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A Phase III Study of Apixaban in Patients With Atrial Fibrillation (AVERROES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00496769
First received: July 2, 2007
Last updated: March 1, 2016
Last verified: March 2016
Results First Received: August 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Atrial Fibrillation
Interventions: Drug: Apixaban
Drug: Acetylsalicylic acid

  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
A total 6421 patients were enrolled in the study. Of these, 5598 were randomized (2807 to apixaban and 2791 to acetylsalicylic acid). Most (435) of the patients who were not randomized (823) no longer met study criteria. Of those randomized, 5578 received treatment (2798 with apixaban, and 2780 with acetylsalicylic acid).

Reporting Groups
  Description
Apixaban, 2.5 or 5 mg Twice Daily Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
Acetylsalicylic Acid, 81-324 mg Once Daily Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion

Participant Flow:   Overall Study
    Apixaban, 2.5 or 5 mg Twice Daily   Acetylsalicylic Acid, 81-324 mg Once Daily
STARTED   2807 [1]   2791 [1] 
Received Treatment   2798   2708 
COMPLETED   2249   2142 
NOT COMPLETED   558   649 
>=1 reason assigned per patient                558                649 
[1] Randomized



  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.
No text entered.

Reporting Groups
  Description
Apixaban, 2.5 or 5 mg Twice Daily Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
Acetylsalicylic Acid, 81-324 mg Once Daily Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
Total Total of all reporting groups

Baseline Measures
   Apixaban, 2.5 or 5 mg Twice Daily   Acetylsalicylic Acid, 81-324 mg Once Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 2807   2791   5598 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.7  (9.44)   70.0  (9.71)   69.9  (9.58) 
Age, Customized 
[Units: Participants]
     
< 65 years   855   865   1720 
>=65 but <75 years   1049   938   1987 
>=75 years   903   988   1891 
Gender 
[Units: Participants]
     
Female   1147   1174   2321 
Male   1660   1617   3277 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   6   6   12 
Asian   541   544   1085 
Native Hawaiian or Other Pacific Islander   3   1   4 
Black or African American   10   26   36 
White   2221   2178   4399 
Other   26   36   62 
Number of Participants by Number of Risk Factors for Stroke 
[Units: Participants]
     
1 or fewer   1085   1077   2162 
2 or more   1722   1714   3436 
Number of Participants With Risk Factors for Stroke [1] 
[Units: Participants]
     
Age of 75 years or older   903   988   1891 
Prior stroke or transient ischemic attack   390   374   764 
Heart failure (NYHA class ≥2) or LVEF ≤35%   961   926   1887 
Diabetes mellitus   536   559   1095 
Hypertension requiring pharmacologic treatment   2408   2429   4837 
Peripheral artery disease   66   78   144 
[1] NYHA=New York Health Authority; LVEF=left ventricular ejection fraction


  Outcome Measures
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1.  Primary:   Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period   [ Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ]

2.  Primary:   Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period   [ Time Frame: Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ]

3.  Secondary:   Event Rates of Major Vascular Events (Stroke/Systemic Embolism, Myocardial Infarction, Death) in the Intended-treatment Period   [ Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ]

4.  Secondary:   Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period   [ Time Frame: First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010 ]

5.  Secondary:   Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome   [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ]

6.  Secondary:   Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality   [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ]

7.  Secondary:   Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)   [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ]

8.  Secondary:   Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)   [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ]

9.  Secondary:   Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death   [ Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ]


  Serious Adverse Events
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Reporting Groups
  Description
Apixaban, 2.5 or 5 mg Twice Daily Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
Acetylsalicylic Acid, 81-324 mg Once Daily Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion

Serious Adverse Events
    Apixaban, 2.5 or 5 mg Twice Daily   Acetylsalicylic Acid, 81-324 mg Once Daily
Total, serious adverse events     
# participants affected / at risk   657/2798 (23.48%)   804/2780 (28.92%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   12/2798 (0.43%)   11/2780 (0.40%) 
Lymphadenopathy † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Thrombocytopenia † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Aplastic anaemia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Coagulopathy † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Haemorrhagic diathesis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Iron deficiency anaemia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Leukocytosis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cardiac disorders     
Acute myocardial infarction † 1     
# participants affected / at risk   11/2798 (0.39%)   19/2780 (0.68%) 
Atrial flutter † 1     
# participants affected / at risk   7/2798 (0.25%)   6/2780 (0.22%) 
Cardiac failure † 1     
# participants affected / at risk   60/2798 (2.14%)   76/2780 (2.73%) 
Cardiogenic shock † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Palpitations † 1     
# participants affected / at risk   4/2798 (0.14%)   2/2780 (0.07%) 
Pericardial effusion † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Atrioventricular block † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Bradycardia † 1     
# participants affected / at risk   5/2798 (0.18%)   4/2780 (0.14%) 
Conduction disorder † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Left ventricular dysfunction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Mitral valve prolapse † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Ventricular failure † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Atrial fibrillation † 1     
# participants affected / at risk   72/2798 (2.57%)   70/2780 (2.52%) 
Cardio-respiratory arrest † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Cardiovascular insufficiency † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Myocardial ischaemia † 1     
# participants affected / at risk   3/2798 (0.11%)   2/2780 (0.07%) 
Sinoatrial block † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Supraventricular tachycardia † 1     
# participants affected / at risk   3/2798 (0.11%)   5/2780 (0.18%) 
Tachyarrhythmia † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Acute coronary syndrome † 1     
# participants affected / at risk   3/2798 (0.11%)   6/2780 (0.22%) 
Arrhythmia supraventricular † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Atrial tachycardia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Cardiopulmonary failure † 1     
# participants affected / at risk   2/2798 (0.07%)   3/2780 (0.11%) 
Carditis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Coronary artery disease † 1     
# participants affected / at risk   4/2798 (0.14%)   6/2780 (0.22%) 
Coronary artery insufficiency † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Intracardiac thrombus † 1     
# participants affected / at risk   3/2798 (0.11%)   3/2780 (0.11%) 
Sick sinus syndrome † 1     
# participants affected / at risk   8/2798 (0.29%)   11/2780 (0.40%) 
Ventricular tachycardia † 1     
# participants affected / at risk   3/2798 (0.11%)   3/2780 (0.11%) 
Angina unstable † 1     
# participants affected / at risk   20/2798 (0.71%)   12/2780 (0.43%) 
Atrioventricular block complete † 1     
# participants affected / at risk   3/2798 (0.11%)   2/2780 (0.07%) 
Cardiac failure congestive † 1     
# participants affected / at risk   39/2798 (1.39%)   28/2780 (1.01%) 
Cardiomyopathy † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Ischaemic cardiomyopathy † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Tachycardia † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Tricuspid valve incompetence † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Ventricular arrhythmia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Ventricular fibrillation † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Arrhythmia † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Nodal arrhythmia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Sinus arrhythmia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Sinus bradycardia † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Angina pectoris † 1     
# participants affected / at risk   4/2798 (0.14%)   9/2780 (0.32%) 
Bradyarrhythmia † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Cardiac arrest † 1     
# participants affected / at risk   3/2798 (0.11%)   7/2780 (0.25%) 
Cardiac failure chronic † 1     
# participants affected / at risk   0/2798 (0.00%)   3/2780 (0.11%) 
Cor pulmonale † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Mitral valve incompetence † 1     
# participants affected / at risk   1/2798 (0.04%)   3/2780 (0.11%) 
Myocardial infarction † 1     
# participants affected / at risk   11/2798 (0.39%)   12/2780 (0.43%) 
Aortic valve incompetence † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Cardiac failure acute † 1     
# participants affected / at risk   3/2798 (0.11%)   7/2780 (0.25%) 
Coronary artery occlusion † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Left ventricular failure † 1     
# participants affected / at risk   0/2798 (0.00%)   3/2780 (0.11%) 
Microvascular angina † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Right ventricular failure † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Congenital, familial and genetic disorders     
Atrial septal defect † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Congenital cystic kidney disease † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Ear and labyrinth disorders     
Ear disorder † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Vertigo † 1     
# participants affected / at risk   1/2798 (0.04%)   3/2780 (0.11%) 
Vertigo positional † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Endocrine disorders     
Hyperparathyroidism † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hyperthyroidism † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Thyroid haemorrhage † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hypothyroidism † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Eye disorders     
Eye haemorrhage † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Vitreous haemorrhage † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Retinal artery occlusion † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Retinal detachment † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Amaurosis fugax † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Retinal artery embolism † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Cataract † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Diverticulum † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Gastroduodenitis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Haematochezia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Intestinal ischaemia † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Pancreatitis chronic † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Abdominal hernia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Colitis † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Duodenal ulcer † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Gastric disorder † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Gastritis † 1     
# participants affected / at risk   5/2798 (0.18%)   6/2780 (0.22%) 
Gastritis erosive † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Haematemesis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Intestinal obstruction † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Lumbar hernia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Mouth haemorrhage † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Peptic ulcer † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Retroperitoneal haematoma † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Colonic polyp † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Dyspepsia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Dysphagia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Gastrooesophageal reflux disease † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Gingival bleeding † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Mesenteric artery embolism † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Oesophageal achalasia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Rectal haemorrhage † 1     
# participants affected / at risk   7/2798 (0.25%)   1/2780 (0.04%) 
Reflux oesophagitis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Subileus † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Gastric ulcer haemorrhage † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Gastrointestinal haemorrhage † 1     
# participants affected / at risk   2/2798 (0.07%)   9/2780 (0.32%) 
Gastrointestinal hypomotility † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Ileus † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Oesophagitis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pancreatitis acute † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Proctitis ulcerative † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Duodenal ulcer haemorrhage † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Duodenitis † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Gastric haemorrhage † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Gastrointestinal disorder † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Intestinal haemorrhage † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Large intestinal obstruction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Melaena † 1     
# participants affected / at risk   5/2798 (0.18%)   1/2780 (0.04%) 
Oesophageal varices haemorrhage † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Spigelian hernia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Abdominal adhesions † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Constipation † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Food poisoning † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Gastric ulcer † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Gastrointestinal perforation † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Mesenteric artery thrombosis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Nausea † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Abdominal pain † 1     
# participants affected / at risk   4/2798 (0.14%)   3/2780 (0.11%) 
Diarrhoea † 1     
# participants affected / at risk   0/2798 (0.00%)   5/2780 (0.18%) 
Faecaloma † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Inguinal hernia † 1     
# participants affected / at risk   3/2798 (0.11%)   6/2780 (0.22%) 
Oesophageal stenosis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pancreatitis † 1     
# participants affected / at risk   2/2798 (0.07%)   3/2780 (0.11%) 
Small intestinal obstruction † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Abdominal strangulated hernia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Acute abdomen † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Duodenal ulcer perforation † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Gastritis haemorrhagic † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Hiatus hernia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Splenic artery aneurysm † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Tooth loss † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Vomiting † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
General disorders     
Chest pain † 1     
# participants affected / at risk   16/2798 (0.57%)   24/2780 (0.86%) 
Gait disturbance † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Malaise † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pain † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Device pacing issue † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Implant site effusion † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Device lead damage † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Generalised oedema † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Hernia pain † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Sudden cardiac death † 1     
# participants affected / at risk   3/2798 (0.11%)   1/2780 (0.04%) 
Asthenia † 1     
# participants affected / at risk   4/2798 (0.14%)   1/2780 (0.04%) 
Cardiac death † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
General physical health deterioration † 1     
# participants affected / at risk   3/2798 (0.11%)   1/2780 (0.04%) 
Medical device complication † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Oedema peripheral † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Systemic inflammatory response syndrome † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Adverse drug reaction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Chest discomfort † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Device malfunction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Pelvic mass † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Fatigue † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hernia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Multi-organ failure † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Oedema † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pyrexia † 1     
# participants affected / at risk   3/2798 (0.11%)   3/2780 (0.11%) 
Death † 1     
# participants affected / at risk   14/2798 (0.50%)   9/2780 (0.32%) 
Non-cardiac chest pain † 1     
# participants affected / at risk   3/2798 (0.11%)   5/2780 (0.18%) 
Sudden death † 1     
# participants affected / at risk   9/2798 (0.32%)   12/2780 (0.43%) 
Swelling † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Unassigned † 1     
# participants affected / at risk   4/2798 (0.14%)   6/2780 (0.22%) 
Hepatobiliary disorders     
Cholecystitis † 1     
# participants affected / at risk   5/2798 (0.18%)   6/2780 (0.22%) 
Bile duct stone † 1     
# participants affected / at risk   1/2798 (0.04%)   3/2780 (0.11%) 
Cholestasis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Hepatitis † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Cholecystitis chronic † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Hepatic failure † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Jaundice cholestatic † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cholelithiasis † 1     
# participants affected / at risk   3/2798 (0.11%)   2/2780 (0.07%) 
Bile duct stenosis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cholangitis † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Cholecystitis acute † 1     
# participants affected / at risk   5/2798 (0.18%)   2/2780 (0.07%) 
Hyperbilirubinaemia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Liver disorder † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Infections and infestations     
Abdominal wall abscess † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Bronchitis † 1     
# participants affected / at risk   7/2798 (0.25%)   7/2780 (0.25%) 
Chronic sinusitis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Dengue fever † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hepatitis C † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Infection † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Infective exacerbation of chronic obstructive airways disease † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Lobar pneumonia † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Postoperative wound infection † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Septic shock † 1     
# participants affected / at risk   4/2798 (0.14%)   2/2780 (0.07%) 
Wound infection † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Bronchopneumonia † 1     
# participants affected / at risk   2/2798 (0.07%)   5/2780 (0.18%) 
Helicobacter gastritis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hepatic amoebiasis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Influenza † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Meningitis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Skin infection † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Tracheitis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Vestibular neuronitis † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Abscess † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Abscess limb † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Amoebic dysentery † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Lung infection † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Psoas abscess † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Staphylococcal sepsis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Viral infection † 1     
# participants affected / at risk   1/2798 (0.04%)   3/2780 (0.11%) 
Arthritis bacterial † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Endocarditis † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Escherichia bacteraemia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Gastroenteritis † 1     
# participants affected / at risk   8/2798 (0.29%)   5/2780 (0.18%) 
Klebsiella bacteraemia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Lower respiratory tract infection † 1     
# participants affected / at risk   2/2798 (0.07%)   2/2780 (0.07%) 
Osteomyelitis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Pneumonia † 1     
# participants affected / at risk   37/2798 (1.32%)   55/2780 (1.98%) 
Pneumonia klebsiella † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pneumonia pneumococcal † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pyelonephritis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pyometra † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cellulitis † 1     
# participants affected / at risk   6/2798 (0.21%)   5/2780 (0.18%) 
Clostridium colitis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Diverticulitis † 1     
# participants affected / at risk   0/2798 (0.00%)   3/2780 (0.11%) 
Gangrene † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Localised infection † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Pneumonia viral † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Respiratory tract infection † 1     
# participants affected / at risk   3/2798 (0.11%)   5/2780 (0.18%) 
Sepsis † 1     
# participants affected / at risk   4/2798 (0.14%)   4/2780 (0.14%) 
Sinusitis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Urinary tract infection † 1     
# participants affected / at risk   11/2798 (0.39%)   15/2780 (0.54%) 
Bronchiectasis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Clostridium difficile colitis † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Gastroenteritis salmonella † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Herpes zoster † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Pyelonephritis acute † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   3/2798 (0.11%)   1/2780 (0.04%) 
Urosepsis † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Appendicitis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Helicobacter infection † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Oral candidiasis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Urinary tract infection bacterial † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Injury, poisoning and procedural complications     
Concussion † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Hand fracture † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Multiple fractures † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Skull fracture † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Traumatic brain injury † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Upper limb fracture † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cerebral haemorrhage traumatic † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Drug toxicity † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Foot fracture † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Joint dislocation † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Limb traumatic amputation † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Lumbar vertebral fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Muscle strain † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Ulna fracture † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Fall † 1     
# participants affected / at risk   4/2798 (0.14%)   6/2780 (0.22%) 
Jaw fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Muscle rupture † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Post procedural diarrhoea † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Procedural pain † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Road traffic accident † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Head injury † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Lower limb fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Meniscus lesion † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Pubis fracture † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Spinal column injury † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Therapeutic agent toxicity † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Femur fracture † 1     
# participants affected / at risk   5/2798 (0.18%)   6/2780 (0.22%) 
Patella fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Post procedural fistula † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Rib fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Incisional hernia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Traumatic haematoma † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Wound secretion † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Animal bite † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Ankle fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Cervical vertebral fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Femoral neck fracture † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Humerus fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
In-stent arterial restenosis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
In-stent coronary artery restenosis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Radius fracture † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Spinal compression fracture † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Contusion † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Facial bones fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Hip fracture † 1     
# participants affected / at risk   5/2798 (0.18%)   4/2780 (0.14%) 
Injury † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Multiple injuries † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Overdose † 1     
# participants affected / at risk   3/2798 (0.11%)   5/2780 (0.18%) 
Subdural haematoma † 1     
# participants affected / at risk   4/2798 (0.14%)   2/2780 (0.07%) 
Thoracic vertebral fracture † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Investigations     
Blood magnesium decreased † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cystoscopy † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Ejection fraction decreased † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Hepatic enzyme increased † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Angiogram † 1     
# participants affected / at risk   1/2798 (0.04%)   3/2780 (0.11%) 
Arteriogram coronary † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Heart rate irregular † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Red blood cell sedimentation rate increased † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Liver function test abnormal † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Prostatic specific antigen increased † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Weight decreased † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Metabolism and nutrition disorders     
Hypoglycaemia † 1     
# participants affected / at risk   8/2798 (0.29%)   3/2780 (0.11%) 
Diabetes mellitus inadequate control † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Gout † 1     
# participants affected / at risk   2/2798 (0.07%)   2/2780 (0.07%) 
Hyperkalaemia † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Malnutrition † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Decreased appetite † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Starvation † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Type 2 diabetes mellitus † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Cachexia † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Dehydration † 1     
# participants affected / at risk   7/2798 (0.25%)   5/2780 (0.18%) 
Hypokalaemia † 1     
# participants affected / at risk   0/2798 (0.00%)   3/2780 (0.11%) 
Hyponatraemia † 1     
# participants affected / at risk   4/2798 (0.14%)   3/2780 (0.11%) 
Obesity † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Electrolyte imbalance † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Hyperglycaemia † 1     
# participants affected / at risk   3/2798 (0.11%)   1/2780 (0.04%) 
Hypovolaemia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Diabetes mellitus † 1     
# participants affected / at risk   5/2798 (0.18%)   4/2780 (0.14%) 
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Musculoskeletal stiffness † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Osteochondrosis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Spinal column stenosis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Myopathy † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Rotator cuff syndrome † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Spinal osteoarthritis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Joint swelling † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Musculoskeletal chest pain † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Osteoarthritis † 1     
# participants affected / at risk   11/2798 (0.39%)   3/2780 (0.11%) 
Polyarthritis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Intervertebral disc protrusion † 1     
# participants affected / at risk   0/2798 (0.00%)   4/2780 (0.14%) 
Muscle spasms † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pain in extremity † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Systemic lupus erythematosus † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Back pain † 1     
# participants affected / at risk   5/2798 (0.18%)   3/2780 (0.11%) 
Gouty arthritis † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Haemarthrosis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Muscle haemorrhage † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Osteopenia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Arthralgia † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Musculoskeletal pain † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer † 1     
# participants affected / at risk   9/2798 (0.32%)   1/2780 (0.04%) 
Cholesteatoma † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Colon cancer metastatic † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Gastric cancer † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Laryngeal cancer † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Lip and/or oral cavity cancer † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Lung neoplasm malignant † 1     
# participants affected / at risk   3/2798 (0.11%)   5/2780 (0.18%) 
Neoplasm prostate † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Non-Hodgkin's lymphoma stage III † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pancreatic carcinoma † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Prostatic adenoma † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Uterine leiomyoma † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Bladder cancer † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Brain neoplasm benign † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Omentum neoplasm † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Renal cell carcinoma † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Breast cancer metastatic † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Bronchial carcinoma † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Leukaemia † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Metastases to abdominal cavity † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Biliary neoplasm † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hepatic neoplasm malignant † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Malignant melanoma † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Non-Hodgkin's lymphoma † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Lipoma † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Lung adenocarcinoma metastatic † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Lung cancer metastatic † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Lymph node cancer metastatic † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Metastases to central nervous system † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Neoplasm malignant † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Rectal cancer metastatic † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Sebaceous carcinoma † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Squamous cell carcinoma † 1     
# participants affected / at risk   2/2798 (0.07%)   4/2780 (0.14%) 
Cervix carcinoma stage 0 † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Gastrointestinal carcinoma † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Leiomyoma † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Malignant melanoma stage I † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Pelvic neoplasm † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Renal cancer stage III † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Squamous cell carcinoma of skin † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Basal cell carcinoma † 1     
# participants affected / at risk   5/2798 (0.18%)   5/2780 (0.18%) 
Basosquamous carcinoma † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Colon cancer † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Liposarcoma † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Prostate cancer recurrent † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Renal neoplasm † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Colon neoplasm † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Endometrial cancer † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Gallbladder cancer † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Lymphoma † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Metastases to liver † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Prostate cancer † 1     
# participants affected / at risk   7/2798 (0.25%)   10/2780 (0.36%) 
Rectal cancer † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Renal cancer † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Nervous system disorders     
Cerebral infarction † 1     
# participants affected / at risk   1/2798 (0.04%)   6/2780 (0.22%) 
Dementia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Dizziness † 1     
# participants affected / at risk   1/2798 (0.04%)   10/2780 (0.36%) 
Haemorrhagic cerebral infarction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Lethargy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Loss of consciousness † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Metabolic encephalopathy † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Peripheral nerve palsy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Tremor † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Vertebrobasilar insufficiency † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Migraine † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Parkinson's disease † 1     
# participants affected / at risk   0/2798 (0.00%)   4/2780 (0.14%) 
Subarachnoid haemorrhage † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Cerebral haemorrhage † 1     
# participants affected / at risk   3/2798 (0.11%)   1/2780 (0.04%) 
Cubital tunnel syndrome † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Depressed level of consciousness † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Embolic stroke † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Hemiparesis † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Partial seizures † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Presyncope † 1     
# participants affected / at risk   5/2798 (0.18%)   2/2780 (0.07%) 
Sciatica † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
VIIth nerve paralysis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Cerebral microhaemorrhage † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Cerebral thrombosis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Cervical root pain † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Encephalopathy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Epilepsy † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Lumbar radiculopathy † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Neuropathy peripheral † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Paraesthesia † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Cerebral haematoma † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Convulsion † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Headache † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Ischaemic stroke † 1     
# participants affected / at risk   19/2798 (0.68%)   46/2780 (1.65%) 
Lacunar infarction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Transient ischaemic attack † 1     
# participants affected / at risk   10/2798 (0.36%)   29/2780 (1.04%) 
Vascular encephalopathy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Diabetic hyperglycaemic coma † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Haemorrhagic stroke † 1     
# participants affected / at risk   5/2798 (0.18%)   6/2780 (0.22%) 
Aphasia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Brain stem infarction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Carotid arterial embolus † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Cerebral cyst † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cerebrovascular disorder † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Ischaemic cerebral infarction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Syncope † 1     
# participants affected / at risk   8/2798 (0.29%)   18/2780 (0.65%) 
Altered state of consciousness † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Brain stem haemorrhage † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cerebellar ataxia † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cerebrovascular accident † 1     
# participants affected / at risk   16/2798 (0.57%)   40/2780 (1.44%) 
Psychiatric disorders     
Alcohol abuse † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Anxiety † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Panic attack † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Confusional state † 1     
# participants affected / at risk   3/2798 (0.11%)   0/2780 (0.00%) 
Bipolar disorder † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Delirium † 1     
# participants affected / at risk   0/2798 (0.00%)   3/2780 (0.11%) 
Psychotic disorder † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Alcohol withdrawal syndrome † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Depression † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Renal and urinary disorders     
Calculus ureteric † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hypertensive nephropathy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Renal failure acute † 1     
# participants affected / at risk   8/2798 (0.29%)   9/2780 (0.32%) 
Urinary incontinence † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Dysuria † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Renal failure † 1     
# participants affected / at risk   1/2798 (0.04%)   6/2780 (0.22%) 
Urinary retention † 1     
# participants affected / at risk   3/2798 (0.11%)   2/2780 (0.07%) 
Renal impairment † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Renal infarct † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Bladder mass † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Haematuria † 1     
# participants affected / at risk   5/2798 (0.18%)   4/2780 (0.14%) 
Renal failure chronic † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Urethral disorder † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Renal colic † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Calculus urinary † 1     
# participants affected / at risk   3/2798 (0.11%)   0/2780 (0.00%) 
Reproductive system and breast disorders     
Prostatic obstruction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Menometrorrhagia † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Benign prostatic hyperplasia † 1     
# participants affected / at risk   2/2798 (0.07%)   3/2780 (0.11%) 
Vaginal haemorrhage † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Emphysema † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Epistaxis † 1     
# participants affected / at risk   5/2798 (0.18%)   6/2780 (0.22%) 
Lung infiltration † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Mediastinal mass † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Haemothorax † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Pulmonary fibrosis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Respiratory arrest † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Sleep apnoea syndrome † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Allergic bronchitis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   12/2798 (0.43%)   9/2780 (0.32%) 
Dyspnoea † 1     
# participants affected / at risk   13/2798 (0.46%)   11/2780 (0.40%) 
Haemoptysis † 1     
# participants affected / at risk   3/2798 (0.11%)   2/2780 (0.07%) 
Pulmonary artery thrombosis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Respiratory failure † 1     
# participants affected / at risk   4/2798 (0.14%)   9/2780 (0.32%) 
Dyspnoea exertional † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hiccups † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Lung disorder † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Orthopnoea † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pulmonary embolism † 1     
# participants affected / at risk   2/2798 (0.07%)   11/2780 (0.40%) 
Pulmonary oedema † 1     
# participants affected / at risk   2/2798 (0.07%)   2/2780 (0.07%) 
Sinus polyp † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Acute pulmonary oedema † 1     
# participants affected / at risk   4/2798 (0.14%)   2/2780 (0.07%) 
Acute respiratory distress syndrome † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cough † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pleural effusion † 1     
# participants affected / at risk   1/2798 (0.04%)   4/2780 (0.14%) 
Acute respiratory failure † 1     
# participants affected / at risk   4/2798 (0.14%)   0/2780 (0.00%) 
Asthma † 1     
# participants affected / at risk   6/2798 (0.21%)   3/2780 (0.11%) 
Bronchitis chronic † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Bronchospasm † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Pneumonia aspiration † 1     
# participants affected / at risk   3/2798 (0.11%)   2/2780 (0.07%) 
Pneumothorax † 1     
# participants affected / at risk   2/2798 (0.07%)   2/2780 (0.07%) 
Pulmonary hypertension † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Respiratory distress † 1     
# participants affected / at risk   0/2798 (0.00%)   3/2780 (0.11%) 
Skin and subcutaneous tissue disorders     
Blood blister † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Skin lesion † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Decubitus ulcer † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Dermatitis herpetiformis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Purpura † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Rash erythematous † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Angioedema † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Social circumstances     
Activities of daily living impaired † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Physical assault † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Surgical and medical procedures     
Cataract operation † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Fasciotomy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Gallbladder operation † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Genitourinary operation † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Haemorrhoid operation † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Knee arthroplasty † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Papilloma excision † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Skin graft † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Abdominoplasty † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cardiac pacemaker removal † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Cardiac pacemaker replacement † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Cholecystectomy † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Implantable defibrillator insertion † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Prostatic operation † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Tarsal tunnel decompression † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Coronary artery bypass † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hysterectomy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Implantable defibrillator replacement † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Inguinal hernia repair † 1     
# participants affected / at risk   4/2798 (0.14%)   0/2780 (0.00%) 
Peripheral artery angioplasty † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Therapeutic embolisation † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Transfusion † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Vertebroplasty † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cardiac ablation † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Cardiac pacemaker insertion † 1     
# participants affected / at risk   4/2798 (0.14%)   2/2780 (0.07%) 
Orchidectomy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Percutaneous coronary intervention † 1     
# participants affected / at risk   2/2798 (0.07%)   2/2780 (0.07%) 
Skin neoplasm excision † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Spinal fusion surgery † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Toe amputation † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Tooth extraction † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Transurethral prostatectomy † 1     
# participants affected / at risk   1/2798 (0.04%)   4/2780 (0.14%) 
Cardiac pacemaker battery replacement † 1     
# participants affected / at risk   3/2798 (0.11%)   0/2780 (0.00%) 
Coronary angioplasty † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hip arthroplasty † 1     
# participants affected / at risk   2/2798 (0.07%)   1/2780 (0.04%) 
Hip surgery † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Uterine dilation and curettage † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Angioplasty † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Eye operation † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Heart valve operation † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Hospitalisation † 1     
# participants affected / at risk   3/2798 (0.11%)   2/2780 (0.07%) 
Mastectomy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Salivary gland operation † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Mitral valve repair † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Renal stone removal † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Thromboembolectomy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Appendicectomy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Bursal operation † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Cardioversion † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Hernia repair † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Incisional hernia repair † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Rectal polypectomy † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Vascular disorders     
Hypertensive crisis † 1     
# participants affected / at risk   6/2798 (0.21%)   3/2780 (0.11%) 
Intermittent claudication † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Arteriosclerosis obliterans † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Deep vein thrombosis † 1     
# participants affected / at risk   2/2798 (0.07%)   6/2780 (0.22%) 
Thrombophlebitis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Femoral artery embolism † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Haemorrhage † 1     
# participants affected / at risk   1/2798 (0.04%)   3/2780 (0.11%) 
Lymphocele † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Peripheral embolism † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Venous insufficiency † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Aortic rupture † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Arterial thrombosis limb † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Femoral artery occlusion † 1     
# participants affected / at risk   0/2798 (0.00%)   3/2780 (0.11%) 
Hypertension † 1     
# participants affected / at risk   4/2798 (0.14%)   9/2780 (0.32%) 
Orthostatic hypotension † 1     
# participants affected / at risk   1/2798 (0.04%)   6/2780 (0.22%) 
Thrombosis † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Venous thrombosis † 1     
# participants affected / at risk   0/2798 (0.00%)   2/2780 (0.07%) 
Aortic dissection † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Arterial stenosis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Shock † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Thrombophlebitis superficial † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Aortic aneurysm † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Aortic stenosis † 1     
# participants affected / at risk   2/2798 (0.07%)   0/2780 (0.00%) 
Arteriosclerosis † 1     
# participants affected / at risk   1/2798 (0.04%)   0/2780 (0.00%) 
Haematoma † 1     
# participants affected / at risk   1/2798 (0.04%)   2/2780 (0.07%) 
Pallor † 1     
# participants affected / at risk   1/2798 (0.04%)   1/2780 (0.04%) 
Peripheral arterial occlusive disease † 1     
# participants affected / at risk   0/2798 (0.00%)   4/2780 (0.14%) 
Varicose vein † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Hypotension † 1     
# participants affected / at risk   3/2798 (0.11%)   4/2780 (0.14%) 
Peripheral ischaemia † 1     
# participants affected / at risk   0/2798 (0.00%)   5/2780 (0.18%) 
Phlebitis † 1     
# participants affected / at risk   0/2798 (0.00%)   1/2780 (0.04%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.1




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
On May 28, 2010, after a planned interim analysis for efficacy, the Data Monitoring Committee recommended early termination due to apixaban's superior efficacy over ASA, with an acceptable safety profile. The open-label phase is ongoing.


  More Information
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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: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


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


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00496769     History of Changes
Other Study ID Numbers: CV185-048
Study First Received: July 2, 2007
Results First Received: August 1, 2013
Last Updated: March 1, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Mexico: Federal Commission for Sanitary Risks Protection
Austria: Agency for Health and Food Safety
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Ministry of Health
Germany: Ministry of Health
Greece: National Organization of Medicines
Israel: Ministry of Health
Italy: Ministry of Health
Norway: Ministry of Health and Social Affairs
Spain: Spanish Agency of Medicines
South Africa: Department of Health
Sweden: The National Board of Health and Welfare
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: Ministry of Health
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
China: National Institute for the Control of Pharmaceutical and Biological Products
Hong Kong: Department of Health
India: Central Drugs Standard Control Organization
Indonesia: Ministry of Health
Korea: Food and Drug Administration
Malaysia: National Pharmaceutical Control Bureau
Philippines: Department of Health
Singapore: Ministry of Health
Taiwan: Department of Health