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Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane (TEAM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00036270
First received: May 8, 2002
Last updated: October 6, 2015
Last verified: October 2015
Results First Received: October 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: exemestane (Aromasin)
Drug: tamoxifen + exemestane

  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
Exemestane Exemestane (Aromasin®) 25 milligram (mg) once daily (QD) for 5 years.
Tamoxifen Followed by Exemestane Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.

Participant Flow for 2 periods

Period 1:   Randomized to Study Treatment
    Exemestane   Tamoxifen Followed by Exemestane
STARTED   4904   4875 
COMPLETED   4898   4868 
NOT COMPLETED   6   7 
Withdrawal by Subject                6                7 

Period 2:   Study Treatment to 5 Year Report
    Exemestane   Tamoxifen Followed by Exemestane
STARTED   4898   4868 
Treated   4852   4814 
COMPLETED   2333   1380 
NOT COMPLETED   2565   3488 
Ongoing                1081                736 
Disease- Free Survival (DFS) event                507                447 
Adverse Event                501                782 
Unspecified                277                288 
Treatment refusal                113                208 
Randomized but not treated                46                54 
Protocol Violation                23                91 
Intercurrent illness                17                29 
Too early switch                0                103 
No/too late switch/refusal to switch                0                750 



  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
Exemestane Exemestane (Aromasin®) 25 mg QD for 5 years.
Tamoxifen Followed by Exemestane Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
Total Total of all reporting groups

Baseline Measures
   Exemestane   Tamoxifen Followed by Exemestane   Total 
Overall Participants Analyzed 
[Units: Participants]
 4898   4868   9766 
Age 
[Units: Years]
Mean (Standard Deviation)
 65  (9)   64  (9)   64  (9) 
Age, Customized 
[Units: Participants]
     
Less than 50 years   171   160   331 
50 to 59 years   1510   1507   3017 
60 to 69 years   1835   1896   3731 
Greater than and equal to 70 years   1382   1305   2687 
Gender 
[Units: Participants]
     
Female   4898   4868   9766 
Male   0   0   0 


  Outcome Measures
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1.  Primary:   Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years   [ Time Frame: Baseline (Month 0) up to 2.75 years ]

2.  Primary:   Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years   [ Time Frame: Baseline (Month 0) up to 5 years ]

3.  Secondary:   Number of Events for Overall Survival (OS)   [ Time Frame: Baseline (Month 0) up to 5 years ]

4.  Secondary:   Time to New Primary Breast Cancers   [ Time Frame: Baseline (Month 0) up to 5 years ]

5.  Secondary:   Number of Events for Time to Relapse   [ Time Frame: Baseline (Month 0) up to 5 years ]

6.  Secondary:   Number of Participants With New Primary Non-breast Cancers   [ Time Frame: Baseline (Month 0) up to 5 years ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Reporting Groups
  Description
Tamoxifen Followed by Exemestane Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
Exemestane Exemestane (Aromasin®) 25 mg QD for 5 years

Serious Adverse Events
    Tamoxifen Followed by Exemestane   Exemestane
Total, serious adverse events     
# participants affected / at risk   784/4814 (16.29%)   831/4852 (17.13%) 
Blood and lymphatic system disorders     
Anaemia * 1     
# participants affected / at risk   5/4814 (0.10%)   12/4852 (0.25%) 
Anaemia vitamin B12 deficiency * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Coagulopathy * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Febrile neutropenia * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Haemorrhagic anaemia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Iron deficiency anaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Leukocytosis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Leukopenia * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Lymphadenopathy * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Neutropenia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Pancytopenia * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Thrombocytopenia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cardiac disorders     
Acute coronary syndrome * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Acute myocardial infarction * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Angina pectoris * 1     
# participants affected / at risk   7/4814 (0.15%)   8/4852 (0.16%) 
Angina unstable * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Aortic valve incompetence * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Aortic valve stenosis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Arrhythmia * 1     
# participants affected / at risk   0/4814 (0.00%)   4/4852 (0.08%) 
Arrhythmia supraventricular * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Atrial fibrillation * 1     
# participants affected / at risk   15/4814 (0.31%)   18/4852 (0.37%) 
Atrial flutter * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Atrial tachycardia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Atrioventricular block * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Atrioventricular block complete * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Bradycardia * 1     
# participants affected / at risk   1/4814 (0.02%)   4/4852 (0.08%) 
Cardiac arrest * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cardiac asthma * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cardiac disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Cardiac failure * 1     
# participants affected / at risk   7/4814 (0.15%)   9/4852 (0.19%) 
Cardiac failure congestive * 1     
# participants affected / at risk   6/4814 (0.12%)   12/4852 (0.25%) 
Cardiac valve disease * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cardiomyopathy * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Cardiopulmonary failure * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cardiovascular disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Congestive cardiomyopathy * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Cor pulmonale * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Coronary artery disease * 1     
# participants affected / at risk   7/4814 (0.15%)   8/4852 (0.16%) 
Coronary artery insufficiency * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Coronary artery occlusion * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Coronary artery stenosis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Cytotoxic cardiomyopathy * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Intracardiac thrombus * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Left ventricular failure * 1     
# participants affected / at risk   0/4814 (0.00%)   4/4852 (0.08%) 
Mitral valve incompetence * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Myocardial infarction * 1     
# participants affected / at risk   18/4814 (0.37%)   18/4852 (0.37%) 
Myocardial ischaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   4/4852 (0.08%) 
Palpitations * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Pericardial effusion * 1     
# participants affected / at risk   0/4814 (0.00%)   5/4852 (0.10%) 
Pleuropericarditis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Prinzmetal angina * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Right ventricular failure * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Sick sinus syndrome * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Sinus bradycardia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Sinus tachycardia * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Supraventricular tachycardia * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Tachyarrhythmia * 1     
# participants affected / at risk   0/4814 (0.00%)   3/4852 (0.06%) 
Tachycardia * 1     
# participants affected / at risk   4/4814 (0.08%)   1/4852 (0.02%) 
Ventricular fibrillation * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Ventricular tachycardia * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Congenital, familial and genetic disorders     
Adenomatous polyposis coli * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Congenital musculoskeletal anomaly * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Dermoid cyst * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Skull malformation * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Spine malformation * 1     
# participants affected / at risk   3/4814 (0.06%)   0/4852 (0.00%) 
Ear and labyrinth disorders     
Deafness unilateral * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Otosclerosis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Tinnitus * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Tympanic membrane disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Vertigo * 1     
# participants affected / at risk   7/4814 (0.15%)   1/4852 (0.02%) 
Endocrine disorders     
Goitre * 1     
# participants affected / at risk   3/4814 (0.06%)   6/4852 (0.12%) 
Hyperparathyroidism * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Hyperthyroidism * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Hypothyroidism * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Thyroid disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Thyroiditis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Toxic nodular goitre * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Eye disorders     
Cataract * 1     
# participants affected / at risk   2/4814 (0.04%)   3/4852 (0.06%) 
Eye disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Eye pain * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Glaucoma * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Retinal detachment * 1     
# participants affected / at risk   0/4814 (0.00%)   3/4852 (0.06%) 
Retinal disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Retinal haemorrhage * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Retinal ischaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Retinal vein occlusion * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Visual acuity reduced * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Visual impairment * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Vitreous detachment * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Gastrointestinal disorders     
Abdominal distension * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Abdominal hernia * 1     
# participants affected / at risk   0/4814 (0.00%)   3/4852 (0.06%) 
Abdominal pain * 1     
# participants affected / at risk   11/4814 (0.23%)   14/4852 (0.29%) 
Abdominal pain lower * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Abdominal pain upper * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Acute abdomen * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Anal fissure * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Anal prolapse * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Ascites * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Colitis * 1     
# participants affected / at risk   0/4814 (0.00%)   3/4852 (0.06%) 
Colonic polyp * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Constipation * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Crohn’s disease * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Diarrhoea * 1     
# participants affected / at risk   7/4814 (0.15%)   10/4852 (0.21%) 
Diarrhoea haemorrhagic * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Diverticulum * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Diverticulum intestinal * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Duodenal ulcer haemorrhage * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Enteritis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Enterocolitis haemorrhagic * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Epigastric discomfort * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Femoral hernia, obstructive * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Gastric haemorrhage * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Gastric ulcer * 1     
# participants affected / at risk   2/4814 (0.04%)   4/4852 (0.08%) 
Gastric ulcer haemorrhage * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Gastric ulcer perforation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Gastritis * 1     
# participants affected / at risk   2/4814 (0.04%)   6/4852 (0.12%) 
Gastritis erosive * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Gastrointestinal disorder * 1     
# participants affected / at risk   4/4814 (0.08%)   1/4852 (0.02%) 
Gastrointestinal haemorrhage * 1     
# participants affected / at risk   4/4814 (0.08%)   6/4852 (0.12%) 
Gastrointestinal pain * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Gastrointestinal tract irritation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Gastrooesophageal reflux disease * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Haematemesis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Haematochezia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Haemorrhoids * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Hiatus hernia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Ileus * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Inguinal hernia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Intestinal ischaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Intestinal obstruction * 1     
# participants affected / at risk   5/4814 (0.10%)   4/4852 (0.08%) 
Intestinal perforation * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Intestinal polyp * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Large intestine perforation * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Melaena * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Mesenteric occlusion * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Nausea * 1     
# participants affected / at risk   3/4814 (0.06%)   5/4852 (0.10%) 
Obstruction gastric * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Oesophageal disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Oesophageal haemorrhage * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Oesophageal stenosis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Oesophagitis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Pancreatitis * 1     
# participants affected / at risk   7/4814 (0.15%)   5/4852 (0.10%) 
Pancreatitis acute * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Peptic ulcer * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Peritonitis * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Proctalgia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Rectal haemorrhage * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Reflux oesophagitis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Small intestinal obstruction * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Splenic artery aneurysm * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Stomatitis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Tongue oedema * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Tongue ulceration * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Vomiting * 1     
# participants affected / at risk   9/4814 (0.19%)   6/4852 (0.12%) 
General disorders     
Adverse drug reaction * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Asthenia * 1     
# participants affected / at risk   3/4814 (0.06%)   6/4852 (0.12%) 
Calcinosis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Cardiac death * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Chest discomfort * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Chest pain * 1     
# participants affected / at risk   15/4814 (0.31%)   16/4852 (0.33%) 
Condition aggravated * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Cyst * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Death * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Device breakage * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Device occlusion * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Disease progression * 1     
# participants affected / at risk   0/4814 (0.00%)   4/4852 (0.08%) 
Dysplasia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Fat necrosis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Fat tissue increased * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Fatigue * 1     
# participants affected / at risk   4/4814 (0.08%)   4/4852 (0.08%) 
Gait disturbance * 1     
# participants affected / at risk   4/4814 (0.08%)   1/4852 (0.02%) 
General physical health deterioration * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Hernia * 1     
# participants affected / at risk   3/4814 (0.06%)   5/4852 (0.10%) 
Hyperplasia * 1     
# participants affected / at risk   3/4814 (0.06%)   1/4852 (0.02%) 
Ill-defined disorder * 1     
# participants affected / at risk   4/4814 (0.08%)   8/4852 (0.16%) 
Impaired healing * 1     
# participants affected / at risk   3/4814 (0.06%)   0/4852 (0.00%) 
Implant site fibrosis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Local swelling * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Malaise * 1     
# participants affected / at risk   3/4814 (0.06%)   1/4852 (0.02%) 
Medical device complication * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Multi-organ failure * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Necrosis * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Nodule * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Oedema * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Oedema due to cardiac disease * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Oedema peripheral * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Pain * 1     
# participants affected / at risk   13/4814 (0.27%)   3/4852 (0.06%) 
Polyp * 1     
# participants affected / at risk   4/4814 (0.08%)   1/4852 (0.02%) 
Pseudocyst * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Pyrexia * 1     
# participants affected / at risk   7/4814 (0.15%)   5/4852 (0.10%) 
Sense of oppression * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Sudden death * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Swelling * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Hepatobiliary disorders     
Bile duct stone * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Biliary colic * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Cholecystitis * 1     
# participants affected / at risk   13/4814 (0.27%)   11/4852 (0.23%) 
Cholecystitis acute * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Cholecystitis chronic * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Cholelithiasis * 1     
# participants affected / at risk   10/4814 (0.21%)   14/4852 (0.29%) 
Gallbladder perforation * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hepatic cirrhosis * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Hepatic cyst * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Hepatic function abnormal * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Hepatitis * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Liver disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Immune system disorders     
Anaphylactic reaction * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hypersensitivity * 1     
# participants affected / at risk   1/4814 (0.02%)   4/4852 (0.08%) 
Sarcoidosis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Infections and infestations     
Abscess * 1     
# participants affected / at risk   3/4814 (0.06%)   1/4852 (0.02%) 
Abscess limb * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Appendicitis * 1     
# participants affected / at risk   4/4814 (0.08%)   7/4852 (0.14%) 
Appendicitis perforated * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Arthritis bacterial * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Bacterial infection * 1     
# participants affected / at risk   1/4814 (0.02%)   5/4852 (0.10%) 
Breast abscess * 1     
# participants affected / at risk   4/4814 (0.08%)   2/4852 (0.04%) 
Breast cellulitis * 1     
# participants affected / at risk   3/4814 (0.06%)   2/4852 (0.04%) 
Breast infection * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Bronchitis * 1     
# participants affected / at risk   6/4814 (0.12%)   2/4852 (0.04%) 
Bronchopneumonia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cellulitis * 1     
# participants affected / at risk   11/4814 (0.23%)   7/4852 (0.14%) 
Cystitis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Device related infection * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Diverticulitis * 1     
# participants affected / at risk   7/4814 (0.15%)   10/4852 (0.21%) 
Endocarditis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Endometritis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Erysipelas * 1     
# participants affected / at risk   9/4814 (0.19%)   7/4852 (0.14%) 
Escherichia urinary tract infection * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Gangrene * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Gastroenteritis * 1     
# participants affected / at risk   6/4814 (0.12%)   4/4852 (0.08%) 
Gastroenteritis salmonella * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Groin abscess * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hepatitis C * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Herpes zoster * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Infection * 1     
# participants affected / at risk   5/4814 (0.10%)   11/4852 (0.23%) 
Lobar pneumonia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Localised infection * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Lower respiratory tract infection * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Lower respiratory tract infection bacterial * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Lung infection * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Lymphangitis * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Mastitis * 1     
# participants affected / at risk   6/4814 (0.12%)   5/4852 (0.10%) 
Meningitis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Molluscum contagiosum * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Nasopharyngitis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Osteomyelitis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Pelvic inflammatory disease * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Pneumonia * 1     
# participants affected / at risk   26/4814 (0.54%)   25/4852 (0.52%) 
Pneumonia primary atypical * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Post procedural cellulitis * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Post procedural infection * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Pseudomembranous colitis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Pyelonephritis * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Pyelonephritis acute * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Pyoderma * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Sepsis * 1     
# participants affected / at risk   10/4814 (0.21%)   4/4852 (0.08%) 
Streptococcal sepsis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Subcutaneous abscess * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Upper respiratory tract infection * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Urinary tract infection * 1     
# participants affected / at risk   6/4814 (0.12%)   7/4852 (0.14%) 
Urosepsis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Vestibular neuronitis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Viral infection * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Wound infection * 1     
# participants affected / at risk   5/4814 (0.10%)   0/4852 (0.00%) 
Injury, poisoning and procedural complications     
Acetabulum fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Animal bite * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Ankle fracture * 1     
# participants affected / at risk   6/4814 (0.12%)   8/4852 (0.16%) 
Breast injury * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cervical vertebral fracture * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Clavicle fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Compression fracture * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Concussion * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Contusion * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Deep vein thrombosis postoperative * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Delayed recovery from anaesthesia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Fall * 1     
# participants affected / at risk   7/4814 (0.15%)   9/4852 (0.19%) 
Femoral neck fracture * 1     
# participants affected / at risk   2/4814 (0.04%)   3/4852 (0.06%) 
Femur fracture * 1     
# participants affected / at risk   3/4814 (0.06%)   4/4852 (0.08%) 
Fibula fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Foot fracture * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Forearm fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Fracture * 1     
# participants affected / at risk   15/4814 (0.31%)   27/4852 (0.56%) 
Fractured sacrum * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Hand fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Head injury * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hip fracture * 1     
# participants affected / at risk   3/4814 (0.06%)   8/4852 (0.16%) 
Humerus fracture * 1     
# participants affected / at risk   2/4814 (0.04%)   10/4852 (0.21%) 
Incisional hernia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Injury * 1     
# participants affected / at risk   3/4814 (0.06%)   0/4852 (0.00%) 
Joint dislocation * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Joint injury * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Joint sprain * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Laceration * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Lower limb fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Lumbar vertebral fracture * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Meniscus lesion * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Overdose * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Patella fracture * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Pelvic fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   5/4852 (0.10%) 
Poisoning * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Postoperative thrombosis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Postoperative wound complication * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Procedural pain * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Pubis fracture * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Radiation fibrosis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Radiation pneumonitis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Radiation skin injury * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Radius fracture * 1     
# participants affected / at risk   0/4814 (0.00%)   4/4852 (0.08%) 
Rib fracture * 1     
# participants affected / at risk   2/4814 (0.04%)   3/4852 (0.06%) 
Road traffic accident * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Seroma * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Spinal column injury * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Spinal compression fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Spinal fracture * 1     
# participants affected / at risk   3/4814 (0.06%)   3/4852 (0.06%) 
Subdural haematoma * 1     
# participants affected / at risk   3/4814 (0.06%)   2/4852 (0.04%) 
Tendon rupture * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Tibia fracture * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Toxicity to various agents * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Ulna fracture * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Upper limb fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   4/4852 (0.08%) 
Vascular bypass dysfunction * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Wrist fracture * 1     
# participants affected / at risk   5/4814 (0.10%)   6/4852 (0.12%) 
Investigations     
Blood calcium increased * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Blood test abnormal * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
CSF test abnormal * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Carbohydrate antigen 15-3 increased * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Clostridium test positive * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Coagulation test * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Electrocardiogram abnormal * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Gamma-glutamyltransferase increased * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Haemoglobin * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Heart rate irregular * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Investigation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Occult blood positive * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Prothrombin level increased * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Weight decreased * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Metabolism and nutrition disorders     
Cachexia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Dehydration * 1     
# participants affected / at risk   2/4814 (0.04%)   9/4852 (0.19%) 
Diabetes mellitus * 1     
# participants affected / at risk   4/4814 (0.08%)   6/4852 (0.12%) 
Enzyme abnormality * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Hypercalcaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Hypercholesterolaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hyperglycaemia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Hypoglycaemia * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Hypokalaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Hypomagnesaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hyponatraemia * 1     
# participants affected / at risk   3/4814 (0.06%)   5/4852 (0.10%) 
Type 1 diabetes mellitus * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1     
# participants affected / at risk   5/4814 (0.10%)   8/4852 (0.16%) 
Arthritis * 1     
# participants affected / at risk   11/4814 (0.23%)   14/4852 (0.29%) 
Arthropathy * 1     
# participants affected / at risk   3/4814 (0.06%)   7/4852 (0.14%) 
Back pain * 1     
# participants affected / at risk   6/4814 (0.12%)   7/4852 (0.14%) 
Bone disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Bone pain * 1     
# participants affected / at risk   2/4814 (0.04%)   4/4852 (0.08%) 
Bursitis * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
CREST syndrome * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Chondropathy * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Flank pain * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Foot deformity * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Groin pain * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Intervertebral disc protrusion * 1     
# participants affected / at risk   3/4814 (0.06%)   7/4852 (0.14%) 
Joint stiffness * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Joint swelling * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Lumbar spinal stenosis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Monarthritis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Muscle spasms * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Muscular weakness * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Musculoskeletal chest pain * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Musculoskeletal disorder * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Musculoskeletal pain * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Myalgia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Neck pain * 1     
# participants affected / at risk   1/4814 (0.02%)   5/4852 (0.10%) 
Osteoarthritis * 1     
# participants affected / at risk   14/4814 (0.29%)   34/4852 (0.70%) 
Osteolysis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Osteonecrosis * 1     
# participants affected / at risk   2/4814 (0.04%)   3/4852 (0.06%) 
Osteonecrosis of jaw * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Osteoporosis * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Osteoporosis postmenopausal * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Osteoporotic fracture * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Pain in extremity * 1     
# participants affected / at risk   3/4814 (0.06%)   0/4852 (0.00%) 
Pathological fracture * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Polyarthritis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Rotator cuff syndrome * 1     
# participants affected / at risk   3/4814 (0.06%)   0/4852 (0.00%) 
Spinal column stenosis * 1     
# participants affected / at risk   0/4814 (0.00%)   3/4852 (0.06%) 
Spinal osteoarthritis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Synovial cyst * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Synovitis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Systemic sclerosis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Tendonitis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acoustic neuroma * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Adenocarcinoma * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Adenoma benign * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Basal cell carcinoma * 1     
# participants affected / at risk   1/4814 (0.02%)   4/4852 (0.08%) 
Benign breast neoplasm * 1     
# participants affected / at risk   4/4814 (0.08%)   2/4852 (0.04%) 
Benign lymph node neoplasm * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Benign neoplasm of skin * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Benign ovarian tumour * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Benign renal neoplasm * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Benign respiratory tract neoplasm * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Bile duct cancer * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Bladder cancer recurrent * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Bowen’s disease * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Breast cancer * 1     
# participants affected / at risk   2/4814 (0.04%)   3/4852 (0.06%) 
Breast cancer metastatic * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Breast cancer recurrent * 1     
# participants affected / at risk   0/4814 (0.00%)   4/4852 (0.08%) 
Cholesteatoma * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Colon cancer * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Colorectal cancer * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Contralateral breast cancer * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Dermatofibrosarcoma * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Endometrial cancer * 1     
# participants affected / at risk   2/4814 (0.04%)   3/4852 (0.06%) 
Fibroadenoma of breast * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Gastrointestinal neoplasm * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Haemangioma * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Hepatic neoplasm * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hepatic neoplasm malignant * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Laryngeal cancer * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Lipoma * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Lung neoplasm * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Lung neoplasm malignant * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Lymphoma * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Malignant melanoma * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Malignant peritoneal neoplasm * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Malignant pleural effusion * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Mantle cell lymphoma * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Meningioma * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Metastases to bone * 1     
# participants affected / at risk   4/4814 (0.08%)   8/4852 (0.16%) 
Metastases to central nervous system * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Metastases to liver * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Metastases to lung * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Metastases to pancreas * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Metastases to pleura * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Metastases to skin * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Metastases to spine * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Metastases to stomach * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Metastasis * 1     
# participants affected / at risk   2/4814 (0.04%)   3/4852 (0.06%) 
Mueller’s mixed tumour * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Myelodysplastic syndrome * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Neoplasm * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Neoplasm malignant * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Neoplasm recurrence * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Neuroma * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Ovarian adenoma * 1     
# participants affected / at risk   0/4814 (0.00%)   3/4852 (0.06%) 
Ovarian cancer * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Ovarian germ cell teratoma benign * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Ovarian neoplasm * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Paget’s disease of the breast * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Pancreatic carcinoma * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Pharyngeal neoplasm * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Rectal cancer * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Thyroid adenoma * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Thyroid cancer * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Thyroid neoplasm * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Ureteric cancer * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Uterine cancer * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Uterine leiomyoma * 1     
# participants affected / at risk   2/4814 (0.04%)   4/4852 (0.08%) 
Vulval cancer * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Nervous system disorders     
Alcoholic seizure * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Aphasia * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Apraxia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Ataxia * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Carotid artery stenosis * 1     
# participants affected / at risk   0/4814 (0.00%)   3/4852 (0.06%) 
Carotid artery thrombosis * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Carpal tunnel syndrome * 1     
# participants affected / at risk   2/4814 (0.04%)   3/4852 (0.06%) 
Cerebellar infarction * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Cerebral artery thrombosis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Cerebral haemorrhage * 1     
# participants affected / at risk   3/4814 (0.06%)   3/4852 (0.06%) 
Cerebral infarction * 1     
# participants affected / at risk   3/4814 (0.06%)   6/4852 (0.12%) 
Cerebral ischaemia * 1     
# participants affected / at risk   2/4814 (0.04%)   5/4852 (0.10%) 
Cerebrovascular accident * 1     
# participants affected / at risk   20/4814 (0.42%)   26/4852 (0.54%) 
Cerebrovascular disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cervicobrachial syndrome * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Coma * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Coma hepatic * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Convulsion * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Dementia * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Dementia Alzheimer’s type * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Depressed level of consciousness * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Dizziness * 1     
# participants affected / at risk   5/4814 (0.10%)   4/4852 (0.08%) 
Drop attacks * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Dyskinesia * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Encephalopathy * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Epilepsy * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Extrapyramidal disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Facial paresis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Grand mal convulsion * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Headache * 1     
# participants affected / at risk   5/4814 (0.10%)   5/4852 (0.10%) 
Hemiparesis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Hypoaesthesia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
IIIrd nerve paresis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Ischaemic stroke * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Loss of consciousness * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Mental impairment * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Migraine * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Myelitis transverse * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Myelopathy * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Nervous system disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Neuralgia * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Neuritis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Neurological symptom * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Paraesthesia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Partial seizures * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Sciatica * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Sedation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Sensory disturbance * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Somnolence * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Spinal cord compression * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Subarachnoid haemorrhage * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Syncope * 1     
# participants affected / at risk   12/4814 (0.25%)   13/4852 (0.27%) 
Thalamic infarction * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Transient ischaemic attack * 1     
# participants affected / at risk   11/4814 (0.23%)   11/4852 (0.23%) 
Psychiatric disorders     
Alcohol abuse * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Anxiety * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Bipolar I disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Completed suicide * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Confusional state * 1     
# participants affected / at risk   2/4814 (0.04%)   4/4852 (0.08%) 
Delirium * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Depression * 1     
# participants affected / at risk   10/4814 (0.21%)   9/4852 (0.19%) 
Depression suicidal * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Emotional distress * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Major depression * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Mental disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Mood altered * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Suicidal ideation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Suicide attempt * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Renal and urinary disorders     
Bladder prolapse * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Calculus bladder * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Dysuria * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Haematuria * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Haemorrhage urinary tract * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hydronephrosis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Incontinence * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Nephrolithiasis * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Renal artery stenosis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Renal colic * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Renal disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Renal failure * 1     
# participants affected / at risk   4/4814 (0.08%)   7/4852 (0.14%) 
Renal failure acute * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Renal infarct * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Stress urinary incontinence * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Ureteric obstruction * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Urinary bladder polyp * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Urinary incontinence * 1     
# participants affected / at risk   1/4814 (0.02%)   4/4852 (0.08%) 
Urinary retention * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Urogenital disorder * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Reproductive system and breast disorders     
Breast calcifications * 1     
# participants affected / at risk   4/4814 (0.08%)   4/4852 (0.08%) 
Breast cyst * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Breast disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   7/4852 (0.14%) 
Breast enlargement * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Breast fibrosis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Breast haematoma * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Breast hyperplasia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Breast mass * 1     
# participants affected / at risk   3/4814 (0.06%)   4/4852 (0.08%) 
Breast necrosis * 1     
# participants affected / at risk   0/4814 (0.00%)   4/4852 (0.08%) 
Cervical dysplasia * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Cervical polyp * 1     
# participants affected / at risk   4/4814 (0.08%)   0/4852 (0.00%) 
Cystocele * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Endometrial atrophy * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Endometrial disorder * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Endometrial hyperplasia * 1     
# participants affected / at risk   17/4814 (0.35%)   0/4852 (0.00%) 
Endometrial hypertrophy * 1     
# participants affected / at risk   3/4814 (0.06%)   0/4852 (0.00%) 
Female genital tract fistula * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Fibrocystic breast disease * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Genital prolapse * 1     
# participants affected / at risk   3/4814 (0.06%)   0/4852 (0.00%) 
Menorrhagia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Menstruation irregular * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Metrorrhagia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Nipple disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Ovarian cyst * 1     
# participants affected / at risk   6/4814 (0.12%)   4/4852 (0.08%) 
Ovarian disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Pelvic pain * 1     
# participants affected / at risk   3/4814 (0.06%)   1/4852 (0.02%) 
Postmenopausal haemorrhage * 1     
# participants affected / at risk   3/4814 (0.06%)   1/4852 (0.02%) 
Rectocele * 1     
# participants affected / at risk   3/4814 (0.06%)   1/4852 (0.02%) 
Urogenital prolapse * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Uterine atony * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Uterine disorder * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Uterine haemorrhage * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Uterine polyp * 1     
# participants affected / at risk   12/4814 (0.25%)   1/4852 (0.02%) 
Uterine prolapse * 1     
# participants affected / at risk   5/4814 (0.10%)   1/4852 (0.02%) 
Vaginal disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Vaginal haemorrhage * 1     
# participants affected / at risk   9/4814 (0.19%)   4/4852 (0.08%) 
Vaginal polyp * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Vaginal prolapse * 1     
# participants affected / at risk   3/4814 (0.06%)   1/4852 (0.02%) 
Vulval disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Vulval oedema * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Vulvovaginal disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Acute respiratory failure * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Apnoea * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Aspiration * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Asthma * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Atelectasis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Bronchial obstruction * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Bronchitis chronic * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Chronic obstructive pulmonary disease * 1     
# participants affected / at risk   4/4814 (0.08%)   2/4852 (0.04%) 
Cough * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Diaphragmatic disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Dyspnoea * 1     
# participants affected / at risk   13/4814 (0.27%)   28/4852 (0.58%) 
Dyspnoea exertional * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Emphysema * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Eosinophilic pneumonia * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Epistaxis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Haemoptysis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hypoxia * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Lung disorder * 1     
# participants affected / at risk   5/4814 (0.10%)   7/4852 (0.14%) 
Lung infiltration * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Nasal septum deviation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Nasal turbinate hypertrophy * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Obstructive airways disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Paranasal cyst * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Pleural effusion * 1     
# participants affected / at risk   2/4814 (0.04%)   7/4852 (0.14%) 
Pleurisy * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Pleuritic pain * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Pneumonitis * 1     
# participants affected / at risk   0/4814 (0.00%)   4/4852 (0.08%) 
Pneumothorax * 1     
# participants affected / at risk   3/4814 (0.06%)   2/4852 (0.04%) 
Productive cough * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Pulmonary congestion * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Pulmonary embolism * 1     
# participants affected / at risk   22/4814 (0.46%)   24/4852 (0.49%) 
Pulmonary hypertension * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Pulmonary mass * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Pulmonary oedema * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Respiratory disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Respiratory distress * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Respiratory failure * 1     
# participants affected / at risk   1/4814 (0.02%)   4/4852 (0.08%) 
Sinus disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Skin and subcutaneous tissue disorders     
Acute febrile neutrophilic dermatosis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Dermatitis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Dermatitis allergic * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Eczema * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Nail disorder * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Panniculitis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Pruritus * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Rash * 1     
# participants affected / at risk   3/4814 (0.06%)   3/4852 (0.06%) 
Scar * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Skin disorder * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Skin lesion * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Skin necrosis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Skin ulcer * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Urticaria * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Surgical and medical procedures     
Alcohol detoxification * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Angioplasty * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Aortic valve replacement * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Arterial bypass operation * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Bile duct stent insertion * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Breast lump removal * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Breast operation * 1     
# participants affected / at risk   2/4814 (0.04%)   2/4852 (0.04%) 
Breast reconstruction * 1     
# participants affected / at risk   3/4814 (0.06%)   2/4852 (0.04%) 
Bunion operation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cardiac pacemaker insertion * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Cardiac pacemaker replacement * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Carpal tunnel decompression * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cast application * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Cataract operation * 1     
# participants affected / at risk   3/4814 (0.06%)   2/4852 (0.04%) 
Cholecystectomy * 1     
# participants affected / at risk   5/4814 (0.10%)   4/4852 (0.08%) 
Cholelithotomy * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Colporrhaphy * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Coronary arterial stent insertion * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Coronary artery bypass * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Drug therapy * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Eventration procedure * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Female genital operation * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Gastric bypass * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Gastric operation * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Haemangioma removal * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Hernia repair * 1     
# participants affected / at risk   0/4814 (0.00%)   3/4852 (0.06%) 
Hip arthroplasty * 1     
# participants affected / at risk   4/4814 (0.08%)   10/4852 (0.21%) 
Hip surgery * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Hospitalisation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Hysterectomy * 1     
# participants affected / at risk   3/4814 (0.06%)   1/4852 (0.02%) 
Inguinal hernia repair * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Intervertebral disc operation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Joint arthroplasty * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Knee arthroplasty * 1     
# participants affected / at risk   7/4814 (0.15%)   4/4852 (0.08%) 
Knee operation * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Lipoma excision * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Mastectomy * 1     
# participants affected / at risk   4/4814 (0.08%)   1/4852 (0.02%) 
Medical device removal * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Meniscus operation * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Meniscus removal * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Oophorectomy * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Osteosynthesis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Phlebectomy * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Prolapse repair * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Radical hysterectomy * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Retinal operation * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Rotator cuff repair * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Scar excision * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Shoulder arthroplasty * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Simple mastectomy * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Skin neoplasm excision * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Spinal laminectomy * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Surgery * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Tendon operation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Thyroid nodule removal * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Thyroidectomy * 1     
# participants affected / at risk   0/4814 (0.00%)   5/4852 (0.10%) 
Toe amputation * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Toe operation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Uterine dilation and curettage * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Uterine prolapse repair * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Vaginal operation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Varicose vein operation * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Vascular operation * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Vascular disorders     
Aneurysm * 1     
# participants affected / at risk   0/4814 (0.00%)   4/4852 (0.08%) 
Aortic aneurysm * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Aortic stenosis * 1     
# participants affected / at risk   2/4814 (0.04%)   5/4852 (0.10%) 
Arterial occlusive disease * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Arteriosclerosis * 1     
# participants affected / at risk   1/4814 (0.02%)   2/4852 (0.04%) 
Arteritis * 1     
# participants affected / at risk   1/4814 (0.02%)   1/4852 (0.02%) 
Circulatory collapse * 1     
# participants affected / at risk   1/4814 (0.02%)   3/4852 (0.06%) 
Deep vein thrombosis * 1     
# participants affected / at risk   14/4814 (0.29%)   6/4852 (0.12%) 
Embolism * 1     
# participants affected / at risk   4/4814 (0.08%)   2/4852 (0.04%) 
Femoral arterial stenosis * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Femoral artery occlusion * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Flushing * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Haematoma * 1     
# participants affected / at risk   3/4814 (0.06%)   0/4852 (0.00%) 
Haemorrhage * 1     
# participants affected / at risk   2/4814 (0.04%)   1/4852 (0.02%) 
Hot flush * 1     
# participants affected / at risk   2/4814 (0.04%)   0/4852 (0.00%) 
Hypertension * 1     
# participants affected / at risk   6/4814 (0.12%)   11/4852 (0.23%) 
Hypertensive crisis * 1     
# participants affected / at risk   0/4814 (0.00%)   8/4852 (0.16%) 
Hypotension * 1     
# participants affected / at risk   0/4814 (0.00%)   2/4852 (0.04%) 
Intermittent claudication * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Ischaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Lymphoedema * 1     
# participants affected / at risk   0/4814 (0.00%)   3/4852 (0.06%) 
Peripheral arterial occlusive disease * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Peripheral ischaemia * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Peripheral vascular disorder * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Phlebitis * 1     
# participants affected / at risk   8/4814 (0.17%)   2/4852 (0.04%) 
Shock * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Thrombophlebitis * 1     
# participants affected / at risk   5/4814 (0.10%)   0/4852 (0.00%) 
Thrombosis * 1     
# participants affected / at risk   13/4814 (0.27%)   6/4852 (0.12%) 
Varicophlebitis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Varicose vein * 1     
# participants affected / at risk   1/4814 (0.02%)   7/4852 (0.14%) 
Vasculitis * 1     
# participants affected / at risk   1/4814 (0.02%)   0/4852 (0.00%) 
Venoocclusive disease * 1     
# participants affected / at risk   0/4814 (0.00%)   1/4852 (0.02%) 
Venous thrombosis * 1     
# participants affected / at risk   6/4814 (0.12%)   2/4852 (0.04%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 14.0




  Other Adverse Events


  Limitations and Caveats
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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
Overall Survival was reported as number of events which otherwise reported as time.


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