Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00753272
First received: September 12, 2008
Last updated: May 14, 2015
Last verified: September 2014
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Results First Received: April 26, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Condition: |
Influenza |
| Interventions: |
Biological: GSK Bio's influenza vaccine GSK2186877A Biological: Fluarix TM |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Subjects were vaccinated during the pre-influenza season at Day 0, were contacted by phone during the surveillance period from mid November to the end of the influenza season (April-May) and were contacted by phone at Days 270 and 365 for the Year 1 influenza season 2008/2009 and the Year 2 influenza season 2009/2010. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| For lot-to-lot consistency analyses after Dose 1 at Day 0 of the Year 1, FluNG Group was divided in 3 sub-groups: FluNG Lot 1 Group, FluNG Lot 2 Group and FluNG Lot 3 Group: subjects received 1 dose of FluNG vaccine Lot 1, 2 or 3 at Day 0 of the Year 1. They all received Dose 2 at Day 0 of the Year 2, again from 3 different lots. |
Reporting Groups
| Description | |
|---|---|
| FluNG Group | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Fluarix Group | subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
Participant Flow: Overall Study
| FluNG Group | Fluarix Group | |
|---|---|---|
| STARTED | 21893 | 21802 |
| COMPLETED | 16911 | 16895 |
| NOT COMPLETED | 4982 | 4907 |
| Adverse Event | 878 | 869 |
| Protocol Violation | 28 | 46 |
| Withdrawal by Subject | 2481 | 2407 |
| Lost to Follow-up | 491 | 497 |
| Unspecified | 1104 | 1088 |
Baseline Characteristics
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 | |
|---|---|
| FluNG Group | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Fluarix Group | subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Total | Total of all reporting groups |
Baseline Measures
| FluNG Group | Fluarix Group | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
21893 | 21802 | 43695 |
|
Age
[units: Years] Mean (Standard Deviation) |
|||
| Years | 73.5 (6.09) | 73.5 (6.16) | 73.5 (6.13) |
|
Gender
[units: Subjects] |
|||
| Female | 12549 | 12422 | 24971 |
| Male | 9344 | 9380 | 18724 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. [ Time Frame: After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season)) ] |
| 2. Primary: | Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. [ Time Frame: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study ] |
| 3. Secondary: | Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. [ Time Frame: During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010) ] |
| 4. Secondary: | Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection. [ Time Frame: During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010) ] |
| 5. Secondary: | Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine. [ Time Frame: During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) ] |
Hide Outcome Measure 5
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine. |
| Measure Description |
Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough. The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). |
| Time Frame | During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) |
| Safety Issue | No |
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. |
|---|
| The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season. |
Reporting Groups
| Description | |
|---|---|
| FluNG Group | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Fluarix Group | subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
Measured Values
| FluNG Group | Fluarix Group | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
21394 | 21337 |
|
Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.
[units: Subjects] |
202 | 225 |
No statistical analysis provided for Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.
| 6. Secondary: | Number of Subjects Reporting All-cause Death After the First Dose of Vaccine. [ Time Frame: During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) ] |
| 7. Secondary: | Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine [ Time Frame: During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) ] |
| 8. Secondary: | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). [ Time Frame: Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009) ] |
| 9. Secondary: | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). [ Time Frame: Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010) ] |
| 10. Secondary: | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). [ Time Frame: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) ] |
| 11. Secondary: | Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) ] |
| 12. Secondary: | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ] |
| 13. Secondary: | Number of Days With Any Grade of Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ] |
| 14. Secondary: | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ] |
| 15. Secondary: | Number of Days With Any Grade of Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ] |
| 16. Secondary: | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ] |
| 17. Secondary: | Number of Days With Any Grade of Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ] |
| 18. Secondary: | Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ] |
| 19. Secondary: | Number of Days With Any Grade of Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ] |
| 20. Secondary: | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). [ Time Frame: Within 21 days (Days 0-20) after the first dose (Year 2008/2009) ] |
| 21. Secondary: | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). [ Time Frame: Within 21 days (Days 0-20) after the second dose (Year 2009/2010) ] |
| 22. Secondary: | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit [ Time Frame: Within 180 days (Days 0-179) after the first dose (Year 2008/2009) ] |
| 23. Secondary: | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit. [ Time Frame: Within 180 days (Days 0-179) after the second dose (Year 2009/2010) ] |
| 24. Secondary: | Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. [ Time Frame: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study ] |
| 25. Secondary: | Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains [ Time Frame: At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study ] |
| 26. Secondary: | Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. [ Time Frame: At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study ] |
| 27. Secondary: | Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. [ Time Frame: At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study ] |
| 28. Secondary: | Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains [ Time Frame: At Day 21 of the first year (2008/2009) of the study. ] |
Serious Adverse Events| Time Frame | Solicited symptoms: During the 7-day post-vaccination period the first year (2008/2009) and the second year (2009/2010). SAEs: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| FluNG Group | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Fluarix Group | subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
Serious Adverse Events
| FluNG Group | Fluarix Group | |
|---|---|---|
| Total, serious adverse events | ||
| # participants affected / at risk | 4071/21893 (18.59%) | 4066/21802 (18.65%) |
| Blood and lymphatic system disorders | ||
| Anaemia * | ||
| # participants affected / at risk | 48/21893 (0.22%) | 64/21802 (0.29%) |
| Iron deficiency anaemia * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 14/21802 (0.06%) |
| Haemorrhagic anaemia * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Thrombocytopenia * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 2/21802 (0.01%) |
| Cardiac disorders | ||
| Atrial fibrillation * | ||
| # participants affected / at risk | 211/21893 (0.96%) | 178/21802 (0.82%) |
| Myocardial infarction * | ||
| # participants affected / at risk | 169/21893 (0.77%) | 167/21802 (0.77%) |
| Cardiac failure congestive * | ||
| # participants affected / at risk | 147/21893 (0.67%) | 153/21802 (0.70%) |
| Cardiac failure * | ||
| # participants affected / at risk | 98/21893 (0.45%) | 102/21802 (0.47%) |
| Coronary artery disease * | ||
| # participants affected / at risk | 90/21893 (0.41%) | 75/21802 (0.34%) |
| Angina pectoris * | ||
| # participants affected / at risk | 77/21893 (0.35%) | 75/21802 (0.34%) |
| Myocardial ischaemia * | ||
| # participants affected / at risk | 64/21893 (0.29%) | 62/21802 (0.28%) |
| Acute myocardial infarction * | ||
| # participants affected / at risk | 38/21893 (0.17%) | 59/21802 (0.27%) |
| Arrhythmia * | ||
| # participants affected / at risk | 35/21893 (0.16%) | 26/21802 (0.12%) |
| Cardiac arrest * | ||
| # participants affected / at risk | 33/21893 (0.15%) | 28/21802 (0.13%) |
| Bradycardia * | ||
| # participants affected / at risk | 18/21893 (0.08%) | 20/21802 (0.09%) |
| Angina unstable * | ||
| # participants affected / at risk | 17/21893 (0.08%) | 18/21802 (0.08%) |
| Atrial flutter * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 16/21802 (0.07%) |
| Atrioventricular block * | ||
| # participants affected / at risk | 11/21893 (0.05%) | 16/21802 (0.07%) |
| Acute coronary syndrome * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 18/21802 (0.08%) |
| Mitral valve incompetence * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 10/21802 (0.05%) |
| Aortic valve stenosis * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 8/21802 (0.04%) |
| Sick sinus syndrome * | ||
| # participants affected / at risk | 10/21893 (0.05%) | 11/21802 (0.05%) |
| Atrioventricular block complete * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 11/21802 (0.05%) |
| Supraventricular tachycardia * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 13/21802 (0.06%) |
| Left ventricular failure * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 8/21802 (0.04%) |
| Tachyarrhythmia * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 8/21802 (0.04%) |
| Coronary artery stenosis * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 9/21802 (0.04%) |
| Arrhythmia supraventricular * | ||
| # participants affected / at risk | 11/21893 (0.05%) | 4/21802 (0.02%) |
| Ventricular fibrillation * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 7/21802 (0.03%) |
| Cardiopulmonary failure * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 6/21802 (0.03%) |
| Arteriosclerosis coronary artery * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 6/21802 (0.03%) |
| Cardiac failure chronic * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 5/21802 (0.02%) |
| Cardio-respiratory arrest * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 7/21802 (0.03%) |
| Cardiovascular insufficiency * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 6/21802 (0.03%) |
| Coronary artery occlusion * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 6/21802 (0.03%) |
| Cardiac failure acute * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 5/21802 (0.02%) |
| Atrioventricular block second degree * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 2/21802 (0.01%) |
| Ventricular tachycardia * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 6/21802 (0.03%) |
| Aortic valve incompetence * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 6/21802 (0.03%) |
| Cardiogenic shock * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 2/21802 (0.01%) |
| Tachycardia * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 5/21802 (0.02%) |
| Ventricular extrasystoles * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 4/21802 (0.02%) |
| Coronary artery insufficiency * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 5/21802 (0.02%) |
| Hypertensive heart disease * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Pericarditis * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 5/21802 (0.02%) |
| Congenital, familial and genetic disorders | ||
| Gastrointestinal angiodysplasia * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Ear and labyrinth disorders | ||
| Vertigo * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 19/21802 (0.09%) |
| Vestibular disorder * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 8/21802 (0.04%) |
| Vertigo positional * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 8/21802 (0.04%) |
| Endocrine disorders | ||
| Hypothyroidism * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 7/21802 (0.03%) |
| Hyperthyroidism * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 9/21802 (0.04%) |
| Goitre * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 3/21802 (0.01%) |
| Eye disorders | ||
| Cataract * | ||
| # participants affected / at risk | 16/21893 (0.07%) | 20/21802 (0.09%) |
| Glaucoma * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 8/21802 (0.04%) |
| Retinal detachment * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 6/21802 (0.03%) |
| Gastrointestinal disorders | ||
| Inguinal hernia * | ||
| # participants affected / at risk | 37/21893 (0.17%) | 26/21802 (0.12%) |
| Gastrointestinal haemorrhage * | ||
| # participants affected / at risk | 19/21893 (0.09%) | 29/21802 (0.13%) |
| Gastritis * | ||
| # participants affected / at risk | 20/21893 (0.09%) | 22/21802 (0.10%) |
| Pancreatitis acute * | ||
| # participants affected / at risk | 18/21893 (0.08%) | 18/21802 (0.08%) |
| Gastric ulcer * | ||
| # participants affected / at risk | 16/21893 (0.07%) | 18/21802 (0.08%) |
| Intestinal obstruction * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 19/21802 (0.09%) |
| Pancreatitis * | ||
| # participants affected / at risk | 18/21893 (0.08%) | 11/21802 (0.05%) |
| Ileus * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 11/21802 (0.05%) |
| Small intestinal obstruction * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 12/21802 (0.06%) |
| Constipation * | ||
| # participants affected / at risk | 11/21893 (0.05%) | 13/21802 (0.06%) |
| Duodenal ulcer * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 8/21802 (0.04%) |
| Peritonitis * | ||
| # participants affected / at risk | 12/21893 (0.05%) | 11/21802 (0.05%) |
| Colitis * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 14/21802 (0.06%) |
| Abdominal pain * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 7/21802 (0.03%) |
| Colonic polyp * | ||
| # participants affected / at risk | 11/21893 (0.05%) | 9/21802 (0.04%) |
| Upper gastrointestinal haemorrhage * | ||
| # participants affected / at risk | 11/21893 (0.05%) | 9/21802 (0.04%) |
| Diarrhoea * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 9/21802 (0.04%) |
| Gastritis erosive * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 8/21802 (0.04%) |
| Gastrooesophageal reflux disease * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 10/21802 (0.05%) |
| Diverticulum * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 9/21802 (0.04%) |
| Gastric ulcer haemorrhage * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 9/21802 (0.04%) |
| Hiatus hernia * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 11/21802 (0.05%) |
| Colitis ischaemic * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 11/21802 (0.05%) |
| Large intestine perforation * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 5/21802 (0.02%) |
| Dyspepsia * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 8/21802 (0.04%) |
| Haemorrhoids * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 5/21802 (0.02%) |
| Rectal haemorrhage * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 7/21802 (0.03%) |
| Reflux oesophagitis * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 9/21802 (0.04%) |
| Dysphagia * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 7/21802 (0.03%) |
| Faecaloma * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 6/21802 (0.03%) |
| Lower gastrointestinal haemorrhage * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 8/21802 (0.04%) |
| Abdominal hernia * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 3/21802 (0.01%) |
| Oesophagitis * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 4/21802 (0.02%) |
| Pancreatitis chronic * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 3/21802 (0.01%) |
| Umbilical hernia * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 5/21802 (0.02%) |
| Diverticular perforation * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 6/21802 (0.03%) |
| Diverticulum intestinal * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 2/21802 (0.01%) |
| Peptic ulcer * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 3/21802 (0.01%) |
| Vomiting * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 3/21802 (0.01%) |
| Duodenitis * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Gastric haemorrhage * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 2/21802 (0.01%) |
| Nausea * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 2/21802 (0.01%) |
| Oesophageal stenosis * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Gastroduodenal ulcer * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 2/21802 (0.01%) |
| Haematochezia * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Ileus paralytic * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 1/21802 (0.00%) |
| Intestinal polyp * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 1/21802 (0.00%) |
| Oesophageal varices haemorrhage * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| General disorders | ||
| Chest pain * | ||
| # participants affected / at risk | 42/21893 (0.19%) | 45/21802 (0.21%) |
| Death * | ||
| # participants affected / at risk | 28/21893 (0.13%) | 27/21802 (0.12%) |
| Sudden death * | ||
| # participants affected / at risk | 34/21893 (0.16%) | 18/21802 (0.08%) |
| Multi-organ failure * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 15/21802 (0.07%) |
| Cardiac death * | ||
| # participants affected / at risk | 11/21893 (0.05%) | 8/21802 (0.04%) |
| Sudden cardiac death * | ||
| # participants affected / at risk | 12/21893 (0.05%) | 7/21802 (0.03%) |
| Non-cardiac chest pain * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 8/21802 (0.04%) |
| Asthenia * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 3/21802 (0.01%) |
| Pyrexia * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 5/21802 (0.02%) |
| Device dislocation * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 5/21802 (0.02%) |
| Oedema peripheral * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Pain * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Hepatobiliary disorders | ||
| Cholelithiasis * | ||
| # participants affected / at risk | 44/21893 (0.20%) | 45/21802 (0.21%) |
| Cholecystitis * | ||
| # participants affected / at risk | 40/21893 (0.18%) | 43/21802 (0.20%) |
| Cholecystitis acute * | ||
| # participants affected / at risk | 23/21893 (0.11%) | 17/21802 (0.08%) |
| Bile duct stone * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 9/21802 (0.04%) |
| Hepatic cirrhosis * | ||
| # participants affected / at risk | 11/21893 (0.05%) | 9/21802 (0.04%) |
| Cholangitis * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 5/21802 (0.02%) |
| Biliary colic * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Immune system disorders | ||
| Hypersensitivity * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 5/21802 (0.02%) |
| Anaphylactic reaction * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Infections and infestations | ||
| Pneumonia * | ||
| # participants affected / at risk | 228/21893 (1.04%) | 226/21802 (1.04%) |
| Urinary tract infection * | ||
| # participants affected / at risk | 129/21893 (0.59%) | 111/21802 (0.51%) |
| Sepsis * | ||
| # participants affected / at risk | 41/21893 (0.19%) | 45/21802 (0.21%) |
| Gastroenteritis * | ||
| # participants affected / at risk | 35/21893 (0.16%) | 47/21802 (0.22%) |
| Diverticulitis * | ||
| # participants affected / at risk | 31/21893 (0.14%) | 34/21802 (0.16%) |
| Cellulitis * | ||
| # participants affected / at risk | 29/21893 (0.13%) | 27/21802 (0.12%) |
| Bronchopneumonia * | ||
| # participants affected / at risk | 26/21893 (0.12%) | 29/21802 (0.13%) |
| Erysipelas * | ||
| # participants affected / at risk | 28/21893 (0.13%) | 21/21802 (0.10%) |
| Lobar pneumonia * | ||
| # participants affected / at risk | 16/21893 (0.07%) | 19/21802 (0.09%) |
| Pyelonephritis * | ||
| # participants affected / at risk | 21/21893 (0.10%) | 13/21802 (0.06%) |
| Appendicitis * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 17/21802 (0.08%) |
| Upper respiratory tract infection * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 17/21802 (0.08%) |
| Septic shock * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 18/21802 (0.08%) |
| Gangrene * | ||
| # participants affected / at risk | 10/21893 (0.05%) | 11/21802 (0.05%) |
| Cystitis * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 12/21802 (0.06%) |
| Herpes zoster * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 9/21802 (0.04%) |
| Respiratory tract infection * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 9/21802 (0.04%) |
| Wound infection * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 7/21802 (0.03%) |
| Staphylococcal infection * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 5/21802 (0.02%) |
| Urosepsis * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 4/21802 (0.02%) |
| Sinusitis * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 7/21802 (0.03%) |
| Osteomyelitis * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 7/21802 (0.03%) |
| Clostridial infection * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 6/21802 (0.03%) |
| Clostridium difficile colitis * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 3/21802 (0.01%) |
| Infection * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 6/21802 (0.03%) |
| Candidiasis * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 2/21802 (0.01%) |
| Cholecystitis infective * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Gastroenteritis norovirus * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Gastroenteritis viral * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Escherichia urinary tract infection * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 0/21802 (0.00%) |
| Infected skin ulcer * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Infective exacerbation of chronic obstructive airways diseas * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Localised infection * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Lower respiratory tract infection * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Lung infection * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 5/21802 (0.02%) |
| Pharyngitis * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Postoperative wound infection * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Pyelonephritis acute * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 2/21802 (0.01%) |
| Injury, poisoning and procedural complications | ||
| Femoral neck fracture * | ||
| # participants affected / at risk | 35/21893 (0.16%) | 53/21802 (0.24%) |
| Femur fracture * | ||
| # participants affected / at risk | 34/21893 (0.16%) | 45/21802 (0.21%) |
| Hip fracture * | ||
| # participants affected / at risk | 23/21893 (0.11%) | 34/21802 (0.16%) |
| Humerus fracture * | ||
| # participants affected / at risk | 19/21893 (0.09%) | 35/21802 (0.16%) |
| Rib fracture * | ||
| # participants affected / at risk | 21/21893 (0.10%) | 14/21802 (0.06%) |
| Toxicity to various agents * | ||
| # participants affected / at risk | 17/21893 (0.08%) | 18/21802 (0.08%) |
| Radius fracture * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 20/21802 (0.09%) |
| Contusion * | ||
| # participants affected / at risk | 20/21893 (0.09%) | 12/21802 (0.06%) |
| Ankle fracture * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 15/21802 (0.07%) |
| Concussion * | ||
| # participants affected / at risk | 10/21893 (0.05%) | 16/21802 (0.07%) |
| Upper limb fracture * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 17/21802 (0.08%) |
| Spinal compression fracture * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 11/21802 (0.05%) |
| Wrist fracture * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 10/21802 (0.05%) |
| Pelvic fracture * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 11/21802 (0.05%) |
| Subdural haematoma * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 15/21802 (0.07%) |
| Lumbar vertebral fracture * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 10/21802 (0.05%) |
| Road traffic accident * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 9/21802 (0.04%) |
| Facial bones fracture * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 8/21802 (0.04%) |
| Head injury * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 8/21802 (0.04%) |
| Joint dislocation * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 11/21802 (0.05%) |
| Spinal fracture * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 9/21802 (0.04%) |
| Laceration * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 6/21802 (0.03%) |
| Lower limb fracture * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 6/21802 (0.03%) |
| Fall * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 9/21802 (0.04%) |
| Tendon rupture * | ||
| # participants affected / at risk | 10/21893 (0.05%) | 3/21802 (0.01%) |
| Fibula fracture * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 4/21802 (0.02%) |
| Tibia fracture * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 8/21802 (0.04%) |
| Traumatic brain injury * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 5/21802 (0.02%) |
| Cervical vertebral fracture * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 4/21802 (0.02%) |
| Hand fracture * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 5/21802 (0.02%) |
| Meniscus lesion * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 8/21802 (0.04%) |
| Foot fracture * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 3/21802 (0.01%) |
| Forearm fracture * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 1/21802 (0.00%) |
| Brain contusion * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 5/21802 (0.02%) |
| Multiple injuries * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Overdose * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Pubis fracture * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 6/21802 (0.03%) |
| Thoracic vertebral fracture * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Ulna fracture * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Injury * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Multiple fractures * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Post procedural haemorrhage * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 5/21802 (0.02%) |
| Metabolism and nutrition disorders | ||
| Dehydration * | ||
| # participants affected / at risk | 24/21893 (0.11%) | 25/21802 (0.11%) |
| Diabetes mellitus inadequate control * | ||
| # participants affected / at risk | 22/21893 (0.10%) | 20/21802 (0.09%) |
| Hypoglycaemia * | ||
| # participants affected / at risk | 23/21893 (0.11%) | 18/21802 (0.08%) |
| Diabetes mellitus * | ||
| # participants affected / at risk | 18/21893 (0.08%) | 18/21802 (0.08%) |
| Type 2 diabetes mellitus * | ||
| # participants affected / at risk | 16/21893 (0.07%) | 12/21802 (0.06%) |
| Hyponatraemia * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 11/21802 (0.05%) |
| Hypokalaemia * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 9/21802 (0.04%) |
| Diabetic foot * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 7/21802 (0.03%) |
| Hyperkalaemia * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 5/21802 (0.02%) |
| Hypercholesterolaemia * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Hyperglycaemia * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 2/21802 (0.01%) |
| Cachexia * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Electrolyte imbalance * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Gout * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 0/21802 (0.00%) |
| Hypomagnesaemia * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 5/21802 (0.02%) |
| Musculoskeletal and connective tissue disorders | ||
| Osteoarthritis * | ||
| # participants affected / at risk | 87/21893 (0.40%) | 108/21802 (0.50%) |
| Intervertebral disc protrusion * | ||
| # participants affected / at risk | 18/21893 (0.08%) | 26/21802 (0.12%) |
| Back pain * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 20/21802 (0.09%) |
| Spinal column stenosis * | ||
| # participants affected / at risk | 19/21893 (0.09%) | 14/21802 (0.06%) |
| Rotator cuff syndrome * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 12/21802 (0.06%) |
| Arthralgia * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 12/21802 (0.06%) |
| Polymyalgia rheumatica * | ||
| # participants affected / at risk | 12/21893 (0.05%) | 5/21802 (0.02%) |
| Intervertebral disc degeneration * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 10/21802 (0.05%) |
| Lumbar spinal stenosis * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 9/21802 (0.04%) |
| Rheumatoid arthritis * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 8/21802 (0.04%) |
| Spinal osteoarthritis * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 8/21802 (0.04%) |
| Arthritis * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 4/21802 (0.02%) |
| Bone pain * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 2/21802 (0.01%) |
| Osteonecrosis * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Foot deformity * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Intervertebral disc disorder * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 2/21802 (0.01%) |
| Musculoskeletal pain * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 0/21802 (0.00%) |
| Pain in extremity * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 2/21802 (0.01%) |
| Spondylolisthesis * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Prostate cancer * | ||
| # participants affected / at risk | 57/21893 (0.26%) | 60/21802 (0.28%) |
| Breast cancer * | ||
| # participants affected / at risk | 48/21893 (0.22%) | 46/21802 (0.21%) |
| Colon cancer * | ||
| # participants affected / at risk | 44/21893 (0.20%) | 35/21802 (0.16%) |
| Lung neoplasm malignant * | ||
| # participants affected / at risk | 24/21893 (0.11%) | 38/21802 (0.17%) |
| Bladder cancer * | ||
| # participants affected / at risk | 20/21893 (0.09%) | 19/21802 (0.09%) |
| Basal cell carcinoma * | ||
| # participants affected / at risk | 12/21893 (0.05%) | 21/21802 (0.10%) |
| Gastric cancer * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 13/21802 (0.06%) |
| Pancreatic carcinoma * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 12/21802 (0.06%) |
| Rectal cancer * | ||
| # participants affected / at risk | 10/21893 (0.05%) | 13/21802 (0.06%) |
| Bladder neoplasm * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 9/21802 (0.04%) |
| Squamous cell carcinoma * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 9/21802 (0.04%) |
| Malignant melanoma * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 7/21802 (0.03%) |
| Renal cancer * | ||
| # participants affected / at risk | 10/21893 (0.05%) | 6/21802 (0.03%) |
| Hepatic neoplasm malignant * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 7/21802 (0.03%) |
| Pancreatic carcinoma metastatic * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 8/21802 (0.04%) |
| Lung adenocarcinoma * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 7/21802 (0.03%) |
| Neoplasm malignant * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 5/21802 (0.02%) |
| Lymphoma * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 4/21802 (0.02%) |
| Thyroid cancer * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 5/21802 (0.02%) |
| Metastases to liver * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 6/21802 (0.03%) |
| Prostatic adenoma * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 5/21802 (0.02%) |
| Colon cancer metastatic * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 5/21802 (0.02%) |
| Brain neoplasm * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 5/21802 (0.02%) |
| Lung neoplasm * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 6/21802 (0.03%) |
| Transitional cell carcinoma * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 4/21802 (0.02%) |
| Uterine cancer * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 4/21802 (0.02%) |
| Bronchial carcinoma * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 5/21802 (0.02%) |
| Non-hodgkin’s lymphoma * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 3/21802 (0.01%) |
| Breast cancer metastatic * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 4/21802 (0.02%) |
| Chronic lymphocytic leukaemia * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 5/21802 (0.02%) |
| Colon neoplasm * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 5/21802 (0.02%) |
| Lung cancer metastatic * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 4/21802 (0.02%) |
| Oesophageal carcinoma * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 3/21802 (0.01%) |
| Renal neoplasm * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 2/21802 (0.01%) |
| Acute myeloid leukaemia * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 5/21802 (0.02%) |
| Adenocarcinoma * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Colon adenoma * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 5/21802 (0.02%) |
| Endometrial cancer * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Hepatic neoplasm * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 2/21802 (0.01%) |
| Metastatic malignant melanoma * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Metastatic neoplasm * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Multiple myeloma * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Prostate cancer metastatic * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 6/21802 (0.03%) |
| Renal cancer metastatic * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 6/21802 (0.03%) |
| Breast cancer recurrent * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 2/21802 (0.01%) |
| Meningioma * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Metastases to lung * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 5/21802 (0.02%) |
| Ovarian neoplasm * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Renal cell carcinoma * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 5/21802 (0.02%) |
| Nervous system disorders | ||
| Cerebrovascular accident * | ||
| # participants affected / at risk | 196/21893 (0.90%) | 180/21802 (0.83%) |
| Transient ischaemic attack * | ||
| # participants affected / at risk | 69/21893 (0.32%) | 57/21802 (0.26%) |
| Syncope * | ||
| # participants affected / at risk | 54/21893 (0.25%) | 43/21802 (0.20%) |
| Cerebrovascular disorder * | ||
| # participants affected / at risk | 24/21893 (0.11%) | 21/21802 (0.10%) |
| Ischaemic stroke * | ||
| # participants affected / at risk | 17/21893 (0.08%) | 28/21802 (0.13%) |
| Cerebral infarction * | ||
| # participants affected / at risk | 23/21893 (0.11%) | 11/21802 (0.05%) |
| Epilepsy * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 11/21802 (0.05%) |
| Carotid artery stenosis * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 10/21802 (0.05%) |
| Vascular dementia * | ||
| # participants affected / at risk | 12/21893 (0.05%) | 7/21802 (0.03%) |
| Cerebral ischaemia * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 9/21802 (0.04%) |
| Cerebral haemorrhage * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 4/21802 (0.02%) |
| Dementia * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 9/21802 (0.04%) |
| Dementia alzheimer’s type * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 4/21802 (0.02%) |
| Dizziness * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 8/21802 (0.04%) |
| Parkinson’s disease * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 5/21802 (0.02%) |
| Presyncope * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 4/21802 (0.02%) |
| Grand mal convulsion * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 8/21802 (0.04%) |
| Sciatica * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 5/21802 (0.02%) |
| Cerebral arteriosclerosis * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 4/21802 (0.02%) |
| Subarachnoid haemorrhage * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 4/21802 (0.02%) |
| Brain oedema * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 7/21802 (0.03%) |
| Haemorrhagic stroke * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 4/21802 (0.02%) |
| Vertebrobasilar insufficiency * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 5/21802 (0.02%) |
| Convulsion * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 5/21802 (0.02%) |
| Encephalopathy * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 2/21802 (0.01%) |
| Parkinsonism * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 1/21802 (0.00%) |
| Brain stem infarction * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Embolic stroke * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Vascular encephalopathy * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 4/21802 (0.02%) |
| Psychiatric disorders | ||
| Depression * | ||
| # participants affected / at risk | 24/21893 (0.11%) | 20/21802 (0.09%) |
| Completed suicide * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 7/21802 (0.03%) |
| Delirium * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 4/21802 (0.02%) |
| Confusional state * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 4/21802 (0.02%) |
| Renal and urinary disorders | ||
| Renal failure acute * | ||
| # participants affected / at risk | 60/21893 (0.27%) | 45/21802 (0.21%) |
| Renal failure chronic * | ||
| # participants affected / at risk | 27/21893 (0.12%) | 30/21802 (0.14%) |
| Renal failure * | ||
| # participants affected / at risk | 26/21893 (0.12%) | 27/21802 (0.12%) |
| Nephrolithiasis * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 20/21802 (0.09%) |
| Urinary retention * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 15/21802 (0.07%) |
| Haematuria * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 8/21802 (0.04%) |
| Calculus ureteric * | ||
| # participants affected / at risk | 10/21893 (0.05%) | 4/21802 (0.02%) |
| Urethral stenosis * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 10/21802 (0.05%) |
| Calculus bladder * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 5/21802 (0.02%) |
| Hydronephrosis * | ||
| # participants affected / at risk | 8/21893 (0.04%) | 3/21802 (0.01%) |
| Urinary bladder polyp * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 6/21802 (0.03%) |
| Calculus urinary * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 6/21802 (0.03%) |
| Cystitis haemorrhagic * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 3/21802 (0.01%) |
| Bladder neck obstruction * | ||
| # participants affected / at risk | 1/21893 (0.00%) | 5/21802 (0.02%) |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasia * | ||
| # participants affected / at risk | 27/21893 (0.12%) | 31/21802 (0.14%) |
| Uterine prolapse * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 3/21802 (0.01%) |
| Ovarian cyst * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 5/21802 (0.02%) |
| Prostatitis * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 4/21802 (0.02%) |
| Uterine polyp * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Respiratory, thoracic and mediastinal disorders | ||
| Chronic obstructive pulmonary disease * | ||
| # participants affected / at risk | 141/21893 (0.64%) | 128/21802 (0.59%) |
| Pulmonary embolism * | ||
| # participants affected / at risk | 47/21893 (0.21%) | 61/21802 (0.28%) |
| Bronchitis * | ||
| # participants affected / at risk | 61/21893 (0.28%) | 43/21802 (0.20%) |
| Respiratory failure * | ||
| # participants affected / at risk | 32/21893 (0.15%) | 37/21802 (0.17%) |
| Asthma * | ||
| # participants affected / at risk | 33/21893 (0.15%) | 17/21802 (0.08%) |
| Pulmonary oedema * | ||
| # participants affected / at risk | 19/21893 (0.09%) | 24/21802 (0.11%) |
| Acute respiratory failure * | ||
| # participants affected / at risk | 22/21893 (0.10%) | 15/21802 (0.07%) |
| Pleural effusion * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 19/21802 (0.09%) |
| Bronchitis chronic * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 14/21802 (0.06%) |
| Pneumonia aspiration * | ||
| # participants affected / at risk | 10/21893 (0.05%) | 14/21802 (0.06%) |
| Dyspnoea * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 10/21802 (0.05%) |
| Epistaxis * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 9/21802 (0.04%) |
| Pneumothorax * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 4/21802 (0.02%) |
| Acute pulmonary oedema * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 8/21802 (0.04%) |
| Emphysema * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 7/21802 (0.03%) |
| Pleurisy * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 3/21802 (0.01%) |
| Pulmonary fibrosis * | ||
| # participants affected / at risk | 2/21893 (0.01%) | 6/21802 (0.03%) |
| Sleep apnoea syndrome * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 5/21802 (0.02%) |
| Pulmonary hypertension * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 3/21802 (0.01%) |
| Bronchiectasis * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 1/21802 (0.00%) |
| Interstitial lung disease * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Respiratory arrest * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| Skin and subcutaneous tissue disorders | ||
| Decubitus ulcer * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 7/21802 (0.03%) |
| Skin ulcer * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 6/21802 (0.03%) |
| Angioedema * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 5/21802 (0.02%) |
| Vascular disorders | ||
| Hypertension * | ||
| # participants affected / at risk | 82/21893 (0.37%) | 83/21802 (0.38%) |
| Arteriosclerosis * | ||
| # participants affected / at risk | 22/21893 (0.10%) | 30/21802 (0.14%) |
| Hypertensive crisis * | ||
| # participants affected / at risk | 26/21893 (0.12%) | 21/21802 (0.10%) |
| Circulatory collapse * | ||
| # participants affected / at risk | 23/21893 (0.11%) | 18/21802 (0.08%) |
| Deep vein thrombosis * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 24/21802 (0.11%) |
| Peripheral arterial occlusive disease * | ||
| # participants affected / at risk | 19/21893 (0.09%) | 13/21802 (0.06%) |
| Aortic aneurysm * | ||
| # participants affected / at risk | 13/21893 (0.06%) | 15/21802 (0.07%) |
| Hypotension * | ||
| # participants affected / at risk | 14/21893 (0.06%) | 13/21802 (0.06%) |
| Haematoma * | ||
| # participants affected / at risk | 15/21893 (0.07%) | 8/21802 (0.04%) |
| Peripheral vascular disorder * | ||
| # participants affected / at risk | 11/21893 (0.05%) | 11/21802 (0.05%) |
| Aortic stenosis * | ||
| # participants affected / at risk | 11/21893 (0.05%) | 7/21802 (0.03%) |
| Venous thrombosis * | ||
| # participants affected / at risk | 9/21893 (0.04%) | 8/21802 (0.04%) |
| Thrombophlebitis * | ||
| # participants affected / at risk | 7/21893 (0.03%) | 5/21802 (0.02%) |
| Thrombosis * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 8/21802 (0.04%) |
| Orthostatic hypotension * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 6/21802 (0.03%) |
| Arterial occlusive disease * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 6/21802 (0.03%) |
| Intermittent claudication * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 6/21802 (0.03%) |
| Peripheral ischaemia * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 4/21802 (0.02%) |
| Arterial thrombosis limb * | ||
| # participants affected / at risk | 4/21893 (0.02%) | 4/21802 (0.02%) |
| Hypovolaemic shock * | ||
| # participants affected / at risk | 5/21893 (0.02%) | 2/21802 (0.01%) |
| Varicose vein * | ||
| # participants affected / at risk | 6/21893 (0.03%) | 1/21802 (0.00%) |
| Venous thrombosis limb * | ||
| # participants affected / at risk | 3/21893 (0.01%) | 3/21802 (0.01%) |
| * | Events were collected by non-systematic assessment |
|---|
Other Adverse Events
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 |
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