Trial Outcomes & Findings for Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery (NCT NCT00846807)
NCT ID: NCT00846807
Last Updated: 2012-09-18
Results Overview
Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected; clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation
Recruitment status
COMPLETED
Target enrollment
5476 participants
Primary outcome timeframe
From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Results posted on
2012-09-18
Participant Flow
There were 5438 patients enrolled, 5292 were treated. Treated patients are presented.
Phase IV, open-label, prospective, observational, single-arm study on surgery patients (hip and knee surgery)
Participant milestones
| Measure |
All Patients
treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
|
|---|---|
|
Overall Study
STARTED
|
5292
|
|
Overall Study
COMPLETED
|
4660
|
|
Overall Study
NOT COMPLETED
|
632
|
Reasons for withdrawal
| Measure |
All Patients
treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
|
|---|---|
|
Overall Study
Adverse Event
|
270
|
|
Overall Study
Lost to Follow-up
|
94
|
|
Overall Study
Withdrawal by Subject
|
56
|
|
Overall Study
Non compliant with European label
|
7
|
|
Overall Study
Switch to other anticoagulants
|
89
|
|
Overall Study
No prescription after hospital discharge
|
56
|
|
Overall Study
Other
|
60
|
Baseline Characteristics
Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery
Baseline characteristics by cohort
| Measure |
All Patients
n=5292 Participants
treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
|
|---|---|
|
Age Continuous
|
62.6 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3061 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2231 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: Treated Set (TS) comprises all patients who completed the surgery and received at least 1 dose of dabigatran etexilate.
Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected; clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation
Outcome measures
| Measure |
All Patients
n=5292 Participants
treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
|
|---|---|
|
Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period
|
0.72 Percentage of participants
95% Confidence Interval 0.51, 0.98 • Interval 0.51 to 0.98
|
PRIMARY outcome
Timeframe: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: TS
The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).
Outcome measures
| Measure |
All Patients
n=5292 Participants
treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
|
|---|---|
|
Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality
|
1.04 Percentage of participants
95% Confidence Interval 0.78 • Interval 0.78 to 1.35
|
SECONDARY outcome
Timeframe: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: TS
Outcome measures
| Measure |
All Patients
n=5292 Participants
treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
|
|---|---|
|
Percentage of Patients With Major Extra-surgical Site Bleedings
|
0.32 Percentage of participants
95% Confidence Interval (0.19, 0.51) • Interval 0.19 to 0.51
|
SECONDARY outcome
Timeframe: From end of surgery (before first dosing) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: TS
Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.
Outcome measures
| Measure |
All Patients
n=4228 Participants
treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
|
|---|---|
|
Volume of Wound Drainage (Post-operative)
|
704.5 ml
Standard Deviation 418.0
|
SECONDARY outcome
Timeframe: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: TS
Outcome measures
| Measure |
All Patients
n=5292 Participants
treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
|
|---|---|
|
Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality
Documented symptomatic proximal DVT
|
0.17 Percentage of participants
95% Confidence Interval (0.08, 0.32) • Interval 0.08 to 0.32
|
|
Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality
Documented symptomatic distal DVT
|
0.87 Percentage of participants
95% Confidence Interval (0.64, 1.16) • Interval 0.64 to 1.16
|
|
Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality
Documented symptomatic non-fatal PE
|
0.09 Percentage of participants
95% Confidence Interval (0.03, 0.22) • Interval 0.03 to 0.22
|
|
Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality
All-cause mortality
|
0.06 Percentage of participants
95% Confidence Interval (0.01, 0,17) • Interval 0.01 to 0.17
|
Adverse Events
All Patients
Serious events: 135 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=5292 participants at risk
treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.08%
4/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Postoperative wound infection
|
0.09%
5/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Cellulitis
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Device related infection
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Diverticulitis
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Groin abscess
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Infection
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Lymphangitis
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Peritoneal infection
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Skin infection
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Staphylococcal infection
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Urinary tract infection
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Infections and infestations
Wound infection
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Blood and lymphatic system disorders
Anaemia
|
0.08%
4/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Blood and lymphatic system disorders
Coagulation factor deficiency
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Immune system disorders
Allergy to metals
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Immune system disorders
Hypersensitivity
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Metabolism and nutrition disorders
Dehydration
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Psychiatric disorders
Confusional state
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Psychiatric disorders
Depression
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Psychiatric disorders
Restlessness
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Nervous system disorders
Cerebrovascular accident
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Nervous system disorders
Monoparesis
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Nervous system disorders
Syncope
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Eye disorders
Retinal haemorrhage
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Eye disorders
Vitreous detachment
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Cardiac disorders
Acute myocardial infarction
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Cardiac disorders
Arrhythmia
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Cardiac disorders
Bradycardia
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Cardiac disorders
Myocardial infarction
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Cardiac disorders
Myocardial ischaemia
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Cardiac disorders
Tachyarrhythmia
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Vascular disorders
Deep vein thrombosis
|
0.17%
9/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Vascular disorders
Haematoma
|
0.13%
7/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Vascular disorders
Haemorrhage
|
0.09%
5/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Vascular disorders
Venous thrombosis
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.15%
8/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.06%
3/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.06%
3/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Anal fissure
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Diarrhoea
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Haematochezia
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Hepatobiliary disorders
Jaundice
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Hepatobiliary disorders
Liver disorder
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.08%
4/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Renal and urinary disorders
Renal failure
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Renal and urinary disorders
Renal failure acute
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Renal and urinary disorders
Urinary retention
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
General disorders
Device dislocation
|
0.15%
8/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
General disorders
Drug ineffective
|
0.15%
8/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
General disorders
Oedema peripheral
|
0.08%
4/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
General disorders
Adverse drug reaction
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
General disorders
Asthenia
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
General disorders
Death
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
General disorders
Pyrexia
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Investigations
Blood glucose increased
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Investigations
Body temperature increased
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Investigations
Haemoglobin decreased
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Investigations
Transaminases increased
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.11%
6/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.06%
3/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.11%
6/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.11%
6/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.09%
5/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Contusion
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Fall
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.02%
1/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
|
Social circumstances
Immobilisation prolonged
|
0.04%
2/5292 • From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
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