Coefficient of Variation 24.4	65.7 microgram (µg)∙hour (h) /millilitre(mL) Geometric Coefficient of Variation 11.9	395 microgram (µg)∙hour (h) /millilitre(mL) Geometric Coefficient of Variation 21.3	1250 microgram (µg)∙hour (h) /millilitre(mL) Geometric Coefficient of Variation 17.0	2360 microgram (µg)∙hour (h) /millilitre(mL) Geometric Coefficient of Variation 124	7010 microgram (µg)∙hour (h) /millilitre(mL) Geometric Coefficient of Variation 17.9	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

2 mg BI

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

6 mg BI

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

20 mg BI

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

50 mg BI

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

100 mg BI

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

200 mg BI

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=12 participants at risk Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes	2 mg BI n=5 participants at risk BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes	6 mg BI n=6 participants at risk BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	20 mg BI n=6 participants at risk BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	50 mg BI n=6 participants at risk BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	100 mg BI n=6 participants at risk BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	200 mg BI n=6 participants at risk BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes
Cardiac disorders Acute myocardial infarction	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Infections and infestations Pathogen resistance	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.

Other adverse events

Other adverse events
Measure	Placebo n=12 participants at risk Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes	2 mg BI n=5 participants at risk BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes	6 mg BI n=6 participants at risk BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	20 mg BI n=6 participants at risk BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	50 mg BI n=6 participants at risk BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	100 mg BI n=6 participants at risk BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes	200 mg BI n=6 participants at risk BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Gastrointestinal disorders Nausea	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Gastrointestinal disorders Vomiting	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Gastrointestinal disorders Diarrhoea	16.7% 2/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Gastrointestinal disorders Toothache	16.7% 2/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Gastrointestinal disorders Dry mouth	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Gastrointestinal disorders Flatulence	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Infections and infestations Nasopharyngitis	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	33.3% 2/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Infections and infestations Gastroenteritis	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Infections and infestations Oral herpes	16.7% 2/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Infections and infestations Tonsillitis	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Nervous system disorders Headache	50.0% 6/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Nervous system disorders Somnolence	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
General disorders Influenza like illness	25.0% 3/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
General disorders Chest pain	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
General disorders Application site irritation	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
General disorders Fatigue	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Musculoskeletal and connective tissue disorders Myalgia	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Investigations Laboratory test abnormal	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 2/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Injury, poisoning and procedural complications Fracture	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	20.0% 1/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Injury, poisoning and procedural complications Skin wound	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Injury, poisoning and procedural complications Eye injury	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Skin and subcutaneous tissue disorders Dermatitis atopic	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Vascular disorders Haematoma	0.00% 0/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	16.7% 1/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Eye disorders Conjunctival hyperaemia	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Psychiatric disorders Insomnia	8.3% 1/12 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/5 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.	0.00% 0/6 • from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.

Additional Information

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Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER