Trial Outcomes & Findings for A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction (NCT NCT01015287)
NCT ID: NCT01015287
Last Updated: 2014-02-28
Results Overview
The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4033 participants
Primary outcome timeframe
First loading dose (LD) through 7 days after first LD
Results posted on
2014-02-28
Participant Flow
Participant milestones
| Measure |
Non Pre-treatment
A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Overall Study
STARTED
|
1996
|
2037
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
1996
|
2037
|
|
Overall Study
COMPLETED
|
1924
|
1958
|
|
Overall Study
NOT COMPLETED
|
72
|
79
|
Reasons for withdrawal
| Measure |
Non Pre-treatment
A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Overall Study
Death
|
21
|
16
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
3
|
7
|
|
Overall Study
Physician Decision
|
19
|
21
|
|
Overall Study
Withdrawal by Subject
|
14
|
19
|
|
Overall Study
Entry Criteria not Met
|
11
|
14
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction
Baseline characteristics by cohort
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Total
n=4033 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.59 years
STANDARD_DEVIATION 11.239 • n=5 Participants
|
63.80 years
STANDARD_DEVIATION 11.270 • n=7 Participants
|
63.69 years
STANDARD_DEVIATION 11.254 • n=5 Participants
|
|
Sex: Female, Male
Female
|
558 Participants
n=5 Participants
|
552 Participants
n=7 Participants
|
1110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1438 Participants
n=5 Participants
|
1485 Participants
n=7 Participants
|
2923 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First loading dose (LD) through 7 days after first LDPopulation: All randomized participants who received at least 1 dose of study drug.
The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout
|
9.77 percentage of participants
|
9.97 percentage of participants
|
SECONDARY outcome
Timeframe: First loading dose (LD) through 7 days after first LDPopulation: All randomized participants who received at least 1 dose of study drug.
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
|
7.57 percentage of participants
|
8.64 percentage of participants
|
SECONDARY outcome
Timeframe: First LD through 30 days after first LDPopulation: All randomized participants who received at least 1 dose of study drug.
The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)
|
7.21 percentage of participants
|
7.07 percentage of participants
|
SECONDARY outcome
Timeframe: First LD through 30 days after first LDPopulation: All randomized participants who received at least 1 dose of study drug.
The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)
|
6.51 percentage of participants
|
6.63 percentage of participants
|
SECONDARY outcome
Timeframe: First LD through 30 days after first LDPopulation: All randomized participants who received at least 1 dose of study drug.
The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)
|
7.31 percentage of participants
|
7.71 percentage of participants
|
SECONDARY outcome
Timeframe: First LD through 30 days after first LDPopulation: All randomized participants who received at least 1 dose of study drug.
The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)
|
1.10 percentage of participants
|
0.69 percentage of participants
|
SECONDARY outcome
Timeframe: First LD through 30 days after first LDPopulation: All randomized participants who received at least 1 dose of study drug.
ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)
|
0.25 percentage of participants
|
0.10 percentage of participants
|
SECONDARY outcome
Timeframe: First LD through 30 days after first LDPopulation: All randomized participants who received at least 1 dose of study drug.
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)
|
8.52 percentage of participants
|
9.47 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, before PCI (not greater than 48 hours after randomization)Population: All randomized participants who received at least 1 dose of study drug, had standardized troponin measured at baseline and before PCI (not greater than 48 hours after randomization).
Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.
Outcome measures
| Measure |
Non Pre-treatment
n=454 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=511 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)
|
-11.24 ratio of assayed troponin/ULN
Standard Error 8.93
|
2.82 ratio of assayed troponin/ULN
Standard Error 8.42
|
SECONDARY outcome
Timeframe: First loading dose (LD) through 7 days after first LDPopulation: All randomized participants who received at least 1 dose of study drug.
The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding
|
1.35 percentage of participants
|
2.55 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 30 daysPopulation: All randomized participants who received at least 1 dose of study drug.
All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.
Outcome measures
| Measure |
Non Pre-treatment
n=1996 Participants
A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 Participants
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Summary of All-Cause Death
Congestive Heart Failure
|
1 participants
|
0 participants
|
|
Summary of All-Cause Death
Cardiogenic Shock
|
5 participants
|
5 participants
|
|
Summary of All-Cause Death
During or Immediately Following a CABG Procedure
|
5 participants
|
1 participants
|
|
Summary of All-Cause Death
During or Immediately Following a PCI Procedure
|
2 participants
|
1 participants
|
|
Summary of All-Cause Death
Myocardial Infarction
|
2 participants
|
1 participants
|
|
Summary of All-Cause Death
Dysrhythmia
|
0 participants
|
1 participants
|
|
Summary of All-Cause Death
Sudden Cardiac Death
|
4 participants
|
1 participants
|
|
Summary of All-Cause Death
Intracranial Hemorrhage
|
1 participants
|
1 participants
|
|
Summary of All-Cause Death
Stroke, non-hemorrhagic
|
0 participants
|
1 participants
|
|
Summary of All-Cause Death
Other Cardiovascular
|
2 participants
|
2 participants
|
|
Summary of All-Cause Death
Non-Cardiac Hemorrhage, Not Intracranial
|
0 participants
|
1 participants
|
|
Summary of All-Cause Death
Infection
|
1 participants
|
0 participants
|
|
Summary of All-Cause Death
Cancer
|
0 participants
|
1 participants
|
Adverse Events
Non Pre-treatment
Serious events: 167 serious events
Other events: 860 other events
Deaths: 0 deaths
Pre-treatment
Serious events: 206 serious events
Other events: 876 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non Pre-treatment
n=1996 participants at risk
A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 participants at risk
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperchromic anaemia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.15%
3/1996 • Number of events 3
|
0.29%
6/2037 • Number of events 6
|
|
Cardiac disorders
Angina pectoris
|
0.05%
1/1996 • Number of events 1
|
0.25%
5/2037 • Number of events 6
|
|
Cardiac disorders
Angina unstable
|
0.10%
2/1996 • Number of events 2
|
0.29%
6/2037 • Number of events 6
|
|
Cardiac disorders
Aortic valve incompetence
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Arteriospasm coronary
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
4/1996 • Number of events 5
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Atrioventricular block
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Atrioventricular block complete
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Cardiac arrest
|
0.15%
3/1996 • Number of events 3
|
0.25%
5/2037 • Number of events 5
|
|
Cardiac disorders
Cardiac failure
|
0.20%
4/1996 • Number of events 4
|
0.15%
3/2037 • Number of events 4
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Cardiac disorders
Cardiac tamponade
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Cardiogenic shock
|
0.25%
5/1996 • Number of events 5
|
0.34%
7/2037 • Number of events 7
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Coronary artery dissection
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Coronary artery embolism
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.20%
4/1996 • Number of events 4
|
0.25%
5/2037 • Number of events 5
|
|
Cardiac disorders
Coronary no-reflow phenomenon
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Haemorrhage coronary artery
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Intracardiac thrombus
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Left ventricular failure
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Cardiac disorders
Myocardial infarction
|
0.50%
10/1996 • Number of events 10
|
0.74%
15/2037 • Number of events 15
|
|
Cardiac disorders
Myocardial ischaemia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Myocardial rupture
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Pericardial effusion
|
0.20%
4/1996 • Number of events 4
|
0.00%
0/2037
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/1996
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Pericarditis
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Pericarditis constrictive
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Pleuropericarditis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Postinfarction angina
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Sinus arrest
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.25%
5/1996 • Number of events 5
|
0.34%
7/2037 • Number of events 7
|
|
Cardiac disorders
Ventricular flutter
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
4/1996 • Number of events 4
|
0.20%
4/2037 • Number of events 4
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Abdominal pain
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.15%
3/1996 • Number of events 3
|
0.25%
5/2037 • Number of events 5
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.15%
3/2037 • Number of events 3
|
|
General disorders
Asthenia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Chest pain
|
0.40%
8/1996 • Number of events 8
|
0.44%
9/2037 • Number of events 9
|
|
General disorders
Device dislocation
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.15%
3/1996 • Number of events 3
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Puncture site haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Pyrexia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Spinal pain
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Sudden cardiac death
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Sudden death
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Thrombosis in device
|
0.20%
4/1996 • Number of events 5
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Vessel puncture site haematoma
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Hepatobiliary disorders
Hepatic necrosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Immune system disorders
Hypersensitivity
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Bronchitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Cystitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Infections and infestations
Groin abscess
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Labyrinthitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.05%
1/1996 • Number of events 1
|
0.20%
4/2037 • Number of events 4
|
|
Infections and infestations
Puncture site infection
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Sepsis
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Fall
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.05%
1/1996 • Number of events 1
|
0.20%
4/2037 • Number of events 4
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/1996
|
0.29%
6/2037 • Number of events 6
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.20%
4/1996 • Number of events 4
|
0.29%
6/2037 • Number of events 6
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.10%
2/1996 • Number of events 2
|
0.29%
6/2037 • Number of events 6
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Cardiac output decreased
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Ejection fraction decreased
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Haemoglobin decreased
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Troponin increased
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Investigations
Troponin t increased
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Nervous system disorders
Convulsion
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Nervous system disorders
Dizziness
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 3
|
|
Nervous system disorders
Transient ischaemic attack
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Psychiatric disorders
Disorientation
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Renal and urinary disorders
Haematuria
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1996
|
0.15%
3/2037 • Number of events 3
|
|
Renal and urinary disorders
Renal failure acute
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.15%
3/1996 • Number of events 4
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
5/1996 • Number of events 5
|
0.20%
4/2037 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.20%
4/1996 • Number of events 4
|
0.15%
3/2037 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acute generalised exanthematous pustulosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.25%
5/1996 • Number of events 5
|
0.29%
6/2037 • Number of events 6
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.50%
10/1996 • Number of events 10
|
0.79%
16/2037 • Number of events 17
|
|
Surgical and medical procedures
Thrombolysis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Aneurysm
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Embolism
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.15%
3/1996 • Number of events 3
|
0.29%
6/2037 • Number of events 6
|
|
Vascular disorders
Haemodynamic instability
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Haemorrhage
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 3
|
|
Vascular disorders
Hypertension
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Vascular disorders
Ischaemia
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Shock
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
Other adverse events
| Measure |
Non Pre-treatment
n=1996 participants at risk
A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
Pre-treatment
n=2037 participants at risk
A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
|
|---|---|---|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Blood and lymphatic system disorders
Anaemia
|
0.50%
10/1996 • Number of events 10
|
0.83%
17/2037 • Number of events 17
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.15%
3/1996 • Number of events 3
|
0.20%
4/2037 • Number of events 4
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.20%
4/1996 • Number of events 4
|
0.25%
5/2037 • Number of events 5
|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Cardiac disorders
Acute coronary syndrome
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Acute myocardial infarction
|
0.05%
1/1996 • Number of events 1
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Angina pectoris
|
0.90%
18/1996 • Number of events 19
|
0.69%
14/2037 • Number of events 15
|
|
Cardiac disorders
Angina unstable
|
0.30%
6/1996 • Number of events 6
|
0.20%
4/2037 • Number of events 4
|
|
Cardiac disorders
Aortic valve incompetence
|
0.25%
5/1996 • Number of events 5
|
0.25%
5/2037 • Number of events 5
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Aortic valve stenosis
|
0.15%
3/1996 • Number of events 3
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Arrhythmia
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
28/1996 • Number of events 28
|
1.8%
36/2037 • Number of events 38
|
|
Cardiac disorders
Atrial flutter
|
0.25%
5/1996 • Number of events 5
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Atrial tachycardia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Atrioventricular block
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Cardiac disorders
Atrioventricular block complete
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/1996
|
0.29%
6/2037 • Number of events 6
|
|
Cardiac disorders
Bradycardia
|
1.1%
21/1996 • Number of events 21
|
1.2%
25/2037 • Number of events 25
|
|
Cardiac disorders
Bundle branch block right
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Cardiac aneurysm
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
1.1%
21/1996 • Number of events 21
|
0.74%
15/2037 • Number of events 15
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Cardiomegaly
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.05%
1/1996 • Number of events 1
|
0.20%
4/2037 • Number of events 4
|
|
Cardiac disorders
Coronary artery dissection
|
0.15%
3/1996 • Number of events 3
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Coronary artery embolism
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Coronary artery occlusion
|
0.10%
2/1996 • Number of events 2
|
0.29%
6/2037 • Number of events 6
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Coronary artery stenosis
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.15%
3/1996 • Number of events 3
|
0.34%
7/2037 • Number of events 7
|
|
Cardiac disorders
Coronary no-reflow phenomenon
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Dressler's syndrome
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.10%
2/1996 • Number of events 2
|
0.29%
6/2037 • Number of events 6
|
|
Cardiac disorders
Left ventricular failure
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Mitral valve incompetence
|
0.85%
17/1996 • Number of events 17
|
0.93%
19/2037 • Number of events 19
|
|
Cardiac disorders
Myocardial haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
49/1996 • Number of events 50
|
2.0%
41/2037 • Number of events 41
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Myocarditis
|
0.15%
3/1996 • Number of events 3
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
0.35%
7/1996 • Number of events 7
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Pulmonary valve incompetence
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Sick sinus syndrome
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Cardiac disorders
Sinoatrial block
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Sinus arrest
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Sinus bradycardia
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Sinus tachycardia
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.15%
3/1996 • Number of events 3
|
0.15%
3/2037 • Number of events 3
|
|
Cardiac disorders
Tachyarrhythmia
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.15%
3/1996 • Number of events 3
|
0.34%
7/2037 • Number of events 7
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.50%
10/1996 • Number of events 10
|
0.29%
6/2037 • Number of events 6
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.20%
4/1996 • Number of events 4
|
0.25%
5/2037 • Number of events 5
|
|
Cardiac disorders
Ventricular failure
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
10/1996 • Number of events 12
|
0.79%
16/2037 • Number of events 16
|
|
Congenital, familial and genetic disorders
Gene mutation
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Congenital, familial and genetic disorders
Right aortic arch
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Congenital, familial and genetic disorders
Type v hyperlipidaemia
|
0.00%
0/1996
|
0.15%
3/2037 • Number of events 3
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
5/1996 • Number of events 5
|
0.54%
11/2037 • Number of events 11
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Endocrine disorders
Goitre
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Endocrine disorders
Hyperthyroidism
|
0.20%
4/1996 • Number of events 4
|
0.20%
4/2037 • Number of events 4
|
|
Endocrine disorders
Hypothyroidism
|
0.20%
4/1996 • Number of events 4
|
0.10%
2/2037 • Number of events 2
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Eye disorders
Eye oedema
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Eye disorders
Panophthalmitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Eye disorders
Refraction disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Eye disorders
Visual impairment
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Abdominal distension
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
10/1996 • Number of events 11
|
0.39%
8/2037 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.20%
4/1996 • Number of events 4
|
0.59%
12/2037 • Number of events 12
|
|
Gastrointestinal disorders
Anal fissure
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.55%
11/1996 • Number of events 11
|
0.39%
8/2037 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhoea
|
0.95%
19/1996 • Number of events 19
|
0.93%
19/2037 • Number of events 19
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Duodenitis
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.25%
5/1996 • Number of events 5
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Gastric disorder
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
3/1996 • Number of events 3
|
0.29%
6/2037 • Number of events 6
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.05%
1/1996 • Number of events 1
|
0.20%
4/2037 • Number of events 4
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.45%
9/1996 • Number of events 9
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Haematochezia
|
0.25%
5/1996 • Number of events 5
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Melaena
|
0.05%
1/1996 • Number of events 1
|
0.15%
3/2037 • Number of events 3
|
|
Gastrointestinal disorders
Mesenteric haematoma
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.1%
22/1996 • Number of events 22
|
1.2%
25/2037 • Number of events 25
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Oral disorder
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Oral pain
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Rectal polyp
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.15%
3/1996 • Number of events 3
|
0.10%
2/2037 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
10/1996 • Number of events 10
|
0.44%
9/2037 • Number of events 9
|
|
General disorders
Asthenia
|
0.85%
17/1996 • Number of events 17
|
0.74%
15/2037 • Number of events 15
|
|
General disorders
Catheter site discharge
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Catheter site erythema
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
General disorders
Catheter site haematoma
|
0.30%
6/1996 • Number of events 6
|
0.25%
5/2037 • Number of events 5
|
|
General disorders
Catheter site haemorrhage
|
0.25%
5/1996 • Number of events 5
|
0.34%
7/2037 • Number of events 8
|
|
General disorders
Catheter site inflammation
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Catheter site pain
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
General disorders
Catheter site phlebitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Chest discomfort
|
0.30%
6/1996 • Number of events 6
|
0.29%
6/2037 • Number of events 6
|
|
General disorders
Chest pain
|
2.8%
55/1996 • Number of events 56
|
2.3%
47/2037 • Number of events 50
|
|
General disorders
Chills
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Cyst
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Device dislocation
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Discomfort
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Drug intolerance
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
General disorders
Fatigue
|
0.15%
3/1996 • Number of events 3
|
0.44%
9/2037 • Number of events 9
|
|
General disorders
Feeling abnormal
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Feeling cold
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Gait disturbance
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Hyperthermia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Hypertrophy
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Inflammation
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
General disorders
Injection site haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Injection site induration
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Malaise
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
General disorders
Non-cardiac chest pain
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Oedema
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.45%
9/1996 • Number of events 9
|
0.69%
14/2037 • Number of events 15
|
|
General disorders
Pain
|
0.20%
4/1996 • Number of events 4
|
0.10%
2/2037 • Number of events 2
|
|
General disorders
Polyp
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Puncture site discharge
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
General disorders
Puncture site haemorrhage
|
0.10%
2/1996 • Number of events 2
|
0.34%
7/2037 • Number of events 7
|
|
General disorders
Puncture site pain
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
General disorders
Pyrexia
|
1.2%
24/1996 • Number of events 24
|
1.6%
33/2037 • Number of events 33
|
|
General disorders
Spinal pain
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 3
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
General disorders
Thrombosis in device
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
General disorders
Vessel puncture site haematoma
|
0.45%
9/1996 • Number of events 9
|
0.59%
12/2037 • Number of events 12
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/1996
|
0.20%
4/2037 • Number of events 6
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.15%
3/1996 • Number of events 3
|
0.15%
3/2037 • Number of events 3
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Immune system disorders
Allergy to chemicals
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Immune system disorders
Contrast media allergy
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Immune system disorders
Drug hypersensitivity
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Immune system disorders
Hypersensitivity
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Immune system disorders
Iodine allergy
|
0.20%
4/1996 • Number of events 4
|
0.10%
2/2037 • Number of events 2
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.15%
3/1996 • Number of events 3
|
0.15%
3/2037 • Number of events 3
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Candidiasis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.15%
3/1996 • Number of events 3
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Erysipelas
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Eye abscess
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Genital infection fungal
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Gingivitis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Groin infection
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Hepatitis a
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Hepatitis e
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Infected skin ulcer
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Infection
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Infections and infestations
Influenza
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Leprosy
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Lung infection
|
0.05%
1/1996 • Number of events 1
|
0.15%
3/2037 • Number of events 3
|
|
Infections and infestations
Lymphangitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Nasopharyngitis
|
0.15%
3/1996 • Number of events 3
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Oral fungal infection
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Pharyngitis
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.25%
5/1996 • Number of events 5
|
0.29%
6/2037 • Number of events 6
|
|
Infections and infestations
Post procedural infection
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Respiratory tract infection
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Infections and infestations
Septic shock
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1996
|
0.20%
4/2037 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
0.50%
10/1996 • Number of events 10
|
0.49%
10/2037 • Number of events 10
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/1996
|
0.18%
1/552 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Arteriovenous graft aneurysm
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 3
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Contusion
|
0.70%
14/1996 • Number of events 14
|
0.74%
15/2037 • Number of events 16
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dislocation of sternum
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Injury, poisoning and procedural complications
Face injury
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.20%
4/1996 • Number of events 4
|
0.44%
9/2037 • Number of events 9
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.25%
5/1996 • Number of events 5
|
0.34%
7/2037 • Number of events 7
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.20%
4/1996 • Number of events 4
|
0.25%
5/2037 • Number of events 5
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.15%
3/1996 • Number of events 3
|
0.10%
2/2037 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.15%
3/1996 • Number of events 3
|
0.15%
3/2037 • Number of events 3
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Amylase increased
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Antibiotic resistant staphylococcus test positive
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Aortic bruit
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Arteriogram coronary
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Blood bilirubin decreased
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.35%
7/1996 • Number of events 7
|
0.29%
6/2037 • Number of events 6
|
|
Investigations
Blood creatine phosphokinase mb increased
|
0.20%
4/1996 • Number of events 4
|
0.10%
2/2037 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.05%
1/1996 • Number of events 1
|
0.20%
4/2037 • Number of events 4
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Blood urine
|
0.05%
1/1996 • Number of events 2
|
0.00%
0/2037
|
|
Investigations
Blood urine present
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Body temperature increased
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Investigations
C-reactive protein increased
|
0.05%
1/1996 • Number of events 1
|
0.15%
3/2037 • Number of events 3
|
|
Investigations
Carbohydrate tolerance decreased
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Cardiac enzymes increased
|
0.80%
16/1996 • Number of events 16
|
0.93%
19/2037 • Number of events 19
|
|
Investigations
Cardiac murmur
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 3
|
|
Investigations
Central venous pressure increased
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Ejection fraction decreased
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Electrocardiogram qt prolonged
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Electrocardiogram st segment depression
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Electrocardiogram st segment elevation
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Electrophoresis protein abnormal
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Haemoglobin decreased
|
1.0%
20/1996 • Number of events 20
|
1.4%
28/2037 • Number of events 28
|
|
Investigations
Heart rate increased
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Hepatic enzyme increased
|
0.05%
1/1996 • Number of events 1
|
0.25%
5/2037 • Number of events 5
|
|
Investigations
Hepatitis c virus test positive
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Inflammatory marker increased
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Low density lipoprotein increased
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Peripheral pulse decreased
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Investigations
Platelet count decreased
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/1996
|
0.07%
1/1485 • Number of events 1
|
|
Investigations
Transaminases increased
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Investigations
Troponin i increased
|
0.20%
4/1996 • Number of events 4
|
0.20%
4/2037 • Number of events 4
|
|
Investigations
Troponin increased
|
0.15%
3/1996 • Number of events 3
|
0.20%
4/2037 • Number of events 4
|
|
Investigations
Urine output decreased
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
Weight increased
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.2%
24/1996 • Number of events 24
|
1.3%
27/2037 • Number of events 27
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.4%
27/1996 • Number of events 27
|
1.1%
22/2037 • Number of events 22
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.20%
4/1996 • Number of events 4
|
0.25%
5/2037 • Number of events 5
|
|
Metabolism and nutrition disorders
Gout
|
0.15%
3/1996 • Number of events 3
|
0.15%
3/2037 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.4%
87/1996 • Number of events 87
|
3.5%
72/2037 • Number of events 72
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.20%
4/1996 • Number of events 4
|
0.29%
6/2037 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.1%
42/1996 • Number of events 42
|
1.3%
26/2037 • Number of events 26
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.20%
4/1996 • Number of events 4
|
0.25%
5/2037 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypo hdl cholesterolaemia
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.90%
18/1996 • Number of events 18
|
0.69%
14/2037 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Metabolism and nutrition disorders
Lipid metabolism disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Metabolism and nutrition disorders
Obesity
|
0.25%
5/1996 • Number of events 5
|
0.10%
2/2037 • Number of events 2
|
|
Metabolism and nutrition disorders
Overweight
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.30%
6/1996 • Number of events 6
|
0.34%
7/2037 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.15%
3/1996 • Number of events 3
|
0.34%
7/2037 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.75%
15/1996 • Number of events 15
|
0.98%
20/2037 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.05%
1/1996 • Number of events 1
|
0.25%
5/2037 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.10%
2/1996 • Number of events 2
|
0.25%
5/2037 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1996
|
0.20%
4/2037 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1996
|
0.15%
3/2037 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.35%
7/1996 • Number of events 7
|
0.29%
6/2037 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.35%
7/1996 • Number of events 7
|
0.44%
9/2037 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.70%
14/1996 • Number of events 14
|
0.83%
17/2037 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Akinesia
|
0.05%
1/1996 • Number of events 2
|
0.00%
0/2037
|
|
Nervous system disorders
Burning sensation
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.15%
3/1996 • Number of events 3
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/1996
|
0.15%
3/2037 • Number of events 3
|
|
Nervous system disorders
Carotid artery stenosis
|
0.15%
3/1996 • Number of events 3
|
0.20%
4/2037 • Number of events 4
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.15%
3/1996 • Number of events 3
|
0.10%
2/2037 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.55%
11/1996 • Number of events 11
|
0.69%
14/2037 • Number of events 14
|
|
Nervous system disorders
Drop attacks
|
0.05%
1/1996 • Number of events 2
|
0.00%
0/2037
|
|
Nervous system disorders
Dysarthria
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.4%
48/1996 • Number of events 48
|
2.2%
44/2037 • Number of events 45
|
|
Nervous system disorders
Hypoaesthesia
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Hypotonia
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Nervous system disorders
Ischaemic stroke
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Nervous system disorders
Motor dysfunction
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Nervous system disorders
Presyncope
|
0.40%
8/1996 • Number of events 8
|
0.49%
10/2037 • Number of events 10
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.25%
5/1996 • Number of events 5
|
0.15%
3/2037 • Number of events 3
|
|
Nervous system disorders
Transient ischaemic attack
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Nervous system disorders
Tremor
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Psychiatric disorders
Agitation
|
0.05%
1/1996 • Number of events 1
|
0.15%
3/2037 • Number of events 3
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.50%
10/1996 • Number of events 10
|
0.64%
13/2037 • Number of events 13
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1996
|
0.29%
6/2037 • Number of events 6
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.20%
4/1996 • Number of events 4
|
0.15%
3/2037 • Number of events 3
|
|
Psychiatric disorders
Disorientation
|
0.10%
2/1996 • Number of events 2
|
0.15%
3/2037 • Number of events 4
|
|
Psychiatric disorders
Hallucination
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Psychiatric disorders
Histrionic personality disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.30%
6/1996 • Number of events 6
|
0.15%
3/2037 • Number of events 3
|
|
Psychiatric disorders
Libido disorder
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Psychiatric disorders
Mental disorder
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Psychiatric disorders
Panic disorder
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Psychiatric disorders
Sleep disorder
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Psychiatric disorders
Transient psychosis
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Renal and urinary disorders
Dysuria
|
0.05%
1/1996 • Number of events 1
|
0.20%
4/2037 • Number of events 4
|
|
Renal and urinary disorders
Haematuria
|
0.30%
6/1996 • Number of events 6
|
0.44%
9/2037 • Number of events 9
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Renal and urinary disorders
Nephropathy
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Renal and urinary disorders
Polyuria
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Renal and urinary disorders
Renal colic
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Renal and urinary disorders
Renal cyst
|
0.10%
2/1996 • Number of events 2
|
0.10%
2/2037 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
0.45%
9/1996 • Number of events 9
|
0.39%
8/2037 • Number of events 8
|
|
Renal and urinary disorders
Renal failure acute
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Renal and urinary disorders
Renal failure chronic
|
0.30%
6/1996 • Number of events 6
|
0.25%
5/2037 • Number of events 5
|
|
Renal and urinary disorders
Strangury
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Renal and urinary disorders
Urinary retention
|
0.20%
4/1996 • Number of events 5
|
0.10%
2/2037 • Number of events 2
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.07%
1/1438 • Number of events 1
|
0.00%
0/1485
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1438
|
0.13%
2/1485 • Number of events 2
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.07%
1/1438 • Number of events 1
|
0.00%
0/1485
|
|
Reproductive system and breast disorders
Epididymitis
|
0.07%
1/1438 • Number of events 1
|
0.00%
0/1485
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.28%
4/1438 • Number of events 4
|
0.07%
1/1485 • Number of events 1
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.07%
1/1438 • Number of events 1
|
0.07%
1/1485 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/558
|
0.36%
2/552 • Number of events 2
|
|
Reproductive system and breast disorders
Penis disorder
|
0.00%
0/1438
|
0.07%
1/1485 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatic calcification
|
0.07%
1/1438 • Number of events 1
|
0.00%
0/1485
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/1438
|
0.07%
1/1485 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.18%
1/558 • Number of events 1
|
0.36%
2/552 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.35%
7/1996 • Number of events 7
|
0.10%
2/2037 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.75%
15/1996 • Number of events 15
|
1.1%
22/2037 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.90%
18/1996 • Number of events 19
|
1.0%
21/2037 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.10%
2/1996 • Number of events 2
|
0.25%
5/2037 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
28/1996 • Number of events 30
|
1.9%
38/2037 • Number of events 48
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.05%
1/1996 • Number of events 1
|
0.10%
2/2037 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.25%
5/1996 • Number of events 5
|
0.15%
3/2037 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.05%
1/1996 • Number of events 1
|
0.25%
5/2037 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.05%
1/1996 • Number of events 3
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.20%
4/1996 • Number of events 4
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.20%
4/1996 • Number of events 5
|
0.20%
4/2037 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.15%
3/1996 • Number of events 3
|
0.20%
4/2037 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.60%
12/1996 • Number of events 12
|
0.49%
10/2037 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.15%
3/1996 • Number of events 3
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.55%
11/1996 • Number of events 11
|
0.29%
6/2037 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.10%
2/1996 • Number of events 2
|
0.20%
4/2037 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.15%
3/1996 • Number of events 3
|
0.15%
3/2037 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.65%
13/1996 • Number of events 13
|
0.20%
4/2037 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.15%
3/1996 • Number of events 3
|
0.10%
2/2037 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Xanthoma
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Surgical and medical procedures
Bladder catheter removal
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Surgical and medical procedures
Blood product transfusion
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/1996
|
0.15%
3/2037 • Number of events 3
|
|
Surgical and medical procedures
Carotid angioplasty
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.10%
2/1996 • Number of events 2
|
0.25%
5/2037 • Number of events 5
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Surgical and medical procedures
Dialysis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Surgical and medical procedures
Heart valve operation
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Surgical and medical procedures
Packed red blood cell transfusion
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.70%
14/1996 • Number of events 14
|
0.39%
8/2037 • Number of events 8
|
|
Surgical and medical procedures
Platelet transfusion
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Surgical and medical procedures
Thromboembolectomy
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Aneurysm
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Angiopathy
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Aortic calcification
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Aortic dilatation
|
0.05%
1/1996 • Number of events 1
|
0.15%
3/2037 • Number of events 3
|
|
Vascular disorders
Aortic disorder
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Aortic stenosis
|
0.25%
5/1996 • Number of events 5
|
0.15%
3/2037 • Number of events 3
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Arterial stenosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Arteriosclerosis
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Artery dissection
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Blood pressure fluctuation
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Vascular disorders
Embolism
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Femoral artery dissection
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Flushing
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Haematoma
|
2.9%
57/1996 • Number of events 62
|
4.7%
96/2037 • Number of events 97
|
|
Vascular disorders
Haemodynamic instability
|
0.10%
2/1996 • Number of events 2
|
0.00%
0/2037
|
|
Vascular disorders
Haemorrhage
|
0.50%
10/1996 • Number of events 10
|
0.64%
13/2037 • Number of events 13
|
|
Vascular disorders
Hypertension
|
4.4%
88/1996 • Number of events 88
|
4.4%
90/2037 • Number of events 90
|
|
Vascular disorders
Hypertensive crisis
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.2%
23/1996 • Number of events 23
|
1.4%
28/2037 • Number of events 29
|
|
Vascular disorders
Ischaemia
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Macroangiopathy
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Orthostatic hypotension
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.20%
4/1996 • Number of events 4
|
0.20%
4/2037 • Number of events 4
|
|
Vascular disorders
Peripheral artery dissection
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/1996
|
0.10%
2/2037 • Number of events 2
|
|
Vascular disorders
Peripheral embolism
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
|
Vascular disorders
Phlebitis
|
0.20%
4/1996 • Number of events 4
|
0.15%
3/2037 • Number of events 3
|
|
Vascular disorders
Raynaud's phenomenon
|
0.05%
1/1996 • Number of events 1
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Reperfusion injury
|
0.15%
3/1996 • Number of events 3
|
0.15%
3/2037 • Number of events 3
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.30%
6/1996 • Number of events 7
|
0.20%
4/2037 • Number of events 4
|
|
Vascular disorders
Varicose vein ruptured
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Vascular occlusion
|
0.10%
2/1996 • Number of events 2
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Vasospasm
|
0.10%
2/1996 • Number of events 3
|
0.10%
2/2037 • Number of events 2
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/1996
|
0.05%
1/2037 • Number of events 1
|
|
Vascular disorders
Venous thrombosis limb
|
0.05%
1/1996 • Number of events 1
|
0.00%
0/2037
|
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