Trial Outcomes & Findings for Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study) (NCT NCT00786474)
NCT ID: NCT00786474
Last Updated: 2016-03-07
Results Overview
The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1884 participants
Primary outcome timeframe
from subject signing of the consent until completed the study (Day -30 to Day +37)
Results posted on
2016-03-07
Participant Flow
6585 subjects were screened. 4701 were excluded, 1884 subjects enrolled and underwent randomization.
Participant milestones
| Measure |
Placebo
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
|
Dalteparin
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
950
|
934
|
|
Overall Study
COMPLETED
|
913
|
891
|
|
Overall Study
NOT COMPLETED
|
37
|
43
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
|
Dalteparin
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
|
|---|---|---|
|
Overall Study
Death
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
23
|
31
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Other
|
4
|
4
|
Baseline Characteristics
Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)
Baseline characteristics by cohort
| Measure |
Placebo
n=950 Participants
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
|
Dalteparin
n=934 Participants
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
|
Total
n=1884 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 8.88 • n=7 Participants
|
71.7 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
254 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
502 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
696 Participants
n=5 Participants
|
686 Participants
n=7 Participants
|
1382 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
860 participants
n=5 Participants
|
849 participants
n=7 Participants
|
1709 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Nonwhite
|
88 participants
n=5 Participants
|
82 participants
n=7 Participants
|
170 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from subject signing of the consent until completed the study (Day -30 to Day +37)Population: Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.
The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated
Outcome measures
| Measure |
Placebo
n=918 Participants
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
|
Dalteparin
n=895 Participants
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
|
|---|---|---|
|
Number of Arterial Thromboembolic Events
Stroke
|
2 Arterial thromboembolic events
|
3 Arterial thromboembolic events
|
|
Number of Arterial Thromboembolic Events
Transient Ischemic Attack
|
2 Arterial thromboembolic events
|
0 Arterial thromboembolic events
|
|
Number of Arterial Thromboembolic Events
Systemic embolism
|
0 Arterial thromboembolic events
|
0 Arterial thromboembolic events
|
PRIMARY outcome
Timeframe: from subject signing of the consent until completed the study (Day -30 to Day +37)Population: Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.
Major bleeding is defined as symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death
Outcome measures
| Measure |
Placebo
n=918 Participants
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
|
Dalteparin
n=895 Participants
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
|
|---|---|---|
|
Major Bleeding
|
12 participants
|
29 participants
|
SECONDARY outcome
Timeframe: from subject signing of the consent until completed the study (Day -30 to Day +37)Population: Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.
Outcome measures
| Measure |
Placebo
n=918 Participants
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
|
Dalteparin
n=895 Participants
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
|
|---|---|---|
|
Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism
Death
|
5 participants
|
4 participants
|
|
Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism
Myocardial infarction
|
7 participants
|
14 participants
|
|
Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism
Deep-vein thrombosis
|
0 participants
|
1 participants
|
|
Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism
pulmonary embolism
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: from subject signing of the consent until completed the study (Day -30 to Day +37)Population: Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data
Minor bleeding is defined as symptomatic or clinically-overt bleeding that does not satisfy the criteria for major bleeding
Outcome measures
| Measure |
Placebo
n=918 Participants
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
|
Dalteparin
n=895 Participants
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
|
|---|---|---|
|
Number of Participants With Minor Bleeding
|
110 participants
|
187 participants
|
Adverse Events
Placebo
Serious events: 66 serious events
Other events: 0 other events
Deaths: 0 deaths
Dalteparin
Serious events: 133 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=950 participants at risk
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
|
Dalteparin
n=934 participants at risk
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
|
|---|---|---|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Bradycardia
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Cardiac Failure
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.42%
4/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.54%
5/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Myocardial Infarction
|
0.21%
2/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.21%
2/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Pericarditis
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.21%
2/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Endocrine disorders
Adrenal Haemorrhage
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Ascites
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Dysphagia
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Blood and lymphatic system disorders
Hypocoagulable State
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.32%
3/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Angina Pectoris
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Atrial Fibrillation
|
0.21%
2/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.32%
3/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Cardiac disorders
Atrial Flutter
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.43%
4/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Ileus
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Pancreatic Haemorrhage
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.64%
6/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
General disorders
Cardiac Death
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
General disorders
Chest Pain
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
General disorders
Influenza Like Illness
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
General disorders
Multi-Organ Failure
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
General disorders
Non-Cardiac Chest Pain
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
General disorders
Oedema Peripheral
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
General disorders
Pyrexia
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
General disorders
Cholangitis
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Hepatobiliary disorders
Gallbladder Fistula
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Hepatobiliary disorders
Arthritis Bacterial
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Arthritis Infective
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Bronchitis
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Cellulitis
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.21%
2/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Gastroenteritis
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Infection
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Influenza
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Perirectal Abscess
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Peritonsillar Abscess
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Pneumonia
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.54%
5/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Postoperative Wound Infection
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Sepsis
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.21%
2/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Urinary Tract Infection
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.21%
2/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Infections and infestations
Urosepsis
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Fall
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Incision Site Haemorrhage
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.54%
5/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.32%
3/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.43%
4/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Splenic Rupture
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Urinary Retention Postoperative
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Injury, poisoning and procedural complications
Vaginal Laceration
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Investigations
Blood Culture Positive
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Investigations
Electrocardiogram Qt Prolonged
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Investigations
Haemoglobin Decreased
|
0.21%
2/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Metabolism and nutrition disorders
Hyperosmolar State
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Haemorrhage
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Of Colon
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Adenocarcinoma
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.32%
3/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Nervous system disorders
Dizziness
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Nervous system disorders
Embolic Stroke
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Nervous system disorders
Ischaemic Stroke
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Nervous system disorders
Migraine
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Nervous system disorders
Presyncope
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Nervous system disorders
Syncope
|
0.32%
3/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.21%
2/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.21%
2/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Psychiatric disorders
Delirium
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Renal and urinary disorders
Haematuria
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.54%
5/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Renal and urinary disorders
Urethral Obstruction
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Renal and urinary disorders
Urinary Bladder Rupture
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Renal and urinary disorders
Urinary Retention
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.00%
0/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.21%
2/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.32%
3/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.21%
2/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.21%
2/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Vascular disorders
Haematoma
|
0.11%
1/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.11%
1/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
|
Vascular disorders
Hypotension
|
0.00%
0/950 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
0.21%
2/934 • from subject signing of the consent until completed the study from Day -30 to Day +37
Study only collected and reported serious adverse events
|
Other adverse events
Adverse event data not reported
Additional Information
Thomas Ortel, MD, PhD, Principal Investigator
Duke University Medical Center
Phone: 919-684-5350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place