Trial Outcomes & Findings for A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention (NCT NCT00097591)
NCT ID: NCT00097591
Last Updated: 2010-09-16
Results Overview
The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
13619 participants
Primary outcome timeframe
Randomization up to 15 months
Results posted on
2010-09-16
Participant Flow
Acute Coronary Syndromes (ACS) includes subjects presenting with unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).
Participant milestones
| Measure |
Prasugrel
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Overall Study
STARTED
|
6813
|
6795
|
|
Overall Study
COMPLETED
|
6403
|
6401
|
|
Overall Study
NOT COMPLETED
|
410
|
394
|
Reasons for withdrawal
| Measure |
Prasugrel
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Overall Study
Withdrawal of consent
|
342
|
323
|
|
Overall Study
Less than 6 months on study drug
|
9
|
7
|
|
Overall Study
Unable to attend termination visit
|
53
|
51
|
|
Overall Study
Lost to follow up
|
6
|
10
|
|
Overall Study
Other
|
0
|
3
|
Baseline Characteristics
A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Baseline characteristics by cohort
| Measure |
Prasugrel
n=6813 Participants
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
n=6795 Participants
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
Total
n=13608 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.9 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1705 Participants
n=5 Participants
|
1818 Participants
n=7 Participants
|
3523 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5108 Participants
n=5 Participants
|
4977 Participants
n=7 Participants
|
10085 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6263 Participants
n=5 Participants
|
6274 Participants
n=7 Participants
|
12537 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
205 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
269 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
525 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
60 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
2164 participants
n=5 Participants
|
2146 participants
n=7 Participants
|
4310 participants
n=5 Participants
|
|
Region of Enrollment
South America
|
270 participants
n=5 Participants
|
264 participants
n=7 Participants
|
534 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
3436 participants
n=5 Participants
|
3439 participants
n=7 Participants
|
6875 participants
n=5 Participants
|
|
Region of Enrollment
Middle East
|
606 participants
n=5 Participants
|
613 participants
n=7 Participants
|
1219 participants
n=5 Participants
|
|
Region of Enrollment
Africa
|
204 participants
n=5 Participants
|
200 participants
n=7 Participants
|
404 participants
n=5 Participants
|
|
Region of Enrollment
Pacifica
|
133 participants
n=5 Participants
|
133 participants
n=7 Participants
|
266 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization up to 15 monthsPopulation: Intention-to-treat (ITT) population consisting of all subjects with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) who may or may not have received study drug
The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).
Outcome measures
| Measure |
Prasugrel
n=6813 Participants
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
n=6795 Participants
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
UA/NSTEMI (n=5044, n=5030)
|
469 Participants
|
565 Participants
|
|
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
STEMI (n=1769, n=1765)
|
174 Participants
|
216 Participants
|
|
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
All ACS (n=6813, n=6795)
|
643 Participants
|
781 Participants
|
SECONDARY outcome
Timeframe: First dose of study drug up to 15 months (while at risk)Population: Treated subjects with adverse events were considered "at risk" from the first dose of study drug up through 7 days after permanent study drug discontinuation, or the subjects' discontinuation visit; or from randomization through 464 days, whichever is earlier. Adverse events classified as "study drug related" were included in the "at risk" set.
TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 gm/dL but \<5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal.
Outcome measures
| Measure |
Prasugrel
n=6741 Participants
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
n=6716 Participants
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
TIMI Major or Minor Bleeding
|
303 Participants
|
231 Participants
|
|
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
TIMI Major Bleeding
|
146 Participants
|
111 Participants
|
|
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
TIMI Major Bleeding - Life-threatening (LT)
|
85 Participants
|
56 Participants
|
|
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
LT - Fatal
|
21 Participants
|
5 Participants
|
|
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
LT - Symptomatic intracranial hemorrage (ICH)
|
19 Participants
|
17 Participants
|
|
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
LT - Requiring inotropes
|
21 Participants
|
8 Participants
|
|
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
LT - Requiring surgical intervention
|
19 Participants
|
19 Participants
|
|
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
LT - Requiring transfusion (>=4 units)
|
45 Participants
|
30 Participants
|
|
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
TIMI Minor Bleeding
|
164 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: Randomization to 30 days; randomization to 90 daysPopulation: Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.
The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods.
Outcome measures
| Measure |
Prasugrel
n=6813 Participants
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
n=6795 Participants
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)
All ACS (Through 30 days)
|
399 Participants
|
504 Participants
|
|
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)
All ACS (Through 90 days)
|
472 Participants
|
588 Participants
|
SECONDARY outcome
Timeframe: Randomization to 30 days; randomization to 90 daysPopulation: Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.
The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods.
Outcome measures
| Measure |
Prasugrel
n=6813 Participants
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
n=6795 Participants
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
All ACS (Through 30 days)
|
389 Participants
|
502 Participants
|
|
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
All ACS (Through 90 days)
|
462 Participants
|
573 Participants
|
SECONDARY outcome
Timeframe: Randomization up to 15 monthsPopulation: Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.
The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population.
Outcome measures
| Measure |
Prasugrel
n=6813 Participants
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
n=6795 Participants
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events
|
797 Participants
|
938 Participants
|
SECONDARY outcome
Timeframe: Randomization up to 15 monthsPopulation: Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.
The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population.
Outcome measures
| Measure |
Prasugrel
n=6813 Participants
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
n=6795 Participants
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
|
692 Participants
|
822 Participants
|
Adverse Events
Prasugrel
Serious events: 1731 serious events
Other events: 5217 other events
Deaths: 0 deaths
Clopidogrel
Serious events: 1675 serious events
Other events: 5187 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prasugrel
n=6741 participants at risk
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
n=6716 participants at risk
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.58%
39/6741 • Number of events 39
|
0.51%
34/6716 • Number of events 35
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.12%
8/6741 • Number of events 8
|
0.06%
4/6716 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6741
|
0.07%
5/6716 • Number of events 5
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.22%
15/6741 • Number of events 15
|
0.22%
15/6716 • Number of events 15
|
|
Cardiac disorders
Acute coronary syndrome
|
0.03%
2/6741 • Number of events 2
|
0.04%
3/6716 • Number of events 3
|
|
Cardiac disorders
Acute left ventricular failure
|
0.01%
1/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Acute myocardial infarction
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
1.3%
85/6741 • Number of events 87
|
1.3%
86/6716 • Number of events 95
|
|
Cardiac disorders
Angina unstable
|
0.37%
25/6741 • Number of events 27
|
0.55%
37/6716 • Number of events 39
|
|
Cardiac disorders
Aortic valve incompetence
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Aortic valve stenosis
|
0.03%
2/6741 • Number of events 2
|
0.04%
3/6716 • Number of events 3
|
|
Cardiac disorders
Arrhythmia
|
0.01%
1/6741 • Number of events 1
|
0.04%
3/6716 • Number of events 4
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Arteriospasm coronary
|
0.03%
2/6741 • Number of events 2
|
0.06%
4/6716 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
0.74%
50/6741 • Number of events 51
|
0.77%
52/6716 • Number of events 56
|
|
Cardiac disorders
Atrial flutter
|
0.18%
12/6741 • Number of events 12
|
0.06%
4/6716 • Number of events 4
|
|
Cardiac disorders
Atrial tachycardia
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Atrial thrombosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Atrioventricular block
|
0.01%
1/6741 • Number of events 1
|
0.06%
4/6716 • Number of events 4
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.04%
3/6741 • Number of events 3
|
0.07%
5/6716 • Number of events 5
|
|
Cardiac disorders
Atrioventricular block third degree
|
0.16%
11/6741 • Number of events 11
|
0.16%
11/6716 • Number of events 11
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.21%
14/6741 • Number of events 14
|
0.16%
11/6716 • Number of events 11
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.15%
10/6741 • Number of events 10
|
0.15%
10/6716 • Number of events 12
|
|
Cardiac disorders
Cardiac asthma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Cardiac failure
|
0.33%
22/6741 • Number of events 24
|
0.61%
41/6716 • Number of events 42
|
|
Cardiac disorders
Cardiac failure acute
|
0.04%
3/6741 • Number of events 3
|
0.04%
3/6716 • Number of events 4
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.68%
46/6741 • Number of events 48
|
0.70%
47/6716 • Number of events 48
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Cardiac pseudoaneurysm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Cardiac tamponade
|
0.07%
5/6741 • Number of events 5
|
0.06%
4/6716 • Number of events 4
|
|
Cardiac disorders
Cardiac valve disease
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Cardiogenic shock
|
0.19%
13/6741 • Number of events 14
|
0.12%
8/6716 • Number of events 8
|
|
Cardiac disorders
Cardiomyopathy
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Cardiovascular disorder
|
0.06%
4/6741 • Number of events 4
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Coronary artery aneurysm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Coronary artery disease
|
0.21%
14/6741 • Number of events 14
|
0.25%
17/6716 • Number of events 17
|
|
Cardiac disorders
Coronary artery dissection
|
0.07%
5/6741 • Number of events 5
|
0.16%
11/6716 • Number of events 11
|
|
Cardiac disorders
Coronary artery occlusion
|
0.12%
8/6741 • Number of events 8
|
0.10%
7/6716 • Number of events 7
|
|
Cardiac disorders
Coronary artery perforation
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Coronary artery restenosis
|
1.6%
107/6741 • Number of events 118
|
1.7%
111/6716 • Number of events 118
|
|
Cardiac disorders
Coronary artery stenosis
|
0.77%
52/6741 • Number of events 54
|
0.95%
64/6716 • Number of events 65
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 4
|
|
Cardiac disorders
Dressler's syndrome
|
0.06%
4/6741 • Number of events 4
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Electromechanical dissociation
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
In-stent arterial restenosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Interventricular septum rupture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Intracardiac thrombus
|
0.13%
9/6741 • Number of events 9
|
0.06%
4/6716 • Number of events 4
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.09%
6/6741 • Number of events 6
|
0.04%
3/6716 • Number of events 3
|
|
Cardiac disorders
Left ventricular failure
|
0.01%
1/6741 • Number of events 2
|
0.06%
4/6716 • Number of events 4
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.04%
3/6741 • Number of events 3
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Mitral valve disease
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Mitral valve incompetence
|
0.09%
6/6741 • Number of events 6
|
0.04%
3/6716 • Number of events 3
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Myocardial ischaemia
|
0.18%
12/6741 • Number of events 13
|
0.25%
17/6716 • Number of events 17
|
|
Cardiac disorders
Myocardial rupture
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Nodal arrhythmia
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Cardiac disorders
Palpitations
|
0.04%
3/6741 • Number of events 3
|
0.00%
0/6716
|
|
Cardiac disorders
Papillary muscle disorder
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Papillary muscle rupture
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.12%
8/6741 • Number of events 11
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.07%
5/6741 • Number of events 5
|
0.10%
7/6716 • Number of events 8
|
|
Cardiac disorders
Pericarditis
|
0.04%
3/6741 • Number of events 4
|
0.12%
8/6716 • Number of events 9
|
|
Cardiac disorders
Pleuropericarditis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 2
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Sick sinus syndrome
|
0.01%
1/6741 • Number of events 1
|
0.07%
5/6716 • Number of events 5
|
|
Cardiac disorders
Sinoatrial block
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Sinus arrest
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6741
|
0.09%
6/6716 • Number of events 6
|
|
Cardiac disorders
Sinus tachycardia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.12%
8/6741 • Number of events 10
|
0.07%
5/6716 • Number of events 6
|
|
Cardiac disorders
Tachyarrhythmia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Tachycardia
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Torsade de pointes
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Cardiac disorders
Ventricular dysfunction
|
0.01%
1/6741 • Number of events 1
|
0.06%
4/6716 • Number of events 4
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.09%
6/6741 • Number of events 6
|
0.04%
3/6716 • Number of events 3
|
|
Cardiac disorders
Ventricular fibrillation
|
0.27%
18/6741 • Number of events 19
|
0.37%
25/6716 • Number of events 25
|
|
Cardiac disorders
Ventricular flutter
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Ventricular septal defect acquired
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Cardiac disorders
Ventricular tachycardia
|
0.36%
24/6741 • Number of events 27
|
0.37%
25/6716 • Number of events 30
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Congenital, familial and genetic disorders
Laryngocele
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Ear and labyrinth disorders
Auricular perichondritis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Ear and labyrinth disorders
Vertigo
|
0.04%
3/6741 • Number of events 3
|
0.04%
3/6716 • Number of events 3
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Eye disorders
Cataract
|
0.06%
4/6741 • Number of events 4
|
0.04%
3/6716 • Number of events 3
|
|
Eye disorders
Conjunctival haemorrhage
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Eye disorders
Eye haemorrhage
|
0.06%
4/6741 • Number of events 4
|
0.00%
0/6716
|
|
Eye disorders
Eye inflammation
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Eye disorders
Glaucoma
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Eye disorders
Hyphaema
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Eye disorders
Macular hole
|
0.01%
1/6741 • Number of events 2
|
0.00%
0/6716
|
|
Eye disorders
Maculopathy
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Eye disorders
Vitreous haemorrhage
|
0.03%
2/6741 • Number of events 3
|
0.06%
4/6716 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal haematoma
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
7/6741 • Number of events 8
|
0.15%
10/6716 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.06%
4/6741 • Number of events 5
|
0.10%
7/6716 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 3
|
|
Gastrointestinal disorders
Colitis
|
0.04%
3/6741 • Number of events 3
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Colonic polyp
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6741
|
0.07%
5/6716 • Number of events 5
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.01%
1/6741 • Number of events 2
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Diarrhoea
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.04%
3/6741 • Number of events 3
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.01%
1/6741 • Number of events 1
|
0.06%
4/6716 • Number of events 4
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.04%
3/6741 • Number of events 3
|
0.04%
3/6716 • Number of events 3
|
|
Gastrointestinal disorders
Duodenitis
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Duodenitis haemorrhagic
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.01%
1/6741 • Number of events 1
|
0.07%
5/6716 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.04%
3/6741 • Number of events 3
|
0.12%
8/6716 • Number of events 8
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.12%
8/6741 • Number of events 8
|
0.09%
6/6716 • Number of events 6
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.07%
5/6741 • Number of events 5
|
0.07%
5/6716 • Number of events 5
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
7/6741 • Number of events 7
|
0.10%
7/6716 • Number of events 8
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.10%
7/6741 • Number of events 7
|
0.04%
3/6716 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
91/6741 • Number of events 95
|
0.82%
55/6716 • Number of events 61
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
6/6741 • Number of events 6
|
0.16%
11/6716 • Number of events 11
|
|
Gastrointestinal disorders
Gastrooesophagitis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Haematemesis
|
0.04%
3/6741 • Number of events 3
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Haematochezia
|
0.06%
4/6741 • Number of events 4
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.09%
6/6741 • Number of events 6
|
0.04%
3/6716 • Number of events 3
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.04%
3/6741 • Number of events 3
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
2/6741 • Number of events 2
|
0.07%
5/6716 • Number of events 5
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.06%
4/6741 • Number of events 4
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.03%
2/6741 • Number of events 3
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.10%
7/6741 • Number of events 8
|
0.15%
10/6716 • Number of events 11
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.04%
3/6741 • Number of events 3
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Melaena
|
0.09%
6/6741 • Number of events 6
|
0.09%
6/6716 • Number of events 6
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.04%
3/6741 • Number of events 3
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Oesophagitis
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.09%
6/6741 • Number of events 6
|
0.04%
3/6716 • Number of events 4
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
5/6741 • Number of events 5
|
0.07%
5/6716 • Number of events 5
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.01%
1/6741 • Number of events 1
|
0.04%
3/6716 • Number of events 3
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.03%
2/6741 • Number of events 2
|
0.04%
3/6716 • Number of events 3
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Peritonitis
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.16%
11/6741 • Number of events 11
|
0.07%
5/6716 • Number of events 5
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.03%
2/6741 • Number of events 2
|
0.04%
3/6716 • Number of events 3
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.07%
5/6741 • Number of events 5
|
0.06%
4/6716 • Number of events 4
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.22%
15/6741 • Number of events 16
|
0.13%
9/6716 • Number of events 9
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
4/6741 • Number of events 4
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Subileus
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Toothache
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.22%
15/6741 • Number of events 16
|
0.12%
8/6716 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
General disorders
Abasia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Adverse drug reaction
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Asthenia
|
0.06%
4/6741 • Number of events 4
|
0.04%
3/6716 • Number of events 3
|
|
General disorders
Catheter site haemorrhage
|
0.01%
1/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.10%
7/6741 • Number of events 7
|
0.10%
7/6716 • Number of events 8
|
|
General disorders
Chest pain
|
1.3%
91/6741 • Number of events 98
|
1.1%
73/6716 • Number of events 78
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Gait disturbance
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
General physical health deterioration
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Generalised oedema
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Heparin-induced thrombocytopenia
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Hernia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
General disorders
Inflammation
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
General disorders
Ischaemic ulcer
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
General disorders
Malaise
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Multi-organ disorder
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Necrosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
2.0%
138/6741 • Number of events 155
|
2.5%
167/6716 • Number of events 179
|
|
General disorders
Oedema peripheral
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Puncture site haemorrhage
|
0.45%
30/6741 • Number of events 30
|
0.27%
18/6716 • Number of events 18
|
|
General disorders
Pyrexia
|
0.18%
12/6741 • Number of events 13
|
0.09%
6/6716 • Number of events 6
|
|
General disorders
Submandibular mass
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Sudden cardiac death
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
General disorders
Ulcer
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
General disorders
Vessel puncture site haematoma
|
0.31%
21/6741 • Number of events 21
|
0.21%
14/6716 • Number of events 14
|
|
General disorders
Vessel puncture site haemorrhage
|
0.19%
13/6741 • Number of events 13
|
0.15%
10/6716 • Number of events 10
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Hepatobiliary disorders
Biliary cirrhosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Hepatobiliary disorders
Biliary colic
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Cholaemia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Cholecystitis
|
0.07%
5/6741 • Number of events 5
|
0.07%
5/6716 • Number of events 5
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.06%
4/6741 • Number of events 4
|
0.10%
7/6716 • Number of events 7
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.15%
10/6741 • Number of events 10
|
0.19%
13/6716 • Number of events 13
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Hepatic failure
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 2
|
|
Immune system disorders
Anaphylactic reaction
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Immune system disorders
Anaphylactic shock
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Immune system disorders
Drug hypersensitivity
|
0.01%
1/6741 • Number of events 1
|
0.04%
3/6716 • Number of events 3
|
|
Immune system disorders
Hypersensitivity
|
0.04%
3/6741 • Number of events 3
|
0.03%
2/6716 • Number of events 3
|
|
Immune system disorders
Polyarteritis nodosa
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Abscess
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Abscess limb
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Anal abscess
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Appendicitis
|
0.07%
5/6741 • Number of events 5
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Bronchitis
|
0.04%
3/6741 • Number of events 3
|
0.07%
5/6716 • Number of events 5
|
|
Infections and infestations
Bronchitis acute
|
0.13%
9/6741 • Number of events 9
|
0.04%
3/6716 • Number of events 3
|
|
Infections and infestations
Bronchitis chronic
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Infections and infestations
Bronchopneumonia
|
0.07%
5/6741 • Number of events 5
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Catheter site infection
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Cellulitis
|
0.16%
11/6741 • Number of events 12
|
0.09%
6/6716 • Number of events 6
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.12%
8/6741 • Number of events 10
|
0.07%
5/6716 • Number of events 5
|
|
Infections and infestations
Endocarditis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Endocarditis bacterial
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Febrile infection
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Gangrene
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Gas gangrene
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Gastritis viral
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Gastroenteritis
|
0.15%
10/6741 • Number of events 10
|
0.09%
6/6716 • Number of events 6
|
|
Infections and infestations
Gastroenteritis viral
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Giardiasis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Groin abscess
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Helicobacter gastritis
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Infections and infestations
Hepatitis c
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Influenza
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.07%
5/6741 • Number of events 5
|
0.09%
6/6716 • Number of events 6
|
|
Infections and infestations
Localised infection
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Infections and infestations
Lung infection
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Infections and infestations
Meningitis viral
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Neuroborreliosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Oral infection
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Osteomyelitis
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Parotitis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Penile infection
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Perianal abscess
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Infections and infestations
Peritonitis bacterial
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Pneumonia
|
0.64%
43/6741 • Number of events 45
|
0.77%
52/6716 • Number of events 54
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Pneumonia streptococcal
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Pneumonia viral
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Postoperative wound infection
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Pyothorax
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Rectal abscess
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Respiratory tract infection
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Salmonellosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Salpingitis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.12%
8/6741 • Number of events 8
|
0.13%
9/6716 • Number of events 9
|
|
Infections and infestations
Sepsis syndrome
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Septic shock
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Skin infection
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Infections and infestations
Staphylococcal sepsis
|
0.06%
4/6741 • Number of events 4
|
0.00%
0/6716
|
|
Infections and infestations
Streptococcal sepsis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Infections and infestations
Tracheobronchitis
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.01%
1/6741 • Number of events 1
|
0.09%
6/6716 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
0.22%
15/6741 • Number of events 17
|
0.28%
19/6716 • Number of events 19
|
|
Infections and infestations
Urosepsis
|
0.09%
6/6741 • Number of events 6
|
0.04%
3/6716 • Number of events 3
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.06%
4/6741 • Number of events 4
|
0.04%
3/6716 • Number of events 3
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Infections and infestations
Wound infection staphylococcal
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bronchial injury
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.09%
6/6741 • Number of events 7
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Coronary artery reocclusion
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Injury, poisoning and procedural complications
Eyeball rupture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Face injury
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Failure of implant
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.16%
11/6741 • Number of events 12
|
0.18%
12/6716 • Number of events 12
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Hepatic trauma
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.06%
4/6741 • Number of events 4
|
0.09%
6/6716 • Number of events 6
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.04%
3/6741 • Number of events 3
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Injury
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Intervertebral disc injury
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.25%
17/6741 • Number of events 18
|
0.10%
7/6716 • Number of events 7
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Polytraumatism
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.30%
20/6741 • Number of events 20
|
0.12%
8/6716 • Number of events 8
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.06%
4/6741 • Number of events 4
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
2/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.06%
4/6741 • Number of events 4
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.03%
2/6741 • Number of events 2
|
0.06%
4/6716 • Number of events 4
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.03%
2/6741 • Number of events 2
|
0.04%
3/6716 • Number of events 3
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.07%
5/6741 • Number of events 5
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.01%
1/6741 • Number of events 1
|
0.09%
6/6716 • Number of events 6
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.10%
7/6741 • Number of events 7
|
0.15%
10/6716 • Number of events 10
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 2
|
|
Investigations
Angiogram
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Investigations
Blood pressure increased
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Investigations
Cardiac enzymes increased
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Investigations
Ejection fraction decreased
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Investigations
Electrocardiogram abnormal
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Investigations
Electrocardiogram change
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Investigations
Electrocardiogram st segment elevation
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Investigations
Haemoglobin abnormal
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Investigations
Haemoglobin decreased
|
0.15%
10/6741 • Number of events 10
|
0.09%
6/6716 • Number of events 6
|
|
Investigations
Hepatic enzyme increased
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Investigations
International normalised ratio increased
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Investigations
Liver function test abnormal
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Investigations
Occult blood positive
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Investigations
Prostate examination abnormal
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Investigations
Renal function test abnormal
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Investigations
Transaminases increased
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Investigations
Troponin increased
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Investigations
Weight decreased
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
14/6741 • Number of events 14
|
0.13%
9/6716 • Number of events 9
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.06%
4/6741 • Number of events 4
|
0.10%
7/6716 • Number of events 7
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.06%
4/6741 • Number of events 4
|
0.04%
3/6716 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.09%
6/6741 • Number of events 6
|
0.13%
9/6716 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.01%
1/6741 • Number of events 1
|
0.06%
4/6716 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.06%
4/6741 • Number of events 4
|
0.07%
5/6716 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.03%
2/6741 • Number of events 2
|
0.04%
3/6716 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.04%
3/6741 • Number of events 3
|
0.04%
3/6716 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
5/6741 • Number of events 5
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.03%
2/6741 • Number of events 4
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.06%
4/6741 • Number of events 4
|
0.09%
6/6716 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.15%
10/6741 • Number of events 10
|
0.22%
15/6716 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.01%
1/6741 • Number of events 1
|
0.10%
7/6716 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.03%
2/6741 • Number of events 2
|
0.12%
8/6716 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
8/6741 • Number of events 8
|
0.13%
9/6716 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.07%
5/6741 • Number of events 5
|
0.07%
5/6716 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.04%
3/6741 • Number of events 3
|
0.04%
3/6716 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.03%
2/6741 • Number of events 2
|
0.06%
4/6716 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage iii
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.06%
4/6741 • Number of events 4
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell carcinoma of the kidney
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.15%
10/6741 • Number of events 10
|
0.03%
2/6716 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.09%
6/6741 • Number of events 6
|
0.10%
7/6716 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.06%
4/6741 • Number of events 4
|
0.03%
2/6716 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.01%
1/6741 • Number of events 1
|
0.04%
3/6716 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral t-cell lymphoma unspecified
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.09%
6/6741 • Number of events 6
|
0.10%
7/6716 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.01%
1/6741 • Number of events 1
|
0.04%
3/6716 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Ageusia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 2
|
|
Nervous system disorders
Carotid artery occlusion
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 2
|
|
Nervous system disorders
Carotid artery stenosis
|
0.27%
18/6741 • Number of events 19
|
0.15%
10/6716 • Number of events 12
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
5/6741 • Number of events 5
|
0.03%
2/6716 • Number of events 2
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Nervous system disorders
Coma
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.03%
2/6741 • Number of events 2
|
0.04%
3/6716 • Number of events 3
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Dementia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Diabetic neuropathy
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Dizziness
|
0.07%
5/6741 • Number of events 5
|
0.12%
8/6716 • Number of events 8
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Global amnesia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.07%
5/6741 • Number of events 5
|
0.06%
4/6716 • Number of events 4
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.04%
3/6741 • Number of events 3
|
0.06%
4/6716 • Number of events 4
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Nervous system disorders
Hemiparesis
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Hypotonia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Nervous system disorders
Iiird nerve paralysis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Lethargy
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Nervous system disorders
Migraine
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 3
|
|
Nervous system disorders
Monoparesis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Neurological symptom
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Neuropathy peripheral
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Paraesthesia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Periodic limb movement disorder
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Presyncope
|
0.16%
11/6741 • Number of events 11
|
0.12%
8/6716 • Number of events 8
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Senile dementia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Syncope
|
0.52%
35/6741 • Number of events 35
|
0.43%
29/6716 • Number of events 31
|
|
Nervous system disorders
Syncope vasovagal
|
0.06%
4/6741 • Number of events 4
|
0.06%
4/6716 • Number of events 4
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.24%
16/6741 • Number of events 17
|
0.33%
22/6716 • Number of events 23
|
|
Nervous system disorders
Tremor
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Psychiatric disorders
Alcoholism
|
0.01%
1/6741 • Number of events 1
|
0.04%
3/6716 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
0.07%
5/6741 • Number of events 5
|
0.10%
7/6716 • Number of events 7
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Psychiatric disorders
Bipolar disorder
|
0.04%
3/6741 • Number of events 3
|
0.00%
0/6716
|
|
Psychiatric disorders
Confusional state
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Psychiatric disorders
Delirium
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.07%
5/6741 • Number of events 5
|
0.07%
5/6716 • Number of events 5
|
|
Psychiatric disorders
Disorientation
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Psychiatric disorders
Drug dependence
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Psychiatric disorders
Fear
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Psychiatric disorders
Major depression
|
0.04%
3/6741 • Number of events 3
|
0.00%
0/6716
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Psychiatric disorders
Neurosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Renal and urinary disorders
Azotaemia
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Renal and urinary disorders
Calculus urinary
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Renal and urinary disorders
Crush syndrome
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Renal and urinary disorders
Haematuria
|
0.40%
27/6741 • Number of events 31
|
0.18%
12/6716 • Number of events 14
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Renal and urinary disorders
Hydronephrosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
7/6741 • Number of events 7
|
0.03%
2/6716 • Number of events 2
|
|
Renal and urinary disorders
Nephropathy
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Renal and urinary disorders
Renal artery occlusion
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Renal and urinary disorders
Renal colic
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Renal and urinary disorders
Renal failure
|
0.22%
15/6741 • Number of events 15
|
0.25%
17/6716 • Number of events 17
|
|
Renal and urinary disorders
Renal failure acute
|
0.33%
22/6741 • Number of events 22
|
0.18%
12/6716 • Number of events 12
|
|
Renal and urinary disorders
Renal failure chronic
|
0.04%
3/6741 • Number of events 3
|
0.06%
4/6716 • Number of events 4
|
|
Renal and urinary disorders
Renal impairment
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.01%
1/6741 • Number of events 2
|
0.00%
0/6716
|
|
Renal and urinary disorders
Urinary retention
|
0.04%
3/6741 • Number of events 3
|
0.04%
3/6716 • Number of events 3
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.07%
5/6741 • Number of events 5
|
0.07%
5/6716 • Number of events 5
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Reproductive system and breast disorders
Cystocele
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymitis
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.04%
3/6741 • Number of events 4
|
0.12%
8/6716 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
7/6741 • Number of events 7
|
0.03%
2/6716 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.25%
17/6741 • Number of events 17
|
0.19%
13/6716 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.16%
11/6741 • Number of events 11
|
0.31%
21/6716 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.01%
1/6741 • Number of events 1
|
0.04%
3/6716 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.43%
29/6741 • Number of events 31
|
0.33%
22/6716 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.09%
6/6741 • Number of events 8
|
0.04%
3/6716 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.09%
6/6741 • Number of events 6
|
0.15%
10/6716 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.03%
2/6741 • Number of events 2
|
0.06%
4/6716 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
9/6741 • Number of events 9
|
0.06%
4/6716 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.46%
31/6741 • Number of events 38
|
0.40%
27/6716 • Number of events 29
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6741
|
0.06%
4/6716 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.22%
15/6741 • Number of events 15
|
0.09%
6/6716 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.04%
3/6741 • Number of events 3
|
0.03%
2/6716 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.04%
3/6741 • Number of events 3
|
0.03%
2/6716 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Stevens-johnson syndrome
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.04%
3/6741 • Number of events 3
|
0.01%
1/6716 • Number of events 1
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Surgical and medical procedures
Cataract operation
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Surgical and medical procedures
Dental operation
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Surgical and medical procedures
Eye operation
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Surgical and medical procedures
Finger amputation
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Surgical and medical procedures
Hernia repair
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Surgical and medical procedures
Incisional drainage
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.03%
2/6741 • Number of events 2
|
0.03%
2/6716 • Number of events 2
|
|
Surgical and medical procedures
Open reduction of fracture
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Surgical and medical procedures
Thrombectomy
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Surgical and medical procedures
Tumour excision
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/6741
|
0.03%
2/6716 • Number of events 2
|
|
Vascular disorders
Aneurysm
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Aneurysm ruptured
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Angiodysplasia
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Aortic aneurysm
|
0.06%
4/6741 • Number of events 4
|
0.03%
2/6716 • Number of events 2
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Aortic dissection
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Aortic rupture
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Arterial occlusive disease
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Arterial restenosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Arterial stenosis limb
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Arterial thrombosis limb
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Arteriosclerosis
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 3
|
|
Vascular disorders
Artery dissection
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Cardiovascular insufficiency
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Circulatory collapse
|
0.03%
2/6741 • Number of events 2
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.19%
13/6741 • Number of events 13
|
0.15%
10/6716 • Number of events 10
|
|
Vascular disorders
Extremity necrosis
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Femoral arterial stenosis
|
0.03%
2/6741 • Number of events 3
|
0.06%
4/6716 • Number of events 5
|
|
Vascular disorders
Femoral artery aneurysm
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Femoral artery dissection
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Femoral artery occlusion
|
0.06%
4/6741 • Number of events 4
|
0.04%
3/6716 • Number of events 3
|
|
Vascular disorders
Haematoma
|
0.24%
16/6741 • Number of events 16
|
0.25%
17/6716 • Number of events 17
|
|
Vascular disorders
Haemodynamic instability
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Haemorrhage
|
0.12%
8/6741 • Number of events 8
|
0.07%
5/6716 • Number of events 5
|
|
Vascular disorders
Hypertension
|
0.25%
17/6741 • Number of events 17
|
0.24%
16/6716 • Number of events 16
|
|
Vascular disorders
Hypertensive crisis
|
0.19%
13/6741 • Number of events 13
|
0.22%
15/6716 • Number of events 15
|
|
Vascular disorders
Hypertensive emergency
|
0.01%
1/6741 • Number of events 1
|
0.03%
2/6716 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.22%
15/6741 • Number of events 15
|
0.06%
4/6716 • Number of events 4
|
|
Vascular disorders
Hypovolaemic shock
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Iliac artery occlusion
|
0.04%
3/6741 • Number of events 3
|
0.07%
5/6716 • Number of events 5
|
|
Vascular disorders
Iliac artery stenosis
|
0.03%
2/6741 • Number of events 2
|
0.09%
6/6716 • Number of events 7
|
|
Vascular disorders
Intermittent claudication
|
0.07%
5/6741 • Number of events 5
|
0.04%
3/6716 • Number of events 4
|
|
Vascular disorders
Ischaemia
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Jugular vein thrombosis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.07%
5/6741 • Number of events 5
|
0.04%
3/6716 • Number of events 3
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Peripheral artery dissection
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/6741
|
0.04%
3/6716 • Number of events 4
|
|
Vascular disorders
Peripheral vascular disorder
|
0.12%
8/6741 • Number of events 8
|
0.16%
11/6716 • Number of events 11
|
|
Vascular disorders
Reperfusion injury
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Shock
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Shock haemorrhagic
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
0.01%
1/6741 • Number of events 1
|
0.00%
0/6716
|
|
Vascular disorders
Thrombosis
|
0.03%
2/6741 • Number of events 2
|
0.00%
0/6716
|
|
Vascular disorders
Varicose vein
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.37%
25/6741 • Number of events 26
|
0.39%
26/6716 • Number of events 26
|
|
Vascular disorders
Vascular stenosis
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Vasospasm
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/6741
|
0.01%
1/6716 • Number of events 1
|
|
Vascular disorders
Wound haemorrhage
|
0.01%
1/6741 • Number of events 1
|
0.01%
1/6716 • Number of events 1
|
Other adverse events
| Measure |
Prasugrel
n=6741 participants at risk
Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
|
Clopidogrel
n=6716 participants at risk
Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
4.5%
302/6741 • Number of events 340
|
5.0%
334/6716 • Number of events 382
|
|
Gastrointestinal disorders
Nausea
|
4.6%
308/6741 • Number of events 327
|
4.3%
290/6716 • Number of events 306
|
|
General disorders
Chest pain
|
10.2%
690/6741 • Number of events 818
|
9.6%
643/6716 • Number of events 771
|
|
General disorders
Fatigue
|
3.7%
249/6741 • Number of events 261
|
4.8%
324/6716 • Number of events 339
|
|
Injury, poisoning and procedural complications
Contusion
|
6.9%
464/6741 • Number of events 529
|
3.9%
262/6716 • Number of events 302
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.8%
325/6741 • Number of events 325
|
4.8%
325/6716 • Number of events 325
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
336/6741 • Number of events 358
|
4.5%
304/6716 • Number of events 326
|
|
Nervous system disorders
Dizziness
|
4.0%
271/6741 • Number of events 298
|
4.5%
300/6716 • Number of events 325
|
|
Nervous system disorders
Headache
|
5.5%
372/6741 • Number of events 402
|
5.3%
353/6716 • Number of events 388
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
264/6741 • Number of events 277
|
4.1%
274/6716 • Number of events 281
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
319/6741 • Number of events 339
|
4.2%
284/6716 • Number of events 295
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
398/6741 • Number of events 480
|
3.0%
204/6716 • Number of events 251
|
|
Surgical and medical procedures
Coronary revascularisation
|
4.6%
313/6741 • Number of events 346
|
5.8%
389/6716 • Number of events 427
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
9.9%
668/6741 • Number of events 748
|
10.3%
690/6716 • Number of events 779
|
|
Vascular disorders
Haematoma
|
6.3%
426/6741 • Number of events 474
|
5.3%
357/6716 • Number of events 378
|
|
Vascular disorders
Hypertension
|
7.3%
490/6741 • Number of events 495
|
6.8%
460/6716 • Number of events 468
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60