Trial Outcomes & Findings for BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery (NCT NCT01225822)

Last Updated: 2014-05-19

Results Overview

Deep vein thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or PE confirmed by objective testing

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1973 participants

Primary outcome timeframe

Treatment period (up to day 8+/-2 days visit)

Results posted on

2014-05-19

Participant Flow

There were 1973 patients enrolled/randomised in this trial but only 1949 started treatment

Participant milestones

Participant milestones
Measure	BIBR 1048 50 mg Bid Dabigatran 50 mg bid(twice daily) oral	BIBR 1048 150 mg Bid Dabigatran 150 mg bid(twice daily) oral	BIBR 1048 225 mg Bid Dabigatran 225 mg bid(twice daily) oral	BIBR 1048 300 mg qd Dabigatran 300 mg qd(once daily) oral	Enoxaparin 40 mg qd Enoxaparin 40 qd (once daily) subcutaneous injection
Overall Study STARTED	389	390	393	385	392
Overall Study COMPLETED	351	334	355	333	361
Overall Study NOT COMPLETED	38	56	38	52	31

Reasons for withdrawal

Reasons for withdrawal
Measure	BIBR 1048 50 mg Bid Dabigatran 50 mg bid(twice daily) oral	BIBR 1048 150 mg Bid Dabigatran 150 mg bid(twice daily) oral	BIBR 1048 225 mg Bid Dabigatran 225 mg bid(twice daily) oral	BIBR 1048 300 mg qd Dabigatran 300 mg qd(once daily) oral	Enoxaparin 40 mg qd Enoxaparin 40 qd (once daily) subcutaneous injection
Overall Study Adverse Event	13	31	18	23	14
Overall Study Protocol Violation	6	8	6	7	4
Overall Study Lost to Follow-up	0	0	0	1	0
Overall Study Withdrawal by Subject	6	7	7	11	6
Overall Study Other	13	10	7	10	7

Baseline Characteristics

BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIBR 1048 50 mg Bid n=389 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=390 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=393 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=385 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=392 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection	Total n=1949 Participants Total of all reporting groups
Age, Customized	66.07 years STANDARD_DEVIATION 10.23 • n=5 Participants	65.86 years STANDARD_DEVIATION 10.77 • n=7 Participants	65.87 years STANDARD_DEVIATION 10.63 • n=5 Participants	66.47 years STANDARD_DEVIATION 10.37 • n=4 Participants	65.03 years STANDARD_DEVIATION 11.03 • n=21 Participants	65.86 years STANDARD_DEVIATION 10.61 • n=8 Participants
Sex: Female, Male Female	223 Participants n=5 Participants	252 Participants n=7 Participants	229 Participants n=5 Participants	246 Participants n=4 Participants	241 Participants n=21 Participants	1191 Participants n=8 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	138 Participants n=7 Participants	164 Participants n=5 Participants	139 Participants n=4 Participants	151 Participants n=21 Participants	758 Participants n=8 Participants

PRIMARY outcome

Timeframe: Treatment period (up to day 8+/-2 days visit)

Population: Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=372 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=375 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=381 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=371 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=382 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection
Number of Participants With Venous Thromboembolic (VTE) Events	86 participants	49 participants	39 participants	47 participants	72 participants

PRIMARY outcome

Timeframe: From approximately 14 days prior to surgery to 4-6 weeks post surgery

Population: Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=389 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=390 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=393 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=385 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=392 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection
Number of Participants With Major Bleeding Events (MBE)	1 participants	16 participants	15 participants	18 participants	8 participants

SECONDARY outcome

Timeframe: Treatment period (up to day 8+/-2 days visit)

Deep venous thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or Pulmonary Embolism (PE) confirmed by objective testing and all deaths.

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=372 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=375 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=381 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=371 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=382 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection
Number of Participants With VTE Events and All Cause Mortality	86 participants	49 participants	39 participants	47 participants	72 participants

SECONDARY outcome

Timeframe: Treatment period (up to day 10)

Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period or PE confirmed by objective testing plus VTE related mortality

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=372 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=375 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=381 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=371 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=382 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection
Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality	15 participants	11 participants	5 participants	6 participants	17 participants

SECONDARY outcome

Timeframe: Treatment period (up to day 8+/-2 days visit)

Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=372 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=375 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=381 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=371 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=382 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection
Number of Participants With Proximal DVT	15 participants	9 participants	5 participants	6 participants	17 participants

SECONDARY outcome

Timeframe: Day 1 (Day of surgery)

Population: Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data

Volume of blood loss was to be analysed using an analysis of variance (ANOVA), which included treatment and centre.

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=389 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=390 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=393 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=385 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=392 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection
Volume of Blood Loss	523.3 ml Standard Deviation 845.8	1538.4 ml Standard Deviation 1474.5	631.4 ml Standard Deviation 720.9	910.3 ml Standard Deviation 918.3	945.5 ml Standard Deviation 651.3

SECONDARY outcome

Timeframe: Day 1 (Day of surgery)

Population: Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data

Percentage of patients requiring transfusions due to bleeding .Rate of need of transfusion were to be analysed using a logistic regression with treatment and centre.

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=389 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=390 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=393 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=385 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=392 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection
Rate of Transfusions Due to Bleedings	0.26 Percentage of patients	5.38 Percentage of patients	4.07 Percentage of patients	4.94 Percentage of patients	3.57 Percentage of patients

SECONDARY outcome

Timeframe: Treatment period (up to day 8+/-2 days visit)

Population: Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data

Number of participants with Clinically Significant, minor or any bleeding events. Clinically significant bleeding events are defined as * Spontaneous skin haematoma larger than \>25 cm² * Wound haematoma \>100 cm² * Spontaneous nose bleed \>5 minutes * Macroscopic haematurea, either spontaneous or lasting more than 24 hours if associated with an intervention * Spontaneous rectal bleeding (more than spot on toilet paper) * Gingival bleeding \>5 minutes * Any other bleeding event considered as clinically significant by the investigator All other bleeding events that did not fulfil the criteria of MBE or clinically significant bleeding event were classified as minor bleeding events.

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=389 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=390 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=393 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=385 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=392 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection
Number of Participants With Clinically Significant, Minor or Any Bleeding Events Clinically significant bleeding events	9 participants	16 participants	20 participants	19 participants	10 participants
Number of Participants With Clinically Significant, Minor or Any Bleeding Events Minor bleeding events	18 participants	31 participants	38 participants	37 participants	25 participants
Number of Participants With Clinically Significant, Minor or Any Bleeding Events Any bleeding events	26 participants	61 participants	65 participants	62 participants	43 participants

SECONDARY outcome

Timeframe: Screening to end of treatment

Population: Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data

Number of patients with possible clinically significant abnormalities, i.e. with values out of normal range. Normal ranges are defined as: Haematocrit \[%\]: (0.35-0.45) for women and (0.39-0.51) for men Haemoglobin \[g/dL\]: (11.6-15.4) for women and (13.2-17.3) for men White Blood Cell count \[10\^9/L\]: (4-10.3) for women and (3.9-10.3) for men Platelets \[10\^9/L\]: (145-420) for women and men Sodium \[mmol/L\]: (135-146) for women and men Potassium \[mmol/L\]: (3.5-5) for women and men Aspartate aminotransferase (AST) \[U/L\]: (11-37) for women and (11-39) for men Alanine aminotransferase (ALT) \[U/L\]: (8-43) for women and (8-45) for men Alkaline Phosphatase \[U/L\]: (36-118) for women and (35-123) for men Creatinine \[mg/dL\]: (0.57-1.06)for women and (0.72-1.3) for men Bilirubin, total \[mg/dL\]: (0.22-1.28) for women and men Uric acid \[mg/dL\]: (2.4-6.47) for women and men

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=389 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=390 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=393 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=385 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=392 Participants Enoxaparin 40 mg qd (once daily) subcutaneous injection
Laboratory Analyses AST increase (N=340,334,344,327,352)	1 participants	0 participants	2 participants	3 participants	9 participants
Laboratory Analyses Alkaline phosphatase incr. (N=340,334,344,327,352)	1 participants	2 participants	0 participants	0 participants	3 participants
Laboratory Analyses Haematocrit decrease (N=325,324,339,320,340)	16 participants	15 participants	14 participants	14 participants	22 participants
Laboratory Analyses Haemoglobin decrease (N=325,324,339,320,340)	122 participants	129 participants	148 participants	129 participants	142 participants
Laboratory Analyses White blood cell ct. decr.(N=325,324,339,320,340)	0 participants	0 participants	2 participants	1 participants	0 participants
Laboratory Analyses Platelets decrease (N=325,324,339,320,340)	0 participants	0 participants	0 participants	0 participants	1 participants
Laboratory Analyses Platelets increase (N=325,324,339,320,340)	0 participants	1 participants	1 participants	0 participants	0 participants
Laboratory Analyses Sodium decrease (N=340,334,344,327,352)	0 participants	2 participants	0 participants	1 participants	0 participants
Laboratory Analyses Potassium decrease (N=340,334,344,326,352)	0 participants	0 participants	1 participants	0 participants	2 participants
Laboratory Analyses Potassium increase (N=340,334,344,326,352)	0 participants	2 participants	1 participants	2 participants	1 participants
Laboratory Analyses ALT increase (N=340,334,344,327,352)	6 participants	5 participants	3 participants	8 participants	20 participants
Laboratory Analyses Creatinine increase (N=340,334,344,327,352)	0 participants	2 participants	0 participants	1 participants	1 participants
Laboratory Analyses Bilirubin, total increase (N=340,334,344,327,352)	0 participants	0 participants	0 participants	1 participants	0 participants
Laboratory Analyses Uric Acid increase (N=340,334,344,327,352)	3 participants	4 participants	4 participants	2 participants	3 participants

SECONDARY outcome

Timeframe: Day 1 to end of treatment

Maximum plasma concentration of Dabigatran (at steady-state) and Pre-dose plasma concentrations at steady state. Cmax represents the maximum concentration of Dabigatran in plasma. Cmax,ss represents the maximum concentration of Dabigatran in plasma at steady state. Cpre,ss represents pre-dose concentration of Dabigatran in plasma at steady state

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=365 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=358 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=365 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=351 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd Enoxaparin 40 mg qd (once daily) subcutaneous injection
Plasma Concentration (Cmax) of Dabigatran Cmax (N=88, 83, 84, 96, 0)	24.5 ng/mL Geometric Coefficient of Variation 115	60.5 ng/mL Geometric Coefficient of Variation 97.3	79.9 ng/mL Geometric Coefficient of Variation 94.7	132 ng/mL Geometric Coefficient of Variation 81.6	—
Plasma Concentration (Cmax) of Dabigatran Cmax at steady-state (N=87, 74, 79, 85, 0)	48.0 ng/mL Geometric Coefficient of Variation 64.6	165 ng/mL Geometric Coefficient of Variation 63.6	257 ng/mL Geometric Coefficient of Variation 62.7	271 ng/mL Geometric Coefficient of Variation 75.2	—
Plasma Concentration (Cmax) of Dabigatran Cpre at steady-state	19.6 ng/mL Geometric Coefficient of Variation 70.7	70.3 ng/mL Geometric Coefficient of Variation 87.3	113 ng/mL Geometric Coefficient of Variation 80.9	38.0 ng/mL Geometric Coefficient of Variation 85.9	—

SECONDARY outcome

Timeframe: up to day 8+/-2 days visit

Area under the plasma concentration-time curve during a dosing interval (at steady-state). The AUC0-12h (for b.i.d. treatment regimens) and AUC0-24h (300 mg q.d.) after the first dose on day of surgery calculated by extrapolation using the elimination rate constant, reported only if the extrapolated fraction of AUC was less than 30 % of the total AUC.

Outcome measures

Outcome measures
Measure	BIBR 1048 50 mg Bid n=69 Participants Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=54 Participants Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=62 Participants Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=76 Participants Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd Enoxaparin 40 mg qd (once daily) subcutaneous injection
Area Under the Plasma Concentration-time Curve During a Dosing Interval AUC during a dosing interval (N=13,12,21,72,0)	229 ng*h/mL Geometric Coefficient of Variation 88.1	636 ng*h/mL Geometric Coefficient of Variation 56.2	605 ng*h/mL Geometric Coefficient of Variation 91.6	1610 ng*h/mL Geometric Coefficient of Variation 82.5	—
Area Under the Plasma Concentration-time Curve During a Dosing Interval AUC during a dosing interval at steady-state	350 ng*h/mL Geometric Coefficient of Variation 66.8	1250 ng*h/mL Geometric Coefficient of Variation 64.8	1910 ng*h/mL Geometric Coefficient of Variation 64.9	2450 ng*h/mL Geometric Coefficient of Variation 76.1	—

Adverse Events

BIBR 1048 50 mg Bid

Serious events: 25 serious events

Other events: 242 other events

Deaths: 0 deaths

BIBR 1048 150 mg Bid

Serious events: 29 serious events

Other events: 267 other events

Deaths: 0 deaths

BIBR 1048 225 mg Bid

Serious events: 21 serious events

Other events: 256 other events

Deaths: 0 deaths

BIBR 1048 300 mg qd

Serious events: 33 serious events

Other events: 267 other events

Deaths: 0 deaths

Enoxaparin 40 mg qd

Serious events: 31 serious events

Other events: 258 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BIBR 1048 50 mg Bid n=389 participants at risk Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=390 participants at risk Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=393 participants at risk Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=385 participants at risk Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=392 participants at risk Enoxaparin 40 mg qd (once daily) subcutaneous injection
Gastrointestinal disorders Abdominal pain NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Post procedural drainage	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Blood and lymphatic system disorders Haemolytic anaemia NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Blood and lymphatic system disorders Hypocoagulable state	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Blood and lymphatic system disorders Leukopenia NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Acute myocardial infarction	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Atrial fibrillation	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Bradycardia NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.51% 2/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Cardiac arrest	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Cardiac disorder NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Cardiac failure chronic	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Cardiogenic shock	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Coronary artery occlusion	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Myocardial infarction	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Cardiac disorders Myocardial ischaemia	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Ear and labyrinth disorders Vertigo	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Diverticulitis intestinal haemorrhagic	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.51% 2/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Gastric ulcer	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Gastroduodenal ulcer	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Gastrointestinal haemorrhage NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Haematemesis	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Melaena	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Peritonitis	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.52% 2/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Small intestinal obstruction NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Subileus	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Chest pain	0.51% 2/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Fall	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Fatigue	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Hyperpyrexia	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Impaired healing	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Inflammation localised	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Oedema lower limb	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Pyrexia	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.52% 2/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Rigors	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Arthritis infective NOS	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.51% 2/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Bronchopneumonia NOS	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Cystitis NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Erysipelas	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Gastroenteritis NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Haematoma infection	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Implant infection	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Meningitis NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Pneumonia NOS	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Post-operative wound infection	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.52% 2/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Infections and infestations Wound infection NEC	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.76% 3/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.78% 3/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.77% 3/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Dislocation of joint prosthesis	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.52% 2/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Face injury	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Femur fracture NOS	0.51% 2/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Haemothorax	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Intraoperative haemorrhage	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Joint dislocation NEC	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.77% 3/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.78% 3/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Joint dislocation postoperative	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Joint ligament rupture	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.51% 2/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.78% 3/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Post procedural pain	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.52% 2/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Postoperative haematoma	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Procedural site reaction	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.52% 2/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Investigations Blood alkaline phosphatase NOS increased	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Investigations Haemoglobin decreased	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Musculoskeletal and connective tissue disorders Bone disorder NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Musculoskeletal and connective tissue disorders Pain in limb	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis aggravated	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm NOS	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Nervous system disorders Epilepsy NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Nervous system disorders Ischaemic stroke NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Nervous system disorders Paraesthesia	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Nervous system disorders Peripheral neuropathy NOS	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Nervous system disorders Radiculitis NOS	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Nervous system disorders Transient ischaemic attack	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Psychiatric disorders Confusion	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Renal and urinary disorders Anuria	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Renal and urinary disorders Haematuria	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Renal and urinary disorders Renal failure aggravated	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Renal and urinary disorders Urinary incontinence	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Renal and urinary disorders Urinary retention	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Respiratory, thoracic and mediastinal disorders Dyspnoea NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Skin and subcutaneous tissue disorders Face oedema	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Arterial haemorrhage NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Deep venous thrombosis NOS	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.77% 3/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Haematoma NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Haemorrhage NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Hypotension NOS	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Hypovolaemic shock	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Pulmonary embolism	0.26% 1/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.77% 3/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Venous thrombosis deep limb	1.3% 5/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.51% 2/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Wound haemorrhage	0.00% 0/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.25% 1/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.26% 1/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	0.00% 0/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.

Other adverse events

Other adverse events
Measure	BIBR 1048 50 mg Bid n=389 participants at risk Dabigatran 50 mg bid (twice daily) oral	BIBR 1048 150 mg Bid n=390 participants at risk Dabigatran 150 mg bid (twice daily) oral	BIBR 1048 225 mg Bid n=393 participants at risk Dabigatran 225 mg bid (twice daily) oral	BIBR 1048 300 mg qd n=385 participants at risk Dabigatran 300 mg qd (once daily) oral	Enoxaparin 40 mg qd n=392 participants at risk Enoxaparin 40 mg qd (once daily) subcutaneous injection
Blood and lymphatic system disorders Anaemia NOS	5.9% 23/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	6.7% 26/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	6.9% 27/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.7% 22/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.6% 18/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Constipation	8.5% 33/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	9.7% 38/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	8.7% 34/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	11.9% 46/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	8.7% 34/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Nausea	21.6% 84/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	26.9% 105/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	23.4% 92/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	27.3% 105/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	28.3% 111/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Gastrointestinal disorders Vomiting NOS	19.5% 76/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	19.7% 77/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	19.1% 75/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	19.7% 76/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	16.8% 66/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
General disorders Pyrexia	8.5% 33/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	7.7% 30/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	9.2% 36/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	9.1% 35/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	8.2% 32/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Post procedural drainage	3.1% 12/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.1% 16/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.9% 23/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.7% 18/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	2.0% 8/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.5% 6/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	3.6% 14/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	1.5% 6/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.7% 18/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.1% 20/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Injury, poisoning and procedural complications Wound secretion	3.9% 15/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.4% 21/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.1% 16/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.4% 17/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	1.5% 6/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Investigations Haemoglobin decreased	3.3% 13/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.6% 18/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.3% 21/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	3.9% 15/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.4% 21/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Nervous system disorders Headache NOS	4.9% 19/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	3.8% 15/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.1% 16/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	2.6% 10/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.1% 20/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Psychiatric disorders Insomnia	15.2% 59/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	11.5% 45/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	13.2% 52/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	15.3% 59/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	13.0% 51/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Haematoma NOS	2.6% 10/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.4% 17/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.3% 21/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	3.6% 14/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	1.3% 5/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Hypotension NOS	4.9% 19/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	6.4% 25/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.3% 21/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.5% 21/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	5.1% 20/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.
Vascular disorders Venous thrombosis deep limb	8.5% 33/389 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	3.1% 12/390 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	3.3% 13/393 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	3.1% 12/385 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.	4.1% 16/392 • 14 days +/- 2 days Time frame is from first dose of randomised treatment up to the end of treatment including 6 days after last intake.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER