Trial Outcomes & Findings for Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA (NCT NCT01139658)
NCT ID: NCT01139658
Last Updated: 2014-01-16
Results Overview
Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).
Recruitment status
COMPLETED
Target enrollment
1676 participants
Primary outcome timeframe
11 weeks
Results posted on
2014-01-16
Participant Flow
Participant milestones
| Measure |
Total Knee Replacement
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Overall Study
STARTED
|
747
|
929
|
|
Overall Study
COMPLETED
|
691
|
816
|
|
Overall Study
NOT COMPLETED
|
56
|
113
|
Reasons for withdrawal
| Measure |
Total Knee Replacement
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
27
|
|
Overall Study
Lack of Efficacy
|
15
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
No documentation of treatment
|
1
|
0
|
|
Overall Study
Other
|
28
|
75
|
Baseline Characteristics
Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
Baseline characteristics by cohort
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total
n=1675 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.8 years
STANDARD_DEVIATION 9.5 • n=93 Participants
|
67.8 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
68.69 years
STANDARD_DEVIATION 10.78 • n=27 Participants
|
|
Sex: Female, Male
Female
|
497 Participants
n=93 Participants
|
494 Participants
n=4 Participants
|
991 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
249 Participants
n=93 Participants
|
435 Participants
n=4 Participants
|
684 Participants
n=27 Participants
|
|
Creatinine clearance
|
86.4 mL/min
STANDARD_DEVIATION 29.6 • n=93 Participants
|
85.1 mL/min
STANDARD_DEVIATION 31.9 • n=4 Participants
|
85.7 mL/min
STANDARD_DEVIATION 30.9 • n=27 Participants
|
|
Weight
|
79.6 kilogramm
STANDARD_DEVIATION 16.3 • n=93 Participants
|
74.5 kilogramm
STANDARD_DEVIATION 15.6 • n=4 Participants
|
76.8 kilogramm
STANDARD_DEVIATION 15.9 • n=27 Participants
|
|
Height
|
164.6 cm
STANDARD_DEVIATION 9.1 • n=93 Participants
|
166.8 cm
STANDARD_DEVIATION 9.1 • n=4 Participants
|
165.8 cm
STANDARD_DEVIATION 9.1 • n=27 Participants
|
|
Participants with a Alanine Aminotransferase (ALT) of >2x normal upper limit
|
29 participants
n=93 Participants
|
40 participants
n=4 Participants
|
69 participants
n=27 Participants
|
|
Participants with at least one thromboembolic risk factor
|
151 participants
n=93 Participants
|
145 participants
n=4 Participants
|
296 participants
n=27 Participants
|
|
Participants with at least one cardiovascular risk factor
|
543 participants
n=93 Participants
|
586 participants
n=4 Participants
|
1129 participants
n=27 Participants
|
|
Participants with at least one concomitant disease
|
176 participants
n=93 Participants
|
203 participants
n=4 Participants
|
379 participants
n=27 Participants
|
|
Previous treatment
NSAID
|
402 participants
n=93 Participants
|
509 participants
n=4 Participants
|
911 participants
n=27 Participants
|
|
Previous treatment
Aspirin
|
83 participants
n=93 Participants
|
79 participants
n=4 Participants
|
162 participants
n=27 Participants
|
|
Previous treatment
Clopidogrel
|
12 participants
n=93 Participants
|
15 participants
n=4 Participants
|
27 participants
n=27 Participants
|
|
Previous treatment
Amiodarone
|
7 participants
n=93 Participants
|
7 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Previous treatment
Hydroquindin
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Previous treatment
Verapimil
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Current treatment
NSAID
|
92 participants
n=93 Participants
|
125 participants
n=4 Participants
|
217 participants
n=27 Participants
|
|
Current treatment
Aspirin
|
56 participants
n=93 Participants
|
45 participants
n=4 Participants
|
101 participants
n=27 Participants
|
|
Current treatment
Clopidogrel
|
5 participants
n=93 Participants
|
3 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Current treatment
Amiodarone
|
7 participants
n=93 Participants
|
7 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Current treatment
Hydroquinidin
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Current treatment
Verapamil
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Type of orthopedic surgery
|
746 participants
n=93 Participants
|
929 participants
n=4 Participants
|
1675 participants
n=27 Participants
|
|
Indication for the surgery
Osteoarthritis
|
701 participants
n=93 Participants
|
818 participants
n=4 Participants
|
1519 participants
n=27 Participants
|
|
Indication for the surgery
Repair of existing prothesis
|
24 participants
n=93 Participants
|
42 participants
n=4 Participants
|
66 participants
n=27 Participants
|
|
Indication for the surgery
Osteonecrosis
|
7 participants
n=93 Participants
|
30 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
Indication for the surgery
Post-trauma
|
6 participants
n=93 Participants
|
19 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
Indication for the surgery
Inflammatory arthritis
|
6 participants
n=93 Participants
|
10 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Indication for the surgery
Other
|
2 participants
n=93 Participants
|
9 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Duration of the surgery
|
80.8 minutes
STANDARD_DEVIATION 27.5 • n=93 Participants
|
70.1 minutes
STANDARD_DEVIATION 28.6 • n=4 Participants
|
74.9 minutes
STANDARD_DEVIATION 28.1 • n=27 Participants
|
|
Type of anesthesia
General
|
463 participants
n=93 Participants
|
742 participants
n=4 Participants
|
1205 participants
n=27 Participants
|
|
Type of anesthesia
Spinal
|
281 participants
n=93 Participants
|
187 participants
n=4 Participants
|
468 participants
n=27 Participants
|
|
Type of anesthesia
Epidural
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Occurrence of Symptomatic Venous Thromboembolic Events
|
19 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation. a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE).
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Occurrence of Major Bleeding Events
|
8 participants
|
16 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Dosage of Pradaxa at Initiation
75 mg/day
|
142 participants
|
162 participants
|
|
Dosage of Pradaxa at Initiation
110 mg/day
|
394 participants
|
417 participants
|
|
Dosage of Pradaxa at Initiation
150 mg/day
|
80 participants
|
122 participants
|
|
Dosage of Pradaxa at Initiation
220mg/day
|
130 participants
|
228 participants
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Duration Between Surgery and First Dose of Pradaxa
|
12.6 hours
Standard Deviation 14.5
|
14.6 hours
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Duration of Treatment
|
27.5 days
Standard Deviation 11.8
|
33.3 days
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Proportion of Patients With a Preoperative ALT Measurement
|
73.3 percentage of participants
|
74.5 percentage of participants
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
The adherence to treatment was measured by patient declaration.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Adherence to Treatment
|
98.6 percent
Standard Deviation 24.6
|
97.3 percent
Standard Deviation 24.6
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Concomitant treatments prescribed at hospital discharge.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Concomitant Treatments
NSAID
|
150 participants
|
143 participants
|
|
Concomitant Treatments
Aspirin
|
79 participants
|
61 participants
|
|
Concomitant Treatments
Clopidogrel
|
9 participants
|
8 participants
|
|
Concomitant Treatments
Amiodarone
|
7 participants
|
6 participants
|
|
Concomitant Treatments
Hydroquinidin
|
0 participants
|
0 participants
|
|
Concomitant Treatments
Verapamil
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 11 weeksTreated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Number of Patients Who Switched to Another Anticoagulant Therapy
|
43 participants
|
45 participants
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge
|
24 participants
|
44 participants
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge
|
420 participants
|
584 participants
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Reasons for Nurse Visits on the Day of Hospital Discharge
Wound dressing care
|
366 participants
|
510 participants
|
|
Reasons for Nurse Visits on the Day of Hospital Discharge
Blood sample for platelet count
|
27 participants
|
69 participants
|
|
Reasons for Nurse Visits on the Day of Hospital Discharge
Other care
|
29 participants
|
54 participants
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Frequency of Nurse Visits on the Day of Hospital Discharge
Blood sample for platelet count
|
1.7 times per week
Standard Deviation 0.5
|
1.7 times per week
Standard Deviation 0.5
|
|
Frequency of Nurse Visits on the Day of Hospital Discharge
Wound dressing care
|
2.3 times per week
Standard Deviation 0.9
|
2.5 times per week
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: Outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 11 weeksPopulation: Outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 11 weeksPopulation: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Outcome measures
| Measure |
Total Knee Replacement
n=746 Participants
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 Participants
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Reasons for Usual Follow-up
Re-hospitalization
|
11 participants
|
17 participants
|
|
Reasons for Usual Follow-up
Consultation in the context of usual follow-up
|
201 participants
|
292 participants
|
|
Reasons for Usual Follow-up
Consultation outside the context of usual follow-u
|
19 participants
|
28 participants
|
Adverse Events
Total Knee Replacement
Serious events: 48 serious events
Other events: 0 other events
Deaths: 0 deaths
Total Hip Replacement
Serious events: 37 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Total Knee Replacement
n=746 participants at risk
Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
Total Hip Replacement
n=929 participants at risk
Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.27%
2/746 • 11 weeks
|
0.22%
2/929 • 11 weeks
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.54%
4/746 • 11 weeks
|
0.32%
3/929 • 11 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.13%
1/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.13%
1/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
General disorders
Asthenia
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
General disorders
Death
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
General disorders
Device dislocation
|
0.13%
1/746 • 11 weeks
|
0.22%
2/929 • 11 weeks
|
|
General disorders
Impaired healing
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
General disorders
Malaise
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Infections and infestations
Device related infection
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Infections and infestations
Device related sepsis
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Infections and infestations
Infection
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Infections and infestations
Septic shock
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.40%
3/746 • 11 weeks
|
0.32%
3/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/746 • 11 weeks
|
0.43%
4/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation postoperative
|
0.00%
0/746 • 11 weeks
|
0.43%
4/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.27%
2/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.40%
3/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Renal and urinary disorders
Micturition disorder
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/746 • 11 weeks
|
0.22%
2/929 • 11 weeks
|
|
Surgical and medical procedures
Patellectomy
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
2.3%
17/746 • 11 weeks
|
0.65%
6/929 • 11 weeks
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/746 • 11 weeks
|
0.22%
2/929 • 11 weeks
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Vascular disorders
Haemorrhage
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Vascular disorders
Phlebitis
|
0.40%
3/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Vascular disorders
Phlebitis deep
|
0.13%
1/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Vascular disorders
Pulmonary embolism
|
0.54%
4/746 • 11 weeks
|
0.22%
2/929 • 11 weeks
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Vascular disorders
Thrombosis
|
0.13%
1/746 • 11 weeks
|
0.00%
0/929 • 11 weeks
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/746 • 11 weeks
|
0.11%
1/929 • 11 weeks
|
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