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Trial record 1 of 1 for:    re-verse-ad
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Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02104947
First Posted: April 7, 2014
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: July 21, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hemorrhage
Intervention: Drug: idarucizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Idarucizumab (Group A) Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Idarucizumab (Group B) Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.

Participant Flow:   Overall Study
    Idarucizumab (Group A)   Idarucizumab (Group B)
STARTED   301   202 
COMPLETED   222   146 
NOT COMPLETED   79   56 
Withdrawal by Subject                10                3 
Lost to Follow-up                4                4 
Protocol Violation                6                8 
Adverse Event                57                38 
Other than stated above                2                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set: Treated Set is defined as all patients who were administered idarucizumab.

Reporting Groups
  Description
Idarucizumab (Group A) Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Idarucizumab (Group B) Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Total Total of all reporting groups

Baseline Measures
   Idarucizumab (Group A)   Idarucizumab (Group B)   Total 
Overall Participants Analyzed 
[Units: Participants]
 301   202   503 
Age 
[Units: Years]
Mean (Standard Deviation)
 77.1  (10.4)   75.9  (10.5)   76.6  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      129  42.9%      100  49.5%      229  45.5% 
Male      172  57.1%      102  50.5%      274  54.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT   [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]

2.  Secondary:   Reversal of aPTT and TT From Central Laboratory   [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]

3.  Secondary:   Duration of Reversal   [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]

4.  Secondary:   Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively   [ Time Frame: within 24 hours of surgery ]

5.  Secondary:   Time to Cessation of Bleeding (for Group A Only)   [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]

6.  Secondary:   Cmin,1 of Unbound Sum (Free) Dabigatran   [ Time Frame: Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial ]

7.  Secondary:   Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial   [ Time Frame: after the first vial of idarucizumab and before the start of second vial on Day1 ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame From the first vial of idarucizumab until end of study (90 ± 7 days after the second vial).
Additional Description No text entered.

Reporting Groups
  Description
Idarucizumab (Group A) Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Idarucizumab (Group B) Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.

Serious Adverse Events
    Idarucizumab (Group A)   Idarucizumab (Group B)
Total, Serious Adverse Events     
# participants affected / at risk   160/301 (53.16%)   106/202 (52.48%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Disseminated intravascular coagulation † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Haemorrhagic anaemia † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Hypocoagulable state † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Normochromic normocytic anaemia † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Pancytopenia † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Cardiac disorders     
Acute myocardial infarction † 1     
# participants affected / at risk   1/301 (0.33%)   2/202 (0.99%) 
Angina unstable † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Atrial fibrillation † 1     
# participants affected / at risk   2/301 (0.66%)   1/202 (0.50%) 
Atrial flutter † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Atrial tachycardia † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Atrial thrombosis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Bradycardia † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Cardiac amyloidosis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Cardiac arrest † 1     
# participants affected / at risk   1/301 (0.33%)   9/202 (4.46%) 
Cardiac failure † 1     
# participants affected / at risk   11/301 (3.65%)   4/202 (1.98%) 
Cardiac failure acute † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Cardiac failure chronic † 1     
# participants affected / at risk   3/301 (1.00%)   0/202 (0.00%) 
Cardiac failure congestive † 1     
# participants affected / at risk   10/301 (3.32%)   2/202 (0.99%) 
Cardiac tamponade † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Cardio-respiratory arrest † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Cardiogenic shock † 1     
# participants affected / at risk   1/301 (0.33%)   2/202 (0.99%) 
Coronary artery disease † 1     
# participants affected / at risk   0/301 (0.00%)   2/202 (0.99%) 
Mitral valve incompetence † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Myocardial infarction † 1     
# participants affected / at risk   3/301 (1.00%)   1/202 (0.50%) 
Myocardial ischaemia † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Pericardial effusion † 1     
# participants affected / at risk   0/301 (0.00%)   2/202 (0.99%) 
Pulseless electrical activity † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Right ventricular failure † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Ventricular fibrillation † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Ventricular tachycardia † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Endocrine disorders     
Thyroid haemorrhage † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Eye disorders     
Amaurosis fugax † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Vitreous floaters † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Gastrointestinal disorders     
Abdominal wall haematoma † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Anal haemorrhage † 1     
# participants affected / at risk   2/301 (0.66%)   0/202 (0.00%) 
Erosive duodenitis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Gastric haemorrhage † 1     
# participants affected / at risk   0/301 (0.00%)   2/202 (0.99%) 
Gastric ulcer † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Gastrointestinal haemorrhage † 1     
# participants affected / at risk   4/301 (1.33%)   2/202 (0.99%) 
Gastrointestinal mucosal necrosis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Gastrointestinal necrosis † 1     
# participants affected / at risk   1/301 (0.33%)   2/202 (0.99%) 
Gastrointestinal perforation † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Ileal ulcer † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Ileus paralytic † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Intestinal haemorrhage † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Intestinal ischaemia † 1     
# participants affected / at risk   1/301 (0.33%)   2/202 (0.99%) 
Intestinal obstruction † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Intestinal perforation † 1     
# participants affected / at risk   0/301 (0.00%)   2/202 (0.99%) 
Lower gastrointestinal haemorrhage † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Mallory-Weiss syndrome † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Melaena † 1     
# participants affected / at risk   2/301 (0.66%)   1/202 (0.50%) 
Pancreatitis † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Pancreatitis necrotising † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Proctitis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Rectal haemorrhage † 1     
# participants affected / at risk   2/301 (0.66%)   1/202 (0.50%) 
Small intestinal obstruction † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Vomiting † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
General disorders     
Adhesion † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Asthenia † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Chest pain † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
General physical health deterioration † 1     
# participants affected / at risk   2/301 (0.66%)   2/202 (0.99%) 
Multiple organ dysfunction syndrome † 1     
# participants affected / at risk   2/301 (0.66%)   4/202 (1.98%) 
Oedema peripheral † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Pyrexia † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Sudden cardiac death † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Sudden death † 1     
# participants affected / at risk   2/301 (0.66%)   0/202 (0.00%) 
Hepatobiliary disorders     
Cholecystitis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Cholestasis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Hepatic cirrhosis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Hepatic function abnormal † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Ischaemic hepatitis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Immune system disorders     
Anaphylactic reaction † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Anaphylactic shock † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Infections and infestations     
Abdominal sepsis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Abscess limb † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Bronchitis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Campylobacter gastroenteritis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Cellulitis † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Clostridium difficile colitis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Enterococcal sepsis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Erysipelas † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Escherichia bacteraemia † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Escherichia sepsis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Escherichia urinary tract infection † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
H1N1 influenza † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Infection † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Infectious pleural effusion † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Influenza † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Liver abscess † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Mediastinitis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Medical device site joint infection † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Oesophageal candidiasis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Osteomyelitis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Peritonitis † 1     
# participants affected / at risk   0/301 (0.00%)   2/202 (0.99%) 
Pneumonia † 1     
# participants affected / at risk   14/301 (4.65%)   7/202 (3.47%) 
Pneumonia bacterial † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Postoperative wound infection † 1     
# participants affected / at risk   0/301 (0.00%)   2/202 (0.99%) 
Pyelonephritis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Respiratory tract infection † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Sepsis † 1     
# participants affected / at risk   7/301 (2.33%)   5/202 (2.48%) 
Septic shock † 1     
# participants affected / at risk   2/301 (0.66%)   11/202 (5.45%) 
Urinary tract infection † 1     
# participants affected / at risk   6/301 (1.99%)   0/202 (0.00%) 
Urosepsis † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Injury, poisoning and procedural complications     
Brain contusion † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Cystitis radiation † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Fall † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Femoral neck fracture † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Femur fracture † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Graft thrombosis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Head injury † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Joint dislocation † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Periprosthetic fracture † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Post procedural complication † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Postoperative ileus † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Procedural haemorrhage † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Spinal compression fracture † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Stoma site irritation † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Subdural haematoma † 1     
# participants affected / at risk   9/301 (2.99%)   0/202 (0.00%) 
Subdural haemorrhage † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Traumatic haematoma † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Traumatic haemothorax † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Vascular pseudoaneurysm † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Wound haemorrhage † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Investigations     
Alanine aminotransferase increased † 1     
# participants affected / at risk   2/301 (0.66%)   0/202 (0.00%) 
Aspartate aminotransferase increased † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Blood bilirubin increased † 1     
# participants affected / at risk   2/301 (0.66%)   0/202 (0.00%) 
Haemoglobin decreased † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Metabolism and nutrition disorders     
Electrolyte imbalance † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Gout † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Hyperkalaemia † 1     
# participants affected / at risk   2/301 (0.66%)   1/202 (0.50%) 
Hyponatraemia † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Starvation † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Rhabdomyolysis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Tenosynovitis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon † 1     
# participants affected / at risk   3/301 (1.00%)   1/202 (0.50%) 
Basal cell carcinoma † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Bile duct cancer † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Bronchial carcinoma † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Cervix carcinoma † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Colon cancer † 1     
# participants affected / at risk   2/301 (0.66%)   0/202 (0.00%) 
Colon neoplasm † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Diffuse large B-cell lymphoma † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Genital neoplasm malignant female † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Intestinal adenocarcinoma † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Malignant neoplasm progression † 1     
# participants affected / at risk   2/301 (0.66%)   1/202 (0.50%) 
Malignant pleural effusion † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Meningioma † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Neoplasm progression † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Pancreatic carcinoma † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Plasma cell myeloma † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Prostate cancer metastatic † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Rectal adenocarcinoma † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Nervous system disorders     
Basal ganglia haemorrhage † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Brain injury † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Brain oedema † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Brain stem haemorrhage † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Brain stem syndrome † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Cerebellar syndrome † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Cerebral haemorrhage † 1     
# participants affected / at risk   2/301 (0.66%)   0/202 (0.00%) 
Cerebral infarction † 1     
# participants affected / at risk   2/301 (0.66%)   1/202 (0.50%) 
Cerebrovascular accident † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Chorea † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Dementia † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Depressed level of consciousness † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Embolic cerebral infarction † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Encephalopathy † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Epilepsy † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Haemorrhage intracranial † 1     
# participants affected / at risk   5/301 (1.66%)   1/202 (0.50%) 
Headache † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Intracranial mass † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Ischaemic stroke † 1     
# participants affected / at risk   5/301 (1.66%)   2/202 (0.99%) 
Monoplegia † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Paraplegia † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Parkinson's disease † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Seizure † 1     
# participants affected / at risk   2/301 (0.66%)   1/202 (0.50%) 
Simple partial seizures † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Syncope † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Product Issues     
Device loosening † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Psychiatric disorders     
Delirium † 1     
# participants affected / at risk   13/301 (4.32%)   8/202 (3.96%) 
Hallucinations, mixed † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Mental status changes † 1     
# participants affected / at risk   2/301 (0.66%)   1/202 (0.50%) 
Renal and urinary disorders     
Acute kidney injury † 1     
# participants affected / at risk   5/301 (1.66%)   6/202 (2.97%) 
Anuria † 1     
# participants affected / at risk   3/301 (1.00%)   0/202 (0.00%) 
Chronic kidney disease † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Hydronephrosis † 1     
# participants affected / at risk   0/301 (0.00%)   3/202 (1.49%) 
Renal failure † 1     
# participants affected / at risk   1/301 (0.33%)   5/202 (2.48%) 
Renal haemorrhage † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Urinary retention † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Acute respiratory failure † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Apnoea † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Cough † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Dysphonia † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Hypoxia † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Pleural effusion † 1     
# participants affected / at risk   4/301 (1.33%)   3/202 (1.49%) 
Pneumonia aspiration † 1     
# participants affected / at risk   2/301 (0.66%)   0/202 (0.00%) 
Pneumonitis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Pneumothorax † 1     
# participants affected / at risk   0/301 (0.00%)   2/202 (0.99%) 
Pulmonary embolism † 1     
# participants affected / at risk   5/301 (1.66%)   4/202 (1.98%) 
Pulmonary fibrosis † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Pulmonary haemorrhage † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Pulmonary hypertension † 1     
# participants affected / at risk   2/301 (0.66%)   0/202 (0.00%) 
Pulmonary oedema † 1     
# participants affected / at risk   7/301 (2.33%)   3/202 (1.49%) 
Respiratory arrest † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Respiratory failure † 1     
# participants affected / at risk   7/301 (2.33%)   4/202 (1.98%) 
Skin and subcutaneous tissue disorders     
Skin necrosis † 1     
# participants affected / at risk   0/301 (0.00%)   2/202 (0.99%) 
Subcutaneous emphysema † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Vascular disorders     
Aortic aneurysm rupture † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Circulatory collapse † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Deep vein thrombosis † 1     
# participants affected / at risk   7/301 (2.33%)   3/202 (1.49%) 
Haematoma † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Hypertensive crisis † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Hypotension † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Peripheral arterial occlusive disease † 1     
# participants affected / at risk   1/301 (0.33%)   0/202 (0.00%) 
Peripheral embolism † 1     
# participants affected / at risk   0/301 (0.00%)   1/202 (0.50%) 
Peripheral ischaemia † 1     
# participants affected / at risk   1/301 (0.33%)   2/202 (0.99%) 
Shock † 1     
# participants affected / at risk   0/301 (0.00%)   2/202 (0.99%) 
Shock haemorrhagic † 1     
# participants affected / at risk   1/301 (0.33%)   1/202 (0.50%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 19.1




  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02104947     History of Changes
Other Study ID Numbers: 1321.3
2013-004813-41 ( EudraCT Number: EudraCT )
First Submitted: April 2, 2014
First Posted: April 7, 2014
Results First Submitted: July 21, 2017
Results First Posted: August 18, 2017
Last Update Posted: October 3, 2017