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Trial record 62 of 230 for:    warfarin AND International

Secondary Prevention of Venous Thrombo Embolism (VTE). (RE-MEDY)

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ClinicalTrials.gov Identifier: NCT00329238
Recruitment Status : Completed
First Posted : May 24, 2006
Results First Posted : September 14, 2011
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Thromboembolism
Interventions Drug: Dabigatran
Drug: Warfarin
Enrollment 2867
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0
Period Title: Overall Study
Started 1430 [1] 1426 [1]
Completed 1154 1145
Not Completed 276 281
Reason Not Completed
Adverse Event             147             129
Protocol Violation             23             34
Lost to Follow-up             2             6
Withdrawal by Subject             64             58
Other reason (not specified)             40             54
[1]
2866 were randomized. A total of ten did not receive treatment resulting in 2856 starting study.
Arm/Group Title Dabigatran Warfarin Total
Hide Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0 Total of all reporting groups
Overall Number of Baseline Participants 1430 1426 2856
Hide Baseline Analysis Population Description
The FAS consisted of all randomised patients who were documented to have taken at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1430 participants 1426 participants 2856 participants
55.38  (14.99) 53.90  (15.34) 54.64  (15.18)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1430 participants 1426 participants 2856 participants
>=18 to <40 years 237 269 506
>=40 to <50 years 250 291 541
>=50 to <65 years 500 459 959
>=65 to <75 years 303 288 591
>= 75 years 140 119 259
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1430 participants 1426 participants 2856 participants
Female
559
  39.1%
555
  38.9%
1114
  39.0%
Male
871
  60.9%
871
  61.1%
1742
  61.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1430 participants 1426 participants 2856 participants
Not Hispanic/Latino 1325 1317 2642
Hispanic/Latino 105 109 214
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1430 participants 1426 participants 2856 participants
White 1288 1284 2572
Black 29 28 57
Asian 113 114 227
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 1430 participants 1426 participants 2856 participants
171.55  (9.73) 171.95  (10.08) 171.75  (9.90)
[1]
Measure Description: N = 1429, 1424, 2853
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 1430 participants 1426 participants 2856 participants
86.09  (19.26) 85.95  (18.87) 86.02  (19.06)
[1]
Measure Description: N = 1429, 1422, 2851
Weight category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1430 participants 1426 participants 2856 participants
< 50 kg 10 5 15
>= 50 to < 100 kg 1120 1117 2237
>= 100 kg 299 300 599
Missing 1 4 5
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/square meter
Number Analyzed 1430 participants 1426 participants 2856 participants
29.15  (5.65) 29.01  (5.75) 29.08  (5.70)
[1]
Measure Description: N = 1428, 1422, 2850
Body Mass Index (BMI) category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1430 participants 1426 participants 2856 participants
<25 kg/square meter 315 334 649
>=25 to <30 kg/square meter 571 584 1155
>=30 to <35 kg/square meter 356 330 686
>= 35 kg/square meter 186 174 360
Missing 2 4 6
Smoking history  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1430 participants 1426 participants 2856 participants
Non-smoker 814 829 1643
Ex-smoker 393 366 759
Current smoker 223 231 454
Serum creatinine clearance   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 1430 participants 1426 participants 2856 participants
104.2  (38.6) 106.6  (37.9) 105.4  (38.3)
[1]
Measure Description: N = 1418, 1410, 2828
Serum creatinine clearance category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1430 participants 1426 participants 2856 participants
>=0 to <30 mL/min 0 4 4
>=30 to <50 mL/min 59 45 104
>=50 to <80 mL/min 328 289 617
>= 80 mL/min 1031 1072 2103
Missing 12 16 28
1.Primary Outcome
Title Composite of Recurrent VTE or VTE Death at 36 Months
Hide Description Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 26 18
Number of participants with no event 1404 1408
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.
Statistical Test of Hypothesis P-Value 0.0137
Comments p-value for non-inferiority. The non-inferiority margin for the hazard ratio was chosen to be 2.85.
Method Regression, Cox
Comments HR within cohort estimated by Cox regr. with treatment and baseline stratific. factor. Overall HR calc. by pooling with inverse variance weighting.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.44
Confidence Interval 95%
0.78 to 2.64
Estimation Comments HR for time to first recurrent VTE or VTE death.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2424
Comments p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the hazard ratio was then compared with 1 to evaluate the superiority claim of dabigatran over warfarin.
Method Regression, Cox
Comments [Not Specified]
2.Primary Outcome
Title Composite of Recurrent VTE or VTE Death at 18 Months
Hide Description Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 22 17
Number of participants with no event 1408 1409
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value for non-inferiority. The non-inferiority margin for the risk difference was chosen to be 2.80.
Method Regression, Cox
Comments Risk difference for time to first recurrent VTE/VTE death is calculated based on weighted KM estimates across the cohorts via meta-analysis approach.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.38
Confidence Interval 95%
-0.50 to 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4013
Comments p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the risk difference was then compared with 0 to evaluate the superiority claim of dabigatran over warfarin.
Method Kaplan-Meier
Comments [Not Specified]
3.Secondary Outcome
Title Composite of Recurrent VTE or All Cause Death at 36 Months
Hide Description Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 42 36
Number of participants with no event 1388 1390
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4732
Comments [Not Specified]
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval 95%
0.75 to 1.84
Estimation Comments HR for time to first centrally adjudicated recurrent VTE or all cause death.
4.Secondary Outcome
Title Composite of Recurrent VTE or All Cause Death at 18 Months
Hide Description Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 36 32
Number of participants with no event 1394 1394
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8876
Comments [Not Specified]
Method Kaplan-Meier
Comments Risk difference for the time to first centrally adjudicated recurrent VTE or all cause death at month 18.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.09
Confidence Interval 95%
-1.11 to 1.28
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Deep Vein Thrombosis (DVT) at 36 Months
Hide Description Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 17 13
Number of participants with no event 1413 1413
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4548
Comments [Not Specified]
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.32
Confidence Interval 95%
0.64 to 2.71
Estimation Comments HR for time to first centrally adjudicated recurrent symptomatic DVT
6.Secondary Outcome
Title DVT at 18 Months
Hide Description Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 15 12
Number of participants with no event 1415 1414
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6563
Comments [Not Specified]
Method Kaplan-Meier
Comments Risk difference for the time to first centrally adjudicated recurrent symptomatic DVT at Month 18.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.19
Confidence Interval 95%
-0.63 to 1.00
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Symptomatic Pulmonary Embolism (PE) at 36 Months
Hide Description Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 10 5
Number of participants with no event 1420 1421
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1925
Comments [Not Specified]
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.04
Confidence Interval 95%
0.70 to 5.98
Estimation Comments Hazard ratio for time to first centrally adjudicated recurrent symptomatic PE.
8.Secondary Outcome
Title Symptomatic Pulmonary Embolism (PE) at 18 Months
Hide Description Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 8 5
Number of participants with no event 1422 1421
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3723
Comments [Not Specified]
Method Kaplan-Meier
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.26
Confidence Interval 95%
-0.32 to 0.84
Estimation Comments Risk difference for the time to first centrally adjudicated recurrent symptomatic PE at Month 18
9.Secondary Outcome
Title Deaths Related to VTE at 36 Months
Hide Description Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 1 1
Number of participants with no event 1429 1425
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9921
Comments [Not Specified]
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval 95%
0.06 to 16.22
Estimation Comments Hazard ratio for time to deaths related to VTE.
10.Secondary Outcome
Title Deaths Related to VTE at 18 Months
Hide Description Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 1 1
Number of participants with no event 1429 1425
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9204
Comments [Not Specified]
Method Kaplan-Meier
Comments Risk difference for the time to deaths related to VTE at Month 18.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.01
Confidence Interval 95%
-0.20 to 0.23
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Deaths of All Causes at 36 Months
Hide Description Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 17 19
Number of participants with no event 1413 1407
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7405
Comments [Not Specified]
Method Regression, Cox
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval 95%
0.47 to 1.72
Estimation Comments Hazard ratio for time to all deaths
12.Secondary Outcome
Title Deaths of All Causes at 18 Months
Hide Description Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: Participants
Number of participants with event 15 16
Number of participants with no event 1415 1410
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Dabigatran versus Warfarin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9622
Comments [Not Specified]
Method Kaplan-Meier
Comments Risk difference for the time to all deaths at Month 18.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.02
Confidence Interval 95%
-0.89 to 0.84
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With Bleeding Events
Hide Description

MBE (major bleeding event) if it fulfilled at least one of the following criteria

  • Fatal bleeding
  • Symptomatic bleeding in a critical area or organ.
  • Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.

Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs

CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria

  • Spontaneous skin haematoma ≥25 cm2
  • Spontaneous nose bleed >5 min duration
  • Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h
  • Spontaneous rectal bleeding
  • Gingival bleeding >5 min
  • Bleeding leading to hospitalisation or requiring surgical treatment
  • Bleeding leading to a transfusion of <2 units of whole blood or red cells
  • Any other bleeding event considered clinically relevant by the investigator
Time Frame first intake of study drug until 6 days following last intake of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
FAS as treated
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1426
Measure Type: Number
Unit of Measure: participants
patients with MBE 13 25
patients with MBE and /or CRBE 80 145
patients with any bleeding event 277 373
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0577
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.52
Confidence Interval 95%
0.27 to 1.02
Estimation Comments This is the analysis of the time to the first MBE.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.61 to 0.83
Estimation Comments This is the analysis of the time to the first occurrence of any bleeding event.
14.Secondary Outcome
Title Laboratory Analysis
Hide Description Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).
Time Frame 18 months + 30 days follow up
Hide Outcome Measure Data
Hide Analysis Population Description
FAS as treated
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1411 1402
Measure Type: Number
Unit of Measure: participants
ALT increase 26 30
AST increase 23 23
Alkaline phosphatase 9 14
Total bilirubin 9 8
15.Secondary Outcome
Title Number of Participants With Definite Acute Coronary Syndrome (ACS)
Hide Description All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.
Time Frame day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS as treated
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
150 mg twice daily, total daily dose 300 mg
Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Number of Participants Analyzed 1430 1415
Measure Type: Number
Unit of Measure: participants
During intake of study drug, N=1430 , N=1415 12 2
After stopping study drug, N=1426, N=1400 1 5
Time Frame 18-month treatment period
Adverse Event Reporting Description 30-day follow-up period subsequent to the completion of treatment
 
Arm/Group Title Dabigatran Warfarin Post Dabigatran Post Warfarin
Hide Arm/Group Description 150 mg twice daily, total daily dose 300 mg Target International Normalized Ratio (INR) of 2.0 to 3.0 [Not Specified] [Not Specified]
All-Cause Mortality
Dabigatran Warfarin Post Dabigatran Post Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Warfarin Post Dabigatran Post Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   227/1430 (15.87%)   224/1426 (15.71%)   33/1395 (2.37%)   41/1384 (2.96%) 
Blood and lymphatic system disorders         
Anaemia  1  3/1430 (0.21%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Anaemia megaloblastic  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Haemorrhagic anaemia  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Iron deficiency anaemia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Neutropenia  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Splenic infarction  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cardiac disorders         
Acute coronary syndrome  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Acute left ventricular failure  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Acute myocardial infarction  1  4/1430 (0.28%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Angina pectoris  1  2/1430 (0.14%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Angina unstable  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Atrial fibrillation  1  4/1430 (0.28%)  4/1426 (0.28%)  0/1395 (0.00%)  0/1384 (0.00%) 
Atrial flutter  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Atrial tachycardia  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cardiac arrest  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cardiac asthma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cardiac failure  1  1/1430 (0.07%)  0/1426 (0.00%)  2/1395 (0.14%)  0/1384 (0.00%) 
Cardiac failure chronic  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cardiac failure congestive  1  1/1430 (0.07%)  3/1426 (0.21%)  0/1395 (0.00%)  1/1384 (0.07%) 
Cardio-respiratory arrest  1  1/1430 (0.07%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Cardiogenic shock  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cardiomegaly  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cardiomyopathy  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cardiopulmonary failure  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Congestive cardiomyopathy  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cor pulmonale  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Coronary artery disease  1  2/1430 (0.14%)  1/1426 (0.07%)  1/1395 (0.07%)  0/1384 (0.00%) 
Coronary artery occlusion  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Coronary artery stenosis  1  3/1430 (0.21%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Left ventricular failure  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Myocardial infarction  1  6/1430 (0.42%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Myocardial ischaemia  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  1/1384 (0.07%) 
Palpitations  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Supraventricular tachycardia  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Tachycardia  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Ventricular tachycardia  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Congenital, familial and genetic disorders         
Metabolic myopathy  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vitello-intestinal duct remnant  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Ear and labyrinth disorders         
Hypoacusis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vertigo  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Endocrine disorders         
Goitre  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Eye disorders         
Cataract  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Diabetic retinopathy  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Diplopia  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Retinal detachment  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Retinal vascular thrombosis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Trichiasis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vitreous haemorrhage  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  1/1384 (0.07%) 
Gastrointestinal disorders         
Abdominal hernia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Abdominal hernia obstructive  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Abdominal pain  1  4/1430 (0.28%)  8/1426 (0.56%)  1/1395 (0.07%)  0/1384 (0.00%) 
Abdominal pain lower  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Abdominal pain upper  1  1/1430 (0.07%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Acute abdomen  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Colitis ischaemic  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Colonic polyp  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Constipation  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Diarrhoea  1  2/1430 (0.14%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Diverticular perforation  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Diverticulum intestinal haemorrhagic  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Duodenal ulcer  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Duodenitis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Faecal incontinence  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Faecal vomiting  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Gastric polyps  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gastric ulcer  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gastritis  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Gastritis erosive  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gastrointestinal haemorrhage  1  1/1430 (0.07%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gastrointestinal hypomotility  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gastrointestinal pain  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gastrooesophageal reflux disease  1  2/1430 (0.14%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gingival bleeding  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hernial eventration  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hiatus hernia  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Ileus  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Inguinal hernia  1  4/1430 (0.28%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Intestinal obstruction  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Intestinal polyp  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Intestinal strangulation  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Large intestine perforation  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Mallory-Weiss syndrome  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Melaena  1  0/1430 (0.00%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Mouth ulceration  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Nausea  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  1/1384 (0.07%) 
Pancreatitis acute  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pancreatitis chronic  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pancreatitis relapsing  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Peptic ulcer haemorrhage  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Peritoneal haematoma  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Peritoneal haemorrhage  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Peritonitis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pneumoperitoneum  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Rectal haemorrhage  1  4/1430 (0.28%)  2/1426 (0.14%)  0/1395 (0.00%)  1/1384 (0.07%) 
Reflux oesophagitis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Retroperitoneal haemorrhage  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Small intestinal haemorrhage  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Subileus  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Umbilical hernia  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Umbilical hernia, obstructive  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/1430 (0.07%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vomiting  1  2/1430 (0.14%)  4/1426 (0.28%)  1/1395 (0.07%)  0/1384 (0.00%) 
General disorders         
Adverse drug reaction  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Asthenia  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Chest discomfort  1  4/1430 (0.28%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Chest pain  1  4/1430 (0.28%)  9/1426 (0.63%)  0/1395 (0.00%)  2/1384 (0.14%) 
Death  1  0/1430 (0.00%)  1/1426 (0.07%)  1/1395 (0.07%)  0/1384 (0.00%) 
Device breakage  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Device occlusion  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Diapedesis  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Facial pain  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Fatigue  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
General physical health deterioration  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hernia  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hypothermia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Inflammation  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Mass  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Non-cardiac chest pain  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Oedema  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Oedema peripheral  1  1/1430 (0.07%)  4/1426 (0.28%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pain  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pyrexia  1  1/1430 (0.07%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Sudden death  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hepatobiliary disorders         
Bile duct stone  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cholangitis  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Cholecystitis  1  1/1430 (0.07%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cholecystitis acute  1  3/1430 (0.21%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Cholecystitis chronic  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cholelithiasis  1  1/1430 (0.07%)  3/1426 (0.21%)  1/1395 (0.07%)  1/1384 (0.07%) 
Chronic hepatitis  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Hepatic steatosis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Jaundice cholestatic  1  1/1430 (0.07%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Immune system disorders         
Hypersensitivity  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Infections and infestations         
Abdominal abscess  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Appendicitis  1  0/1430 (0.00%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Bacteraemia  1  0/1430 (0.00%)  1/1426 (0.07%)  1/1395 (0.07%)  0/1384 (0.00%) 
Bronchiolitis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Bronchitis  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Bronchopneumonia  1  1/1430 (0.07%)  1/1426 (0.07%)  1/1395 (0.07%)  0/1384 (0.00%) 
Cellulitis  1  3/1430 (0.21%)  5/1426 (0.35%)  1/1395 (0.07%)  0/1384 (0.00%) 
Diverticulitis  1  2/1430 (0.14%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Endometritis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Erysipelas  1  3/1430 (0.21%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gangrene  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Gingival abscess  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gnathostomiasis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Infected skin ulcer  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Infection  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Liver abscess  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Lobar pneumonia  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Lower respiratory tract infection  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Lung infection  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Lymphangitis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Meningococcal sepsis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Necrotising fasciitis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Oral herpes  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Otitis externa  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pneumonia  1  6/1430 (0.42%)  5/1426 (0.35%)  0/1395 (0.00%)  1/1384 (0.07%) 
Pneumonia staphylococcal  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Pneumonia viral  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Postoperative wound infection  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Pulpitis dental  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Purulence  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Purulent discharge  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pyelonephritis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Rectal abscess  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Respiratory tract infection  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Scrotal abscess  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Sepsis  1  3/1430 (0.21%)  1/1426 (0.07%)  0/1395 (0.00%)  3/1384 (0.22%) 
Septic shock  1  0/1430 (0.00%)  0/1426 (0.00%)  2/1395 (0.14%)  0/1384 (0.00%) 
Sinusitis  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Tooth infection  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Urinary tract infection  1  2/1430 (0.14%)  3/1426 (0.21%)  1/1395 (0.07%)  0/1384 (0.00%) 
Urosepsis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Viral infection  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Wound infection  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Injury, poisoning and procedural complications         
Accidental drug intake by child  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Acetabulum fracture  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Ankle fracture  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Chemical peritonitis  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Chest injury  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Concussion  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Contusion  1  0/1430 (0.00%)  2/1426 (0.14%)  1/1395 (0.07%)  0/1384 (0.00%) 
Drug exposure during pregnancy  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Eye injury  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Face injury  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Fall  1  4/1430 (0.28%)  4/1426 (0.28%)  1/1395 (0.07%)  2/1384 (0.14%) 
Femoral neck fracture  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Femur fracture  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Fibula fracture  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Foot fracture  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hand fracture  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hip fracture  1  2/1430 (0.14%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Humerus fracture  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Incisional hernia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Injury  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Joint injury  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Limb traumatic amputation  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Lower limb fracture  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Meniscus lesion  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Overdose  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Periorbital haematoma  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Perirenal haematoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Post procedural haemorrhage  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Radius fracture  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Renal haematoma  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Road traffic accident  1  2/1430 (0.14%)  4/1426 (0.28%)  0/1395 (0.00%)  0/1384 (0.00%) 
Skin laceration  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Spinal cord injury  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Splenic rupture  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Stab wound  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Subdural haematoma  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Subdural haemorrhage  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Tibia fracture  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Upper limb fracture  1  0/1430 (0.00%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vascular graft occlusion  1  1/1430 (0.07%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Wound  1  0/1430 (0.00%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Wound dehiscence  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Wound haemorrhage  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Wound secretion  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Investigations         
Alanine aminotransferase increased  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Arteriogram coronary normal  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Aspartate aminotransferase increased  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Blood creatinine increased  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Body temperature increased  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Coagulation time prolonged  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gamma-glutamyltransferase increased  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hepatic enzyme increased  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
International normalised ratio increased  1  1/1430 (0.07%)  4/1426 (0.28%)  0/1395 (0.00%)  0/1384 (0.00%) 
Weight decreased  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  2/1430 (0.14%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Diabetes mellitus  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Diabetes mellitus inadequate control  1  2/1430 (0.14%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hyperglycaemia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hyperlipidaemia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hypoproteinaemia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Musculoskeletal and connective tissue disorders         
Amyotrophy  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Arthralgia  1  2/1430 (0.14%)  4/1426 (0.28%)  0/1395 (0.00%)  0/1384 (0.00%) 
Arthritis  1  1/1430 (0.07%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Back pain  1  2/1430 (0.14%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Bone pain  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Costochondritis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Foot deformity  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Haemarthrosis  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Intervertebral disc protrusion  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Muscle haemorrhage  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Muscular weakness  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Musculoskeletal chest pain  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Myalgia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Neck pain  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Osteoarthritis  1  2/1430 (0.14%)  4/1426 (0.28%)  1/1395 (0.07%)  0/1384 (0.00%) 
Pain in extremity  1  2/1430 (0.14%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pain in jaw  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Periostitis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pseudarthrosis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Rheumatoid arthritis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Rotator cuff syndrome  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Sacroiliitis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Sensation of heaviness  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Spinal column stenosis  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Spinal disorder  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Spinal osteoarthritis  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Spondylitis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Adenocarcinoma pancreas  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
B-cell lymphoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Basal cell carcinoma  1  3/1430 (0.21%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Bile duct cancer  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Bladder cancer  1  2/1430 (0.14%)  2/1426 (0.14%)  2/1395 (0.14%)  0/1384 (0.00%) 
Bone cancer metastatic  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Brain neoplasm  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Breast cancer  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  2/1384 (0.14%) 
Cervix carcinoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Chondrosarcoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Colon cancer  1  2/1430 (0.14%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Colon neoplasm  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Endometrial cancer  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gastric cancer  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gastric neoplasm  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Gastrointestinal cancer metastatic  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hepatic neoplasm  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hepatic neoplasm malignant  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Large intestine carcinoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Laryngeal cancer  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Liposarcoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Lung cancer metastatic  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Lung neoplasm malignant  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Lung squamous cell carcinoma stage unspecified  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Malignant ascites  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Malignant melanoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Malignant neoplasm progression  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metastases to bladder  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metastases to bone  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metastases to central nervous system  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metastases to liver  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metastases to lung  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metastases to lymph nodes  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metastases to meninges  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metastases to peritoneum  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Metastases to retroperitoneum  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metastasis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Morton's neuroma  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Myelodysplastic syndrome  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Neoplasm  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Neoplasm malignant  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Non-Hodgkin's lymphoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Oesophageal carcinoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Omentum neoplasm  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Ovarian cancer  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Ovarian cancer recurrent  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Pancreatic carcinoma  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pancreatic carcinoma metastatic  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pancreatic neoplasm  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Penis carcinoma  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Prostate cancer  1  5/1430 (0.35%)  7/1426 (0.49%)  1/1395 (0.07%)  0/1384 (0.00%) 
Prostate cancer metastatic  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Prostatic adenoma  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Rectal cancer  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Renal cancer  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Sarcoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Skin cancer  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Squamous cell carcinoma  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Thyroid cancer  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Transitional cell carcinoma  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Tumour invasion  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Uterine leiomyoma  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Nervous system disorders         
Brain stem stroke  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Carotid artery dissection  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Carpal tunnel syndrome  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cerebral haematoma  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cerebral haemorrhage  1  2/1430 (0.14%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cerebral infarction  1  0/1430 (0.00%)  1/1426 (0.07%)  1/1395 (0.07%)  0/1384 (0.00%) 
Cerebral thrombosis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cerebrovascular accident  1  2/1430 (0.14%)  2/1426 (0.14%)  0/1395 (0.00%)  1/1384 (0.07%) 
Cognitive disorder  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Coma  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Convulsion  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Diabetic encephalopathy  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Diabetic neuropathy  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Dizziness  1  2/1430 (0.14%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Epilepsy  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Facial neuralgia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Guillain-Barre syndrome  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Headache  1  2/1430 (0.14%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hemiparesis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hypoxic-ischaemic encephalopathy  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Intercostal neuralgia  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Ischaemic stroke  1  3/1430 (0.21%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Lacunar infarction  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Loss of consciousness  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Motor dysfunction  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Multiple sclerosis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Parkinson's disease  1  1/1430 (0.07%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Presyncope  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Sciatica  1  2/1430 (0.14%)  0/1426 (0.00%)  3/1395 (0.22%)  0/1384 (0.00%) 
Sensory disturbance  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Sensory loss  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Syncope  1  4/1430 (0.28%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Transient ischaemic attack  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
VIIth nerve paralysis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vascular encephalopathy  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Eclampsia  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Ectopic pregnancy  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Psychiatric disorders         
Bipolar disorder  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Completed suicide  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Depression  1  3/1430 (0.21%)  2/1426 (0.14%)  1/1395 (0.07%)  0/1384 (0.00%) 
Mental disorder  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Suicide attempt  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Renal and urinary disorders         
Calculus ureteric  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Dysuria  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Haematuria  1  2/1430 (0.14%)  6/1426 (0.42%)  2/1395 (0.14%)  0/1384 (0.00%) 
Hydronephrosis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Nephrolithiasis  1  2/1430 (0.14%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Nephropathy  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Nephrotic syndrome  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pollakiuria  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Renal artery stenosis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Renal colic  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Renal failure  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Renal failure acute  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Renal haemorrhage  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Renal infarct  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Urinary bladder haemorrhage  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Urinary bladder polyp  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Urinary incontinence  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Urinary retention  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  2/1430 (0.14%)  4/1426 (0.28%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cervical dysplasia  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Endometriosis  1  0/1430 (0.00%)  1/1426 (0.07%)  1/1395 (0.07%)  0/1384 (0.00%) 
Epididymal enlargement  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Menometrorrhagia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Menorrhagia  1  0/1430 (0.00%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Metrorrhagia  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Ovarian cyst  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Prostatitis  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Uterine polyp  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vaginal discharge  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vaginal haemorrhage  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Alveolitis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Asthma  1  3/1430 (0.21%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Chronic obstructive pulmonary disease  1  2/1430 (0.14%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Cough  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Dyspnoea  1  5/1430 (0.35%)  3/1426 (0.21%)  0/1395 (0.00%)  1/1384 (0.07%) 
Eosinophilic pneumonia  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Epistaxis  1  0/1430 (0.00%)  3/1426 (0.21%)  0/1395 (0.00%)  0/1384 (0.00%) 
Haemoptysis  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  1/1384 (0.07%) 
Lung disorder  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pleural effusion  1  0/1430 (0.00%)  1/1426 (0.07%)  1/1395 (0.07%)  0/1384 (0.00%) 
Pneumonitis  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Pulmonary embolism  1  9/1430 (0.63%)  3/1426 (0.21%)  3/1395 (0.22%)  2/1384 (0.14%) 
Pulmonary fibrosis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pulmonary hypertension  1  3/1430 (0.21%)  1/1426 (0.07%)  1/1395 (0.07%)  0/1384 (0.00%) 
Pulmonary oedema  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Respiratory arrest  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Respiratory disorder  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Respiratory failure  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  1/1384 (0.07%) 
Skin and subcutaneous tissue disorders         
Haemorrhage subcutaneous  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hyperhidrosis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Neurodermatitis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Panniculitis  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Pruritus  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Rash  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Skin ulcer  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Urticaria  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vascular purpura  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Surgical and medical procedures         
Abortion induced  1  1/1430 (0.07%)  2/1426 (0.14%)  2/1395 (0.14%)  1/1384 (0.07%) 
Colostomy closure  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Femoral hernia repair  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Finger amputation  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hip arthroplasty  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Incisional hernia repair  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Joint arthroplasty  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Knee arthroplasty  1  0/1430 (0.00%)  2/1426 (0.14%)  0/1395 (0.00%)  0/1384 (0.00%) 
Rotator cuff repair  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Tooth extraction  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Vascular disorders         
Aneurysm ruptured  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Aortic aneurysm  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Aortic dissection  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Arterial insufficiency  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Arterial thrombosis limb  1  1/1430 (0.07%)  0/1426 (0.00%)  1/1395 (0.07%)  1/1384 (0.07%) 
Arteriosclerosis  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Circulatory collapse  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Deep vein thrombosis  1  10/1430 (0.70%)  6/1426 (0.42%)  1/1395 (0.07%)  2/1384 (0.14%) 
Haematoma  1  0/1430 (0.00%)  3/1426 (0.21%)  0/1395 (0.00%)  1/1384 (0.07%) 
Haemorrhage  1  1/1430 (0.07%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hypertension  1  2/1430 (0.14%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hypotension  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Hypovolaemic shock  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Lymphoedema  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Peripheral arterial occlusive disease  1  0/1430 (0.00%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Peripheral artery aneurysm  1  0/1430 (0.00%)  1/1426 (0.07%)  0/1395 (0.00%)  0/1384 (0.00%) 
Peripheral embolism  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Peripheral ischaemia  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Phlebitis  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Post thrombotic syndrome  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Shock  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Thrombophlebitis superficial  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Thrombosis  1  2/1430 (0.14%)  0/1426 (0.00%)  1/1395 (0.07%)  0/1384 (0.00%) 
Varicose ulceration  1  0/1430 (0.00%)  0/1426 (0.00%)  0/1395 (0.00%)  1/1384 (0.07%) 
Varicose vein  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Venous insufficiency  1  1/1430 (0.07%)  0/1426 (0.00%)  0/1395 (0.00%)  0/1384 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Warfarin Post Dabigatran Post Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   409/1430 (28.60%)   415/1426 (29.10%)   34/1395 (2.44%)   32/1384 (2.31%) 
Gastrointestinal disorders         
Diarrhoea  1  73/1430 (5.10%)  51/1426 (3.58%)  4/1395 (0.29%)  3/1384 (0.22%) 
General disorders         
Oedema peripheral  1  76/1430 (5.31%)  68/1426 (4.77%)  8/1395 (0.57%)  3/1384 (0.22%) 
Infections and infestations         
Influenza  1  75/1430 (5.24%)  67/1426 (4.70%)  2/1395 (0.14%)  11/1384 (0.79%) 
Nasopharyngitis  1  112/1430 (7.83%)  127/1426 (8.91%)  5/1395 (0.36%)  8/1384 (0.58%) 
Musculoskeletal and connective tissue disorders         
Pain in extremity  1  109/1430 (7.62%)  110/1426 (7.71%)  9/1395 (0.65%)  6/1384 (0.43%) 
Nervous system disorders         
Headache  1  84/1430 (5.87%)  100/1426 (7.01%)  4/1395 (0.29%)  8/1384 (0.58%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  46/1430 (3.22%)  92/1426 (6.45%)  7/1395 (0.50%)  3/1384 (0.22%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00329238     History of Changes
Other Study ID Numbers: 1160.47
2005-002536-94 ( EudraCT Number: EudraCT )
First Submitted: May 23, 2006
First Posted: May 24, 2006
Results First Submitted: August 10, 2011
Results First Posted: September 14, 2011
Last Update Posted: May 19, 2014