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Trial Outcomes & Findings for A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome (NCT NCT00391872)

NCT ID: NCT00391872

Last Updated: 2012-03-13

Results Overview

Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18624 participants

Primary outcome timeframe

Randomization up to 12 months

Results posted on

2012-03-13

Participant Flow

The first participant was enrolled on 11 October 2006 and the last participant completed the study on 27 February 2009. Study participants were randomized from 855 centers in 43 countries.

Participants will already be hospitalized due to their acute condition, and must be enrolled and randomized within 24 hours of the onset of their most recent cardiac ischemic symptoms. Randomization should take place as soon as possible after presentation.

Participant milestones

Participant milestones
Measure
TICAGRELOR
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
Clopidogrel 75 mg once daily dose (ODD)
Overall Study
STARTED
9333
9291
Overall Study
COMPLETED
9026
9036
Overall Study
NOT COMPLETED
307
255

Reasons for withdrawal

Reasons for withdrawal
Measure
TICAGRELOR
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
Clopidogrel 75 mg once daily dose (ODD)
Overall Study
Protocol Violation
7
2
Overall Study
Withdrawal by Subject
296
249
Overall Study
Reason unknown
2
4
Overall Study
Lost to Follow-up
2
0

Baseline Characteristics

A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TICAGRELOR
n=9333 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9291 Participants
Clopidogrel 75 mg once daily dose (ODD)
Total
n=18624 Participants
Total of all reporting groups
Age Continuous
62.1 years
STANDARD_DEVIATION 11.21 • n=5 Participants
62.3 years
STANDARD_DEVIATION 11.21 • n=7 Participants
62.2 years
STANDARD_DEVIATION 22.42 • n=5 Participants
Sex: Female, Male
Female
2655 Participants
n=5 Participants
2633 Participants
n=7 Participants
5288 Participants
n=5 Participants
Sex: Female, Male
Male
6678 Participants
n=5 Participants
6658 Participants
n=7 Participants
13336 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Randomization up to 12 months

Population: The population was the full analysis set, which included all randomized patients

Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9333 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9291 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
864 Participants
1014 Participants

PRIMARY outcome

Timeframe: First dosing up to 12 months

Population: The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug

Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9235 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9186 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Any Major Bleeding Event
961 Participants
929 Participants

SECONDARY outcome

Timeframe: Randomization up to 12 months

Population: The subgroup of patients with intent for invasive management at randomization

Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=6732 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=6676 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
569 Participants
668 Participants

SECONDARY outcome

Timeframe: Randomization up to 12 months

Population: The population was the full analysis set, which included all randomized patients

Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9333 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9291 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
901 Participants
1065 Participants

SECONDARY outcome

Timeframe: Randomization up to 12 months

Population: The population was the full analysis set, which included all randomized patients

Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9333 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9291 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
1290 Participants
1456 Participants

SECONDARY outcome

Timeframe: Randomization up to 12 months

Population: The population was the full analysis set, which included all randomized patients

Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9333 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9291 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With MI Event
504 Participants
593 Participants

SECONDARY outcome

Timeframe: Randomization up to 12 months

Population: The population was the full analysis set, which included all randomized patients

Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9333 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9291 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Death From Vascular Causes
353 Participants
442 Participants

SECONDARY outcome

Timeframe: Randomization up to 12 months

Population: The population was the full analysis set, which included all randomized patients

Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9333 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9291 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Stroke
125 Participants
106 Participants

SECONDARY outcome

Timeframe: Randomization up to 12 months

Population: The population was the full analysis set, which included all randomized patients

Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9333 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9291 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Death From Any Cause
399 Participants
506 Participants

SECONDARY outcome

Timeframe: First dosing up to 12 months

Population: The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug

Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9235 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9186 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
362 Participants
306 Participants

SECONDARY outcome

Timeframe: First dosing up to 12 months

Population: The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug

Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9235 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9186 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Major or Minor Bleeding
1339 Participants
1215 Participants

SECONDARY outcome

Timeframe: First dosing up to 12 months

Population: The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug

Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=9235 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=9186 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Non-procedural Major Bleeding
235 Participants
180 Participants

SECONDARY outcome

Timeframe: First dosing up to 12 months

Population: Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.

Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=770 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=814 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
619 Participants
654 Participants

SECONDARY outcome

Timeframe: First dosing up to 12 months

Population: Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.

Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=770 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=814 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
329 Participants
341 Participants

SECONDARY outcome

Timeframe: 1-week period following randomization

Population: Participants with Holter data in the week after Randomization

Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=1451 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=1415 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
84 Participants
51 Participants

SECONDARY outcome

Timeframe: 1-week period following randomization

Population: Patients who were monitored for one week following randomization (and for one week one month later).

Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.

Outcome measures

Outcome measures
Measure
TICAGRELOR
n=964 Participants
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
n=985 Participants
Clopidogrel 75 mg once daily dose (ODD)
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
21 Participants
16 Participants

Adverse Events

TICAGRELOR

Serious events: 2108 serious events
Other events: 2278 other events
Deaths: 0 deaths

CLOPIDOGREL

Serious events: 2117 serious events
Other events: 1665 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
TICAGRELOR
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
Clopidogrel 75 mg once daily dose (ODD)
Injury, poisoning and procedural complications
Joint Dislocation
0.01%
1/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Joint Injury
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Spinal Compression Fracture
0.02%
2/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Stent Occlusion
0.01%
1/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Traumatic Haemorrhage
0.01%
1/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Upper Limb Fracture
0.01%
1/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Vascular Graft Occlusion
0.02%
2/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Anaemia Postoperative
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Ankle Fracture
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Brain Contusion
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Cardiac Pacemaker Malfunction
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Cardiac Procedure Complication
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Chest Injury
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Contrast Media Reaction
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Contusion
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Coronary Artery Reocclusion
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Device Breakage
0.01%
1/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Device Dislocation
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Device Malfunction
0.01%
1/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Device Migration
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Fat Embolism
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Forearm Fracture
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Fracture
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Fractured Ischium
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Implantable Defibrillator Malfunction
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Incision Site Haemorrhage
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Incisional Hernia
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Joint Sprain
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Meniscus Lesion
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Open Wound
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Pelvic Fracture
0.01%
1/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Post Procedural Haematuria
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Procedural Complication
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Radius Fracture
0.01%
1/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Rib Fracture
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Road Traffic Accident
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Scrotal Haematoma
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Suture Rupture
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Tendon Rupture
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Thermal Burn
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Tibia Fracture
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Tracheal Haemorrhage
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Tracheal Obstruction
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Transfusion Reaction
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Traumatic Intracranial Haemorrhage
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Ulna Fracture
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Urinary Bladder Rupture
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Urinary Retention Postoperative
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Vascular Procedure Complication
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm Ruptured
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Vertebral Injury
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Weaning Failure
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Wound Complication
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Haemoglobin Decreased
0.06%
6/9333
0.09%
8/9291
Injury, poisoning and procedural complications
Aspartate Aminotransferase Increased
0.01%
1/9333
0.04%
4/9291
Injury, poisoning and procedural complications
Alanine Aminotransferase Increased
0.01%
1/9333
0.03%
3/9291
Injury, poisoning and procedural complications
Blood Pressure Increased
0.03%
3/9333
0.03%
3/9291
Injury, poisoning and procedural complications
Liver Function Test Abnormal
0.02%
2/9333
0.03%
3/9291
Injury, poisoning and procedural complications
Angiogram
0.02%
2/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Blood Glucose Increased
0.02%
2/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Blood Potassium Increased
0.00%
0/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Body Temperature Increased
0.02%
2/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Hepatic Enzyme Increased
0.02%
2/9333
0.02%
2/9291
Injury, poisoning and procedural complications
International Normalised Ratio Increased
0.01%
1/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Troponin Increased
0.01%
1/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Antiphospholipid Antibodies
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Blood Creatine Phosphokinase Increased
0.01%
1/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Blood Creatinine Increased
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Blood Potassium Decreased
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Blood Pressure Decreased
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Blood Sodium Decreased
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Blood Urine Present
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
C-Reactive Protein Increased
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Cardiac Enzymes Increased
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Cardiac Stress Test Abnormal
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Electrocardiogram Qt Prolonged
0.01%
1/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Electrocardiogram T Wave Inversion
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Fibrin D Dimer Increased
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Heart Rate Increased
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Intraocular Pressure Increased
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Occult Blood
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Pancreatic Enzymes Increased
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Platelet Count Decreased
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Prostatic Specific Antigen Abnormal
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Prostatic Specific Antigen Increased
0.01%
1/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Weight Decreased
0.01%
1/9333
0.01%
1/9291
Metabolism and nutrition disorders
Dehydration
0.12%
11/9333
0.05%
5/9291
Metabolism and nutrition disorders
Hypoglycaemia
0.12%
11/9333
0.09%
8/9291
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
0.03%
3/9333
0.10%
9/9291
Metabolism and nutrition disorders
Diabetes Mellitus
0.06%
6/9333
0.08%
7/9291
Metabolism and nutrition disorders
Hyperglycaemia
0.08%
7/9333
0.02%
2/9291
Infections and infestations
Orchitis
0.00%
0/9333
0.01%
1/9291
Metabolism and nutrition disorders
Hyperkalaemia
0.01%
1/9333
0.04%
4/9291
Metabolism and nutrition disorders
Anorexia
0.03%
3/9333
0.00%
0/9291
Metabolism and nutrition disorders
Hyponatraemia
0.03%
3/9333
0.01%
1/9291
Metabolism and nutrition disorders
Diabetic Ketoacidosis
0.02%
2/9333
0.01%
1/9291
Metabolism and nutrition disorders
Fluid Overload
0.00%
0/9333
0.02%
2/9291
Metabolism and nutrition disorders
Gout
0.02%
2/9333
0.02%
2/9291
Metabolism and nutrition disorders
Metabolic Acidosis
0.00%
0/9333
0.02%
2/9291
Metabolism and nutrition disorders
Metabolic Disorder
0.00%
0/9333
0.02%
2/9291
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
0.02%
2/9333
0.02%
2/9291
Metabolism and nutrition disorders
Diabetic Foot
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Bursitis
0.02%
2/9333
0.01%
1/9291
Metabolism and nutrition disorders
Electrolyte Depletion
0.00%
0/9333
0.01%
1/9291
Metabolism and nutrition disorders
Failure To Thrive
0.00%
0/9333
0.01%
1/9291
Metabolism and nutrition disorders
Hyperosmolar State
0.00%
0/9333
0.01%
1/9291
Metabolism and nutrition disorders
Hypokalaemia
0.01%
1/9333
0.01%
1/9291
Metabolism and nutrition disorders
Hypovolaemia
0.01%
1/9333
0.00%
0/9291
Metabolism and nutrition disorders
Ketoacidosis
0.01%
1/9333
0.00%
0/9291
Metabolism and nutrition disorders
Metabolic Syndrome
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
0.16%
15/9333
0.17%
16/9291
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.08%
7/9333
0.05%
5/9291
Musculoskeletal and connective tissue disorders
Back Pain
0.03%
3/9333
0.06%
6/9291
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
0.05%
5/9333
0.04%
4/9291
Musculoskeletal and connective tissue disorders
Arthralgia
0.03%
3/9333
0.04%
4/9291
Musculoskeletal and connective tissue disorders
Myalgia
0.03%
3/9333
0.03%
3/9291
Musculoskeletal and connective tissue disorders
Pain In Extremity
0.03%
3/9333
0.02%
2/9291
Musculoskeletal and connective tissue disorders
Arthritis
0.02%
2/9333
0.02%
2/9291
Musculoskeletal and connective tissue disorders
Bone Pain
0.01%
1/9333
0.02%
2/9291
Musculoskeletal and connective tissue disorders
Costochondritis
0.02%
2/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Gouty Arthritis
0.02%
2/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Myalgia Intercostal
0.02%
2/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Neck Pain
0.01%
1/9333
0.02%
2/9291
Musculoskeletal and connective tissue disorders
Chondropathy
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Dupuytren's Contracture
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Groin Pain
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Central Nervous System Lesion
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Cerebellar Infarction
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.01%
1/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Joint Swelling
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Monarthritis
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Muscle Tightness
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.01%
1/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Myositis
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Osteochondrosis
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Osteolysis
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Osteoporosis
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Pain In Jaw
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Pathological Fracture
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Polyarthritis
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Polymyositis
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.01%
1/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Spinal Disorder
0.01%
1/9333
0.00%
0/9291
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
0.00%
0/9333
0.01%
1/9291
Musculoskeletal and connective tissue disorders
Wrist Deformity
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Bacterial Infection
0.01%
1/9333
0.01%
1/9291
Blood and lymphatic system disorders
Anaemia
0.38%
35/9333
0.27%
25/9291
Blood and lymphatic system disorders
Thrombocytopenia
0.08%
7/9333
0.09%
8/9291
Blood and lymphatic system disorders
Iron Deficiency Anaemia
0.02%
2/9333
0.06%
6/9291
Blood and lymphatic system disorders
Leukopenia
0.01%
1/9333
0.02%
2/9291
Blood and lymphatic system disorders
Lymphadenitis
0.02%
2/9333
0.00%
0/9291
Blood and lymphatic system disorders
Microcytic Anaemia
0.01%
1/9333
0.02%
2/9291
Blood and lymphatic system disorders
Spontaneous Haematoma
0.02%
2/9333
0.00%
0/9291
Blood and lymphatic system disorders
Coagulopathy
0.01%
1/9333
0.00%
0/9291
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
0.00%
0/9333
0.01%
1/9291
Blood and lymphatic system disorders
Granulocytopenia
0.01%
1/9333
0.00%
0/9291
Blood and lymphatic system disorders
Haemorrhagic Anaemia
0.01%
1/9333
0.00%
0/9291
Blood and lymphatic system disorders
Hypochromic Anaemia
0.01%
1/9333
0.00%
0/9291
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/9333
0.01%
1/9291
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/9333
0.01%
1/9291
Blood and lymphatic system disorders
Nephrogenic Anaemia
0.01%
1/9333
0.00%
0/9291
Blood and lymphatic system disorders
Neutropenia
0.01%
1/9333
0.01%
1/9291
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
0.01%
1/9333
0.00%
0/9291
Blood and lymphatic system disorders
Pancytopenia
0.01%
1/9333
0.00%
0/9291
Blood and lymphatic system disorders
Polycythaemia
0.01%
1/9333
0.01%
1/9291
Blood and lymphatic system disorders
Splenic Lesion
0.01%
1/9333
0.00%
0/9291
Blood and lymphatic system disorders
Thrombocythaemia
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Cardiac Failure
1.3%
122/9333
1.4%
129/9291
Cardiac disorders
Atrial Fibrillation
0.75%
70/9333
0.73%
68/9291
Cardiac disorders
Cardiogenic Shock
0.64%
60/9333
0.71%
66/9291
Cardiac disorders
Ventricular Fibrillation
0.51%
48/9333
0.69%
64/9291
Cardiac disorders
Cardiac Failure Congestive
0.55%
51/9333
0.50%
46/9291
Cardiac disorders
Cardiac Arrest
0.41%
38/9333
0.47%
44/9291
Cardiac disorders
Ventricular Tachycardia
0.31%
29/9333
0.36%
33/9291
Cardiac disorders
Bradycardia
0.28%
26/9333
0.33%
31/9291
Cardiac disorders
Atrioventricular Block Complete
0.20%
19/9333
0.20%
19/9291
Cardiac disorders
Cardiac Failure Acute
0.19%
18/9333
0.19%
18/9291
Cardiac disorders
Cardiac Tamponade
0.12%
11/9333
0.17%
16/9291
Cardiac disorders
Intracardiac Thrombus
0.14%
13/9333
0.16%
15/9291
Cardiac disorders
Angina Pectoris
0.08%
7/9333
0.15%
14/9291
Cardiac disorders
Cardio-Respiratory Arrest
0.09%
8/9333
0.13%
12/9291
Cardiac disorders
Atrial Flutter
0.12%
11/9333
0.08%
7/9291
Cardiac disorders
Left Ventricular Failure
0.11%
10/9333
0.05%
5/9291
Cardiac disorders
Pericardial Effusion
0.10%
9/9333
0.11%
10/9291
Cardiac disorders
Arrhythmia
0.09%
8/9333
0.04%
4/9291
Cardiac disorders
Palpitations
0.09%
8/9333
0.08%
7/9291
Cardiac disorders
Pericarditis
0.06%
6/9333
0.09%
8/9291
Cardiac disorders
Supraventricular Tachycardia
0.09%
8/9333
0.09%
8/9291
Cardiac disorders
Sick Sinus Syndrome
0.08%
7/9333
0.02%
2/9291
Cardiac disorders
Cardiac Asthma
0.03%
3/9333
0.06%
6/9291
Cardiac disorders
Mitral Valve Incompetence
0.04%
4/9333
0.06%
6/9291
Cardiac disorders
Ventricular Arrhythmia
0.03%
3/9333
0.06%
6/9291
Cardiac disorders
Ventricular Extrasystoles
0.06%
6/9333
0.01%
1/9291
Cardiac disorders
Atrioventricular Block
0.03%
3/9333
0.05%
5/9291
Cardiac disorders
Cardiac Failure Chronic
0.05%
5/9333
0.02%
2/9291
Cardiac disorders
Coronary Artery Disease
0.05%
5/9333
0.03%
3/9291
Cardiac disorders
Coronary Artery Dissection
0.05%
5/9333
0.03%
3/9291
Cardiac disorders
Atrioventricular Block Second Degree
0.04%
4/9333
0.00%
0/9291
Cardiac disorders
Electromechanical Dissociation
0.03%
3/9333
0.04%
4/9291
Cardiac disorders
Myocardial Rupture
0.02%
2/9333
0.04%
4/9291
Cardiac disorders
Sinus Bradycardia
0.01%
1/9333
0.04%
4/9291
Cardiac disorders
Tachyarrhythmia
0.04%
4/9333
0.04%
4/9291
Cardiac disorders
Tachycardia
0.01%
1/9333
0.04%
4/9291
Cardiac disorders
Acute Left Ventricular Failure
0.03%
3/9333
0.02%
2/9291
Cardiac disorders
Aortic Valve Stenosis
0.02%
2/9333
0.03%
3/9291
Cardiac disorders
Atrial Tachycardia
0.01%
1/9333
0.03%
3/9291
Cardiac disorders
Bradyarrhythmia
0.03%
3/9333
0.03%
3/9291
Cardiac disorders
Cardiac Aneurysm
0.01%
1/9333
0.03%
3/9291
Cardiac disorders
Cardiomyopathy
0.01%
1/9333
0.03%
3/9291
Cardiac disorders
Coronary Artery Perforation
0.03%
3/9333
0.00%
0/9291
Cardiac disorders
Coronary Artery Thrombosis
0.02%
2/9333
0.03%
3/9291
Cardiac disorders
Dressler's Syndrome
0.03%
3/9333
0.03%
3/9291
Cardiac disorders
Left Ventricular Dysfunction
0.03%
3/9333
0.03%
3/9291
Cardiac disorders
Pericardial Haemorrhage
0.03%
3/9333
0.02%
2/9291
Cardiac disorders
Sinus Arrest
0.01%
1/9333
0.03%
3/9291
Cardiac disorders
Ventricle Rupture
0.02%
2/9333
0.03%
3/9291
Infections and infestations
Breast Abscess
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Arrhythmia Supraventricular
0.01%
1/9333
0.02%
2/9291
Cardiac disorders
Arteriosclerosis Coronary Artery
0.00%
0/9333
0.02%
2/9291
Cardiac disorders
Cardiopulmonary Failure
0.01%
1/9333
0.02%
2/9291
Cardiac disorders
Coronary Artery Occlusion
0.00%
0/9333
0.02%
2/9291
Cardiac disorders
Coronary Artery Stenosis
0.02%
2/9333
0.01%
1/9291
Cardiac disorders
Nodal Rhythm
0.01%
1/9333
0.02%
2/9291
Cardiac disorders
Papillary Muscle Rupture
0.02%
2/9333
0.01%
1/9291
Cardiac disorders
Right Ventricular Failure
0.02%
2/9333
0.01%
1/9291
General disorders
Inflammation Of Wound
0.01%
1/9333
0.00%
0/9291
Cardiac disorders
Acute Coronary Syndrome
0.01%
1/9333
0.01%
1/9291
General disorders
Injection Site Haemorrhage
0.01%
1/9333
0.00%
0/9291
Cardiac disorders
Arteriospasm Coronary
0.01%
1/9333
0.00%
0/9291
Cardiac disorders
Atrial Rupture
0.01%
1/9333
0.00%
0/9291
Cardiac disorders
Bundle Branch Block
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Bundle Branch Block Left
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Cardiac Disorder
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Cardiac Valve Disease
0.01%
1/9333
0.00%
0/9291
Cardiac disorders
Cardiovascular Disorder
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Chordae Tendinae Rupture
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Coronary Artery Insufficiency
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Cyanosis
0.01%
1/9333
0.00%
0/9291
Cardiac disorders
Dissecting Coronary Artery Aneurysm
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Extrasystoles
0.01%
1/9333
0.01%
1/9291
Cardiac disorders
Hypertrophic Cardiomyopathy
0.01%
1/9333
0.01%
1/9291
Cardiac disorders
Interventricular Septum Rupture
0.01%
1/9333
0.00%
0/9291
Cardiac disorders
Ischaemic Cardiomyopathy
0.01%
1/9333
0.00%
0/9291
Cardiac disorders
Long Qt Syndrome
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Low Cardiac Output Syndrome
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Myocardial Infarction
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Myocardial Ischaemia
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Myocarditis
0.01%
1/9333
0.00%
0/9291
Cardiac disorders
Papillary Muscle Disorder
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Stress Cardiomyopathy
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Torsade De Pointes
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Ventricular Dysfunction
0.00%
0/9333
0.01%
1/9291
Cardiac disorders
Ventricular Tachyarrhythmia
0.00%
0/9333
0.01%
1/9291
Congenital, familial and genetic disorders
Carbohydrate Metabolism Disorder
0.00%
0/9333
0.02%
2/9291
Congenital, familial and genetic disorders
Diverticulitis Meckel's
0.01%
1/9333
0.00%
0/9291
Congenital, familial and genetic disorders
Gastrointestinal Angiodysplasia Haemorrhagic
0.00%
0/9333
0.01%
1/9291
Congenital, familial and genetic disorders
Haemorrhagic Arteriovenous Malformation
0.01%
1/9333
0.00%
0/9291
Congenital, familial and genetic disorders
Ventricular Septal Defect
0.00%
0/9333
0.01%
1/9291
Ear and labyrinth disorders
Vertigo
0.09%
8/9333
0.05%
5/9291
Ear and labyrinth disorders
Vestibular Neuronitis
0.01%
1/9333
0.03%
3/9291
Ear and labyrinth disorders
Hypoacusis
0.02%
2/9333
0.00%
0/9291
Ear and labyrinth disorders
Deafness
0.01%
1/9333
0.00%
0/9291
Ear and labyrinth disorders
Sudden Hearing Loss
0.00%
0/9333
0.01%
1/9291
Ear and labyrinth disorders
Tinnitus
0.01%
1/9333
0.00%
0/9291
Ear and labyrinth disorders
Vertigo Positional
0.01%
1/9333
0.00%
0/9291
Endocrine disorders
Hyperthyroidism
0.02%
2/9333
0.02%
2/9291
Endocrine disorders
Goitre
0.00%
0/9333
0.01%
1/9291
Endocrine disorders
Pituitary-Dependent Cushing's Syndrome
0.01%
1/9333
0.00%
0/9291
Endocrine disorders
Thyrotoxic Crisis
0.00%
0/9333
0.01%
1/9291
Eye disorders
Cataract
0.03%
3/9333
0.02%
2/9291
Eye disorders
Diplopia
0.02%
2/9333
0.01%
1/9291
Eye disorders
Retinal Detachment
0.02%
2/9333
0.02%
2/9291
Eye disorders
Amaurosis
0.01%
1/9333
0.00%
0/9291
Eye disorders
Amaurosis Fugax
0.00%
0/9333
0.01%
1/9291
Eye disorders
Blindness
0.01%
1/9333
0.00%
0/9291
Eye disorders
Cataract Nuclear
0.01%
1/9333
0.00%
0/9291
Eye disorders
Chorioretinitis
0.00%
0/9333
0.01%
1/9291
Eye disorders
Conjunctival Haemorrhage
0.01%
1/9333
0.00%
0/9291
Eye disorders
Diabetic Retinopathy
0.01%
1/9333
0.00%
0/9291
Eye disorders
Eye Haemorrhage
0.01%
1/9333
0.01%
1/9291
Eye disorders
Glaucoma
0.01%
1/9333
0.00%
0/9291
Eye disorders
Macular Degeneration
0.01%
1/9333
0.01%
1/9291
Eye disorders
Posterior Capsule Opacification
0.00%
0/9333
0.01%
1/9291
Eye disorders
Retinal Artery Embolism
0.00%
0/9333
0.01%
1/9291
Eye disorders
Visual Impairment
0.01%
1/9333
0.01%
1/9291
Eye disorders
Vitreous Haemorrhage
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Gastrointestinal Haemorrhage
0.48%
45/9333
0.45%
42/9291
Gastrointestinal disorders
Abdominal Pain
0.23%
21/9333
0.11%
10/9291
Gastrointestinal disorders
Abdominal Pain Upper
0.10%
9/9333
0.16%
15/9291
Gastrointestinal disorders
Diarrhoea
0.13%
12/9333
0.10%
9/9291
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
0.12%
11/9333
0.06%
6/9291
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
0.11%
10/9333
0.02%
2/9291
Gastrointestinal disorders
Melaena
0.11%
10/9333
0.03%
3/9291
Gastrointestinal disorders
Vomiting
0.11%
10/9333
0.04%
4/9291
Gastrointestinal disorders
Gastritis
0.09%
8/9333
0.10%
9/9291
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
0.10%
9/9333
0.08%
7/9291
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
0.04%
4/9333
0.08%
7/9291
Gastrointestinal disorders
Rectal Haemorrhage
0.08%
7/9333
0.06%
6/9291
Gastrointestinal disorders
Dyspepsia
0.06%
6/9333
0.05%
5/9291
Gastrointestinal disorders
Haematemesis
0.05%
5/9333
0.03%
3/9291
Gastrointestinal disorders
Pancreatitis
0.04%
4/9333
0.05%
5/9291
Gastrointestinal disorders
Pancreatitis Acute
0.05%
5/9333
0.01%
1/9291
Gastrointestinal disorders
Retroperitoneal Haemorrhage
0.05%
5/9333
0.03%
3/9291
Gastrointestinal disorders
Gastric Haemorrhage
0.03%
3/9333
0.04%
4/9291
Gastrointestinal disorders
Gastric Ulcer
0.04%
4/9333
0.02%
2/9291
Gastrointestinal disorders
Gastritis Erosive
0.04%
4/9333
0.02%
2/9291
Gastrointestinal disorders
Haematochezia
0.04%
4/9333
0.02%
2/9291
Gastrointestinal disorders
Inguinal Hernia
0.04%
4/9333
0.04%
4/9291
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
0.01%
1/9333
0.04%
4/9291
Gastrointestinal disorders
Nausea
0.03%
3/9333
0.04%
4/9291
Gastrointestinal disorders
Anal Haemorrhage
0.00%
0/9333
0.03%
3/9291
Gastrointestinal disorders
Diverticulum
0.03%
3/9333
0.00%
0/9291
Gastrointestinal disorders
Duodenal Ulcer
0.03%
3/9333
0.02%
2/9291
Gastrointestinal disorders
Enteritis
0.00%
0/9333
0.03%
3/9291
Gastrointestinal disorders
Gastrointestinal Necrosis
0.03%
3/9333
0.00%
0/9291
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
0.02%
2/9333
0.03%
3/9291
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
0.03%
3/9333
0.01%
1/9291
Gastrointestinal disorders
Peritonitis
0.01%
1/9333
0.03%
3/9291
Gastrointestinal disorders
Retroperitoneal Haematoma
0.03%
3/9333
0.03%
3/9291
Gastrointestinal disorders
Abdominal Discomfort
0.00%
0/9333
0.02%
2/9291
Gastrointestinal disorders
Constipation
0.01%
1/9333
0.02%
2/9291
Gastrointestinal disorders
Diverticulum Intestinal
0.02%
2/9333
0.00%
0/9291
Gastrointestinal disorders
Diverticulum Intestinal Haemorrhagic
0.01%
1/9333
0.02%
2/9291
Gastrointestinal disorders
Duodenitis
0.00%
0/9333
0.02%
2/9291
Gastrointestinal disorders
Dysphagia
0.02%
2/9333
0.02%
2/9291
Gastrointestinal disorders
Faeces Discoloured
0.02%
2/9333
0.00%
0/9291
Gastrointestinal disorders
Gastric Disorder
0.00%
0/9333
0.02%
2/9291
Gastrointestinal disorders
Gastritis Haemorrhagic
0.01%
1/9333
0.02%
2/9291
Gastrointestinal disorders
Gastroduodenal Haemorrhage
0.02%
2/9333
0.00%
0/9291
Gastrointestinal disorders
Ileus Paralytic
0.02%
2/9333
0.00%
0/9291
Gastrointestinal disorders
Intestinal Haemorrhage
0.01%
1/9333
0.02%
2/9291
Gastrointestinal disorders
Intestinal Ischaemia
0.00%
0/9333
0.02%
2/9291
Gastrointestinal disorders
Large Intestine Perforation
0.02%
2/9333
0.01%
1/9291
Gastrointestinal disorders
Oesophagitis
0.01%
1/9333
0.02%
2/9291
Gastrointestinal disorders
Rectal Polyp
0.02%
2/9333
0.00%
0/9291
Gastrointestinal disorders
Small Intestinal Obstruction
0.02%
2/9333
0.01%
1/9291
Gastrointestinal disorders
Abdominal Hernia Obstructive
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Anal Fistula
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Appendicitis Perforated
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Ascites
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Colitis Ischaemic
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Colitis Ulcerative
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Colonic Polyp
0.01%
1/9333
0.01%
1/9291
Gastrointestinal disorders
Dental Caries
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Diarrhoea Haemorrhagic
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Diverticular Perforation
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Diverticulitis Intestinal Haemorrhagic
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Enterocolitis Haemorrhagic
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Epigastric Discomfort
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Erosive Oesophagitis
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Faecal Incontinence
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Food Poisoning
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Gastritis Atrophic
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Gastrointestinal Disorder
0.01%
1/9333
0.01%
1/9291
Gastrointestinal disorders
Gastrointestinal Pain
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Gastrointestinal Ulcer Haemorrhage
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Gingival Bleeding
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Gingivitis Ulcerative
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Haemorrhagic Erosive Gastritis
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Haemorrhoids
0.01%
1/9333
0.01%
1/9291
Gastrointestinal disorders
Hiatus Hernia
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Inguinal Hernia Strangulated
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Intestinal Obstruction
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Intestinal Polyp
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Intra-Abdominal Haemorrhage
0.01%
1/9333
0.01%
1/9291
Gastrointestinal disorders
Mallory-Weiss Syndrome
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Mesenteric Artery Embolism
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Mouth Haemorrhage
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Oesophageal Food Impaction
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Oesophageal Haemorrhage
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Oesophageal Pain
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Oesophagitis Haemorrhagic
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Pancreatic Disorder
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Pancreatic Haemorrhage
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Pancreatitis Chronic
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Peptic Ulcer
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Pneumoperitoneum
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Polyp Colorectal
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Proctitis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Bronchiectasis
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Reflux Oesophagitis
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Retroperitoneal Fibrosis
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Small Intestinal Haemorrhage
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Small Intestinal Perforation
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Stomach Mass
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Subileus
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Thrombosis Mesenteric Vessel
0.00%
0/9333
0.01%
1/9291
Gastrointestinal disorders
Tongue Oedema
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Toothache
0.01%
1/9333
0.00%
0/9291
Gastrointestinal disorders
Volvulus
0.00%
0/9333
0.01%
1/9291
General disorders
Non-Cardiac Chest Pain
1.1%
101/9333
1.1%
103/9291
General disorders
Chest Pain
0.58%
54/9333
0.68%
63/9291
General disorders
Death
0.23%
21/9333
0.33%
31/9291
General disorders
Sudden Death
0.18%
17/9333
0.29%
27/9291
General disorders
Sudden Cardiac Death
0.15%
14/9333
0.27%
25/9291
General disorders
Vessel Puncture Site Haematoma
0.09%
8/9333
0.13%
12/9291
General disorders
Pyrexia
0.11%
10/9333
0.05%
5/9291
General disorders
Multi-Organ Failure
0.10%
9/9333
0.10%
9/9291
General disorders
Vessel Puncture Site Haemorrhage
0.10%
9/9333
0.06%
6/9291
General disorders
Asthenia
0.06%
6/9333
0.04%
4/9291
General disorders
Malaise
0.06%
6/9333
0.03%
3/9291
General disorders
General Physical Health Deterioration
0.01%
1/9333
0.05%
5/9291
General disorders
Chest Discomfort
0.04%
4/9333
0.02%
2/9291
General disorders
Impaired Healing
0.01%
1/9333
0.04%
4/9291
General disorders
Oedema Peripheral
0.04%
4/9333
0.01%
1/9291
General disorders
Puncture Site Haemorrhage
0.04%
4/9333
0.01%
1/9291
General disorders
Cardiac Death
0.03%
3/9333
0.01%
1/9291
General disorders
Catheter Site Haemorrhage
0.01%
1/9333
0.02%
2/9291
General disorders
Fatigue
0.01%
1/9333
0.02%
2/9291
Infections and infestations
Bronchitis Viral
0.00%
0/9333
0.01%
1/9291
General disorders
Systemic Inflammatory Response Syndrome
0.01%
1/9333
0.02%
2/9291
General disorders
Accidental Death
0.01%
1/9333
0.00%
0/9291
General disorders
Alcohol Interaction
0.01%
1/9333
0.00%
0/9291
General disorders
Application Site Inflammation
0.01%
1/9333
0.00%
0/9291
General disorders
Discomfort
0.01%
1/9333
0.00%
0/9291
General disorders
Foaming At Mouth
0.01%
1/9333
0.00%
0/9291
General disorders
Gait Disturbance
0.00%
0/9333
0.01%
1/9291
General disorders
Generalised Oedema
0.01%
1/9333
0.00%
0/9291
General disorders
Hernia
0.01%
1/9333
0.00%
0/9291
General disorders
Hypothermia
0.01%
1/9333
0.00%
0/9291
General disorders
Inflammation
0.00%
0/9333
0.01%
1/9291
General disorders
Injection Site Swelling
0.01%
1/9333
0.00%
0/9291
General disorders
Pain
0.00%
0/9333
0.01%
1/9291
General disorders
Pelvic Mass
0.00%
0/9333
0.01%
1/9291
General disorders
Ulcer Haemorrhage
0.01%
1/9333
0.01%
1/9291
General disorders
Unevaluable Event
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Cholecystitis
0.08%
7/9333
0.11%
10/9291
Hepatobiliary disorders
Cholelithiasis
0.10%
9/9333
0.10%
9/9291
Hepatobiliary disorders
Cholecystitis Acute
0.05%
5/9333
0.08%
7/9291
Hepatobiliary disorders
Hepatic Failure
0.02%
2/9333
0.04%
4/9291
Hepatobiliary disorders
Bile Duct Stone
0.02%
2/9333
0.02%
2/9291
Hepatobiliary disorders
Biliary Colic
0.01%
1/9333
0.02%
2/9291
Hepatobiliary disorders
Cholangitis
0.01%
1/9333
0.02%
2/9291
Hepatobiliary disorders
Hepatic Cirrhosis
0.01%
1/9333
0.02%
2/9291
Hepatobiliary disorders
Jaundice
0.00%
0/9333
0.02%
2/9291
Hepatobiliary disorders
Bile Duct Obstruction
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Cholecystitis Chronic
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Cholestasis
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Gallbladder Disorder
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Gallbladder Necrosis
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Hepatic Function Abnormal
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Hepatitis Toxic
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Hepatocellular Injury
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Ischaemic Hepatitis
0.01%
1/9333
0.00%
0/9291
Hepatobiliary disorders
Liver Disorder
0.01%
1/9333
0.00%
0/9291
Immune system disorders
Anaphylactic Reaction
0.00%
0/9333
0.03%
3/9291
Immune system disorders
Anaphylactic Shock
0.03%
3/9333
0.01%
1/9291
Immune system disorders
Drug Hypersensitivity
0.01%
1/9333
0.03%
3/9291
Immune system disorders
Hypersensitivity
0.01%
1/9333
0.02%
2/9291
Immune system disorders
Allergy To Arthropod Bite
0.00%
0/9333
0.01%
1/9291
Immune system disorders
Contrast Media Allergy
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Pneumonia
0.74%
69/9333
1.0%
95/9291
Infections and infestations
Sepsis
0.18%
17/9333
0.29%
27/9291
Infections and infestations
Urinary Tract Infection
0.27%
25/9333
0.20%
19/9291
Infections and infestations
Gastroenteritis
0.18%
17/9333
0.12%
11/9291
Infections and infestations
Bronchitis
0.14%
13/9333
0.16%
15/9291
Infections and infestations
Mediastinitis
0.12%
11/9333
0.04%
4/9291
Infections and infestations
Bronchopneumonia
0.11%
10/9333
0.04%
4/9291
Infections and infestations
Septic Shock
0.05%
5/9333
0.11%
10/9291
Infections and infestations
Cellulitis
0.10%
9/9333
0.10%
9/9291
Infections and infestations
Postoperative Wound Infection
0.10%
9/9333
0.03%
3/9291
Infections and infestations
Respiratory Tract Infection
0.10%
9/9333
0.05%
5/9291
Infections and infestations
Diverticulitis
0.08%
7/9333
0.09%
8/9291
Infections and infestations
Wound Infection
0.08%
7/9333
0.09%
8/9291
Infections and infestations
Appendicitis
0.06%
6/9333
0.02%
2/9291
Infections and infestations
Infection
0.01%
1/9333
0.05%
5/9291
Infections and infestations
Lung Infection
0.05%
5/9333
0.04%
4/9291
Infections and infestations
Erysipelas
0.04%
4/9333
0.04%
4/9291
Infections and infestations
Lower Respiratory Tract Infection
0.03%
3/9333
0.04%
4/9291
Infections and infestations
Urosepsis
0.04%
4/9333
0.02%
2/9291
Infections and infestations
Cystitis
0.03%
3/9333
0.02%
2/9291
Infections and infestations
Endocarditis
0.03%
3/9333
0.02%
2/9291
Infections and infestations
Gangrene
0.02%
2/9333
0.03%
3/9291
Infections and infestations
Gastrointestinal Infection
0.03%
3/9333
0.01%
1/9291
Infections and infestations
Osteomyelitis
0.03%
3/9333
0.03%
3/9291
Infections and infestations
Pyelonephritis
0.03%
3/9333
0.02%
2/9291
Infections and infestations
Staphylococcal Sepsis
0.03%
3/9333
0.01%
1/9291
Infections and infestations
Upper Respiratory Tract Infection
0.03%
3/9333
0.03%
3/9291
Infections and infestations
Abscess Limb
0.02%
2/9333
0.00%
0/9291
Infections and infestations
Acute Tonsillitis
0.02%
2/9333
0.00%
0/9291
Infections and infestations
Anal Abscess
0.02%
2/9333
0.02%
2/9291
Infections and infestations
Bacteraemia
0.02%
2/9333
0.01%
1/9291
Infections and infestations
Gastroenteritis Caliciviral
0.02%
2/9333
0.00%
0/9291
Infections and infestations
Gastroenteritis Viral
0.02%
2/9333
0.00%
0/9291
Infections and infestations
Incision Site Infection
0.02%
2/9333
0.01%
1/9291
Infections and infestations
Lobar Pneumonia
0.00%
0/9333
0.02%
2/9291
Infections and infestations
Localised Infection
0.00%
0/9333
0.02%
2/9291
Infections and infestations
Sinusitis
0.02%
2/9333
0.00%
0/9291
Infections and infestations
Skin Infection
0.02%
2/9333
0.02%
2/9291
Infections and infestations
Staphylococcal Infection
0.02%
2/9333
0.00%
0/9291
Infections and infestations
Tooth Abscess
0.00%
0/9333
0.02%
2/9291
Infections and infestations
Abdominal Abscess
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Abdominal Wall Infection
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Abscess
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Acquired Immunodeficiency Syndrome
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Acute Sinusitis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Arthritis Bacterial
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Arthritis Infective
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Catheter Related Infection
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Catheter Site Infection
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Cholecystitis Infective
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Clostridium Difficile Colitis
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Dengue Fever
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Device Related Infection
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Diarrhoea Infectious
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Endometritis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Enterococcal Infection
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Enterocolitis Infectious
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Febrile Infection
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Gastric Infection
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Gastroenteritis Rotavirus
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Gastroenteritis Salmonella
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Groin Abscess
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Groin Infection
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Haematoma Infection
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Helicobacter Gastritis
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Hepatitis Viral
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Herpes Zoster
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Histoplasmosis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Impetigo
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Incision Site Abscess
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Infected Skin Ulcer
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Infective Exacerbation Of Chronic Obstructive Airways Disease
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Infective Tenosynovitis
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Inguinal Hernia Gangrenous
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Injection Site Cellulitis
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Intervertebral Discitis
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Laryngitis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Liver Abscess
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Lyme Disease
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Meningitis
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Necrotising Fasciitis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Pancreatic Abscess
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Perineal Abscess
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Pharyngitis
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Pneumococcal Sepsis
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Pneumonia Staphylococcal
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Post Procedural Cellulitis
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Post Procedural Infection
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Post Procedural Sepsis
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Pulmonary Sepsis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Pulmonary Tuberculosis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Puncture Site Abscess
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Puncture Site Infection
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Pyelonephritis Acute
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Pyothorax
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Rectal Abscess
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Renal Abscess
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Retroperitoneal Abscess
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Staphylococcal Mediastinitis
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Sternitis
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Subcutaneous Abscess
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Syphilis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Tooth Infection
0.00%
0/9333
0.01%
1/9291
Infections and infestations
Tracheitis
0.01%
1/9333
0.00%
0/9291
Infections and infestations
Tracheobronchitis
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Viral Myocarditis
0.01%
1/9333
0.01%
1/9291
Infections and infestations
Viral Pericarditis
0.00%
0/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Thrombosis In Device
0.38%
35/9333
0.61%
57/9291
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
0.60%
56/9333
0.51%
47/9291
Injury, poisoning and procedural complications
In-Stent Coronary Artery Restenosis
0.38%
35/9333
0.27%
25/9291
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
0.16%
15/9333
0.25%
23/9291
Injury, poisoning and procedural complications
In-Stent Arterial Restenosis
0.11%
10/9333
0.13%
12/9291
Injury, poisoning and procedural complications
Coronary Artery Restenosis
0.04%
4/9333
0.10%
9/9291
Injury, poisoning and procedural complications
Femur Fracture
0.03%
3/9333
0.08%
7/9291
Injury, poisoning and procedural complications
Post Procedural Haematoma
0.08%
7/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Fall
0.01%
1/9333
0.05%
5/9291
Injury, poisoning and procedural complications
Femoral Neck Fracture
0.03%
3/9333
0.05%
5/9291
Injury, poisoning and procedural complications
Postpericardiotomy Syndrome
0.05%
5/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Hip Fracture
0.04%
4/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Lower Limb Fracture
0.00%
0/9333
0.04%
4/9291
Injury, poisoning and procedural complications
Post Procedural Complication
0.04%
4/9333
0.04%
4/9291
Injury, poisoning and procedural complications
Subdural Haematoma
0.04%
4/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Wrist Fracture
0.04%
4/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Hand Fracture
0.03%
3/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Head Injury
0.01%
1/9333
0.03%
3/9291
Injury, poisoning and procedural complications
Injury
0.01%
1/9333
0.03%
3/9291
Injury, poisoning and procedural complications
Operative Haemorrhage
0.02%
2/9333
0.03%
3/9291
Injury, poisoning and procedural complications
Postoperative Thoracic Procedure Complication
0.03%
3/9333
0.03%
3/9291
Injury, poisoning and procedural complications
Postoperative Wound Complication
0.02%
2/9333
0.03%
3/9291
Injury, poisoning and procedural complications
Procedural Pain
0.03%
3/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Subcutaneous Haematoma
0.03%
3/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Wound Dehiscence
0.03%
3/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Alcohol Poisoning
0.02%
2/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Clavicle Fracture
0.00%
0/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Concussion
0.02%
2/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Facial Bones Fracture
0.02%
2/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Foot Fracture
0.00%
0/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Graft Thrombosis
0.00%
0/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Humerus Fracture
0.02%
2/9333
0.01%
1/9291
Injury, poisoning and procedural complications
Ligament Rupture
0.02%
2/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Limb Injury
0.02%
2/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Limb Traumatic Amputation
0.02%
2/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Overdose
0.02%
2/9333
0.00%
0/9291
Injury, poisoning and procedural complications
Postoperative Thrombosis
0.01%
1/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Procedural Hypotension
0.00%
0/9333
0.02%
2/9291
Injury, poisoning and procedural complications
Renal Injury
0.01%
1/9333
0.02%
2/9291
Nervous system disorders
Cerebral Atrophy
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Cerebral Disorder
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Neoplasm Malignant
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Cancer Metastatic
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Neoplasm
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour Of The Caecum
0.01%
1/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour Of The Duodenum
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Leukaemia
0.01%
1/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
0.01%
1/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
0.01%
1/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Cerebrovascular Insufficiency
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Neoplasm
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
0.01%
1/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma Of Liver
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal Adenocarcinoma
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip And/Or Oral Cavity Cancer
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis Carcinomatosa
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic Lymphoma
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lymph Nodes
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Prostate
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nipple Neoplasm
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Recurrent
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural Mesothelioma
0.01%
1/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia Vera
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
0.01%
1/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Recurrent
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Orthostatic Hypotension
0.04%
4/9333
0.03%
3/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
0.01%
1/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Metastatic
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer Metastatic
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal Neoplasm
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Metastatic
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Stage Unspecified
0.01%
1/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal Cord Neoplasm
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis Cancer
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer Metastatic
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Cerebrovascular Accident
0.80%
75/9333
0.54%
50/9291
Nervous system disorders
Syncope
0.34%
32/9333
0.32%
30/9291
Nervous system disorders
Ischaemic Stroke
0.21%
20/9333
0.30%
28/9291
Nervous system disorders
Transient Ischaemic Attack
0.20%
19/9333
0.25%
23/9291
Nervous system disorders
Dizziness
0.14%
13/9333
0.08%
7/9291
Nervous system disorders
Cerebral Haemorrhage
0.10%
9/9333
0.03%
3/9291
Nervous system disorders
Cerebral Infarction
0.08%
7/9333
0.09%
8/9291
Nervous system disorders
Presyncope
0.09%
8/9333
0.02%
2/9291
Nervous system disorders
Haemorrhagic Stroke
0.06%
6/9333
0.08%
7/9291
Nervous system disorders
Headache
0.06%
6/9333
0.03%
3/9291
Nervous system disorders
Haemorrhage Intracranial
0.05%
5/9333
0.02%
2/9291
Nervous system disorders
Paraesthesia
0.05%
5/9333
0.04%
4/9291
Nervous system disorders
Hemiparesis
0.04%
4/9333
0.02%
2/9291
Nervous system disorders
Loss Of Consciousness
0.04%
4/9333
0.02%
2/9291
Nervous system disorders
Parkinson's Disease
0.01%
1/9333
0.04%
4/9291
Nervous system disorders
Subarachnoid Haemorrhage
0.04%
4/9333
0.02%
2/9291
Nervous system disorders
Syncope Vasovagal
0.04%
4/9333
0.02%
2/9291
Nervous system disorders
Carotid Artery Stenosis
0.03%
3/9333
0.02%
2/9291
Nervous system disorders
Convulsion
0.03%
3/9333
0.03%
3/9291
Nervous system disorders
Depressed Level Of Consciousness
0.00%
0/9333
0.03%
3/9291
Nervous system disorders
Hypoaesthesia
0.02%
2/9333
0.03%
3/9291
Nervous system disorders
Hypotonia
0.03%
3/9333
0.00%
0/9291
Nervous system disorders
Migraine
0.03%
3/9333
0.01%
1/9291
Nervous system disorders
Altered State Of Consciousness
0.00%
0/9333
0.02%
2/9291
Nervous system disorders
Brain Stem Ischaemia
0.00%
0/9333
0.02%
2/9291
Nervous system disorders
Cerebral Ischaemia
0.02%
2/9333
0.01%
1/9291
Nervous system disorders
Cerebrovascular Disorder
0.00%
0/9333
0.02%
2/9291
Nervous system disorders
Dementia
0.00%
0/9333
0.02%
2/9291
Nervous system disorders
Encephalopathy
0.02%
2/9333
0.01%
1/9291
Nervous system disorders
Hypoxic Encephalopathy
0.00%
0/9333
0.02%
2/9291
Nervous system disorders
Neuralgia
0.02%
2/9333
0.00%
0/9291
Nervous system disorders
Partial Seizures
0.02%
2/9333
0.00%
0/9291
Nervous system disorders
Balance Disorder
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Brain Oedema
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Brain Stem Infarction
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Brain Stem Stroke
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Carotid Artery Disease
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Carotid Artery Occlusion
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Carotid Artery Thrombosis
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Carotid Sinus Syndrome
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Cervicobrachial Syndrome
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Cognitive Disorder
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Complex Partial Seizures
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Diabetic Hyperosmolar Coma
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Diabetic Neuropathy
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Dysphasia
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Embolic Cerebral Infarction
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Encephalitis
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Epilepsy
0.01%
1/9333
0.01%
1/9291
Nervous system disorders
Extrapyramidal Disorder
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Facial Paresis
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Febrile Convulsion
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Haemorrhagic Cerebral Infarction
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Hepatic Encephalopathy
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Intracranial Haematoma
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Ischaemic Cerebral Infarction
0.01%
1/9333
0.01%
1/9291
Nervous system disorders
Lacunar Infarction
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Lumbar Radiculopathy
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Mental Impairment
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Myelitis Transverse
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Narcolepsy
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Parkinsonism
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Phrenic Nerve Paralysis
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Post Herpetic Neuralgia
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Progressive Supranuclear Palsy
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Psychomotor Hyperactivity
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Sciatica
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Speech Disorder
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Spinal Cord Compression
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Spinal Cord Disorder
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Thalamus Haemorrhage
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Thrombotic Stroke
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Vascular Encephalopathy
0.01%
1/9333
0.00%
0/9291
Nervous system disorders
Vertebrobasilar Insufficiency
0.01%
1/9333
0.01%
1/9291
Nervous system disorders
Vith Nerve Paralysis
0.00%
0/9333
0.01%
1/9291
Nervous system disorders
Vocal Cord Paresis
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Anxiety
0.10%
9/9333
0.06%
6/9291
Psychiatric disorders
Depression
0.10%
9/9333
0.08%
7/9291
Psychiatric disorders
Confusional State
0.04%
4/9333
0.02%
2/9291
Psychiatric disorders
Suicide Attempt
0.01%
1/9333
0.02%
2/9291
Psychiatric disorders
Acute Stress Disorder
0.01%
1/9333
0.01%
1/9291
Psychiatric disorders
Agitation
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Alcohol Abuse
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Alcoholism
0.00%
0/9333
0.01%
1/9291
Psychiatric disorders
Anxiety Disorder
0.01%
1/9333
0.01%
1/9291
Psychiatric disorders
Completed Suicide
0.01%
1/9333
0.01%
1/9291
Psychiatric disorders
Delirium
0.01%
1/9333
0.01%
1/9291
Psychiatric disorders
Drug Abuse
0.00%
0/9333
0.01%
1/9291
Psychiatric disorders
Insomnia
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Mania
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Mental Disorder
0.00%
0/9333
0.01%
1/9291
Psychiatric disorders
Nervousness
0.00%
0/9333
0.01%
1/9291
Psychiatric disorders
Neurosis
0.00%
0/9333
0.01%
1/9291
Psychiatric disorders
Panic Attack
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Post-Traumatic Amnestic Disorder
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Psychotic Disorder
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Schizophrenia, Paranoid Type
0.00%
0/9333
0.01%
1/9291
Psychiatric disorders
Sleep Disorder
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Suicidal Ideation
0.01%
1/9333
0.01%
1/9291
Psychiatric disorders
Tension
0.01%
1/9333
0.00%
0/9291
Psychiatric disorders
Transient Psychosis
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Renal Failure Acute
0.36%
34/9333
0.27%
25/9291
Renal and urinary disorders
Renal Failure
0.27%
25/9333
0.26%
24/9291
Renal and urinary disorders
Haematuria
0.16%
15/9333
0.11%
10/9291
Renal and urinary disorders
Renal Failure Chronic
0.08%
7/9333
0.08%
7/9291
Renal and urinary disorders
Urinary Retention
0.03%
3/9333
0.08%
7/9291
Renal and urinary disorders
Renal Impairment
0.05%
5/9333
0.04%
4/9291
Renal and urinary disorders
Calculus Ureteric
0.02%
2/9333
0.04%
4/9291
Renal and urinary disorders
Calculus Urinary
0.00%
0/9333
0.03%
3/9291
Renal and urinary disorders
Haemorrhage Urinary Tract
0.03%
3/9333
0.01%
1/9291
Renal and urinary disorders
Nephrolithiasis
0.03%
3/9333
0.03%
3/9291
Renal and urinary disorders
Nephropathy Toxic
0.03%
3/9333
0.02%
2/9291
Renal and urinary disorders
Renal Artery Stenosis
0.02%
2/9333
0.03%
3/9291
Renal and urinary disorders
Renal Colic
0.03%
3/9333
0.01%
1/9291
Renal and urinary disorders
Azotaemia
0.02%
2/9333
0.01%
1/9291
Renal and urinary disorders
Urinary Bladder Haemorrhage
0.02%
2/9333
0.00%
0/9291
Renal and urinary disorders
Urinary Bladder Polyp
0.00%
0/9333
0.02%
2/9291
Renal and urinary disorders
Anuria
0.01%
1/9333
0.01%
1/9291
Renal and urinary disorders
Bladder Mass
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Bladder Prolapse
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Bladder Tamponade
0.01%
1/9333
0.01%
1/9291
Renal and urinary disorders
Calculus Bladder
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Calculus Urethral
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Cystitis Haemorrhagic
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Cystitis Noninfective
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Dysuria
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Glomerulonephritis
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Glomerulonephritis Membranous
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Glomerulonephritis Minimal Lesion
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Hydronephrosis
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Nephritis Autoimmune
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Nephrotic Syndrome
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Obstructive Uropathy
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Oliguria
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Renal Artery Thrombosis
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Renal Disorder
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Renal Haemorrhage
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Renal Mass
0.01%
1/9333
0.01%
1/9291
Renal and urinary disorders
Urethral Haemorrhage
0.01%
1/9333
0.00%
0/9291
Renal and urinary disorders
Urinary Incontinence
0.00%
0/9333
0.01%
1/9291
Renal and urinary disorders
Urinary Tract Obstruction
0.00%
0/9333
0.01%
1/9291
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
0.05%
5/9333
0.03%
3/9291
Reproductive system and breast disorders
Epididymitis
0.03%
3/9333
0.01%
1/9291
Reproductive system and breast disorders
Prostatitis
0.01%
1/9333
0.02%
2/9291
Reproductive system and breast disorders
Balanitis
0.00%
0/9333
0.01%
1/9291
Reproductive system and breast disorders
Cervical Dysplasia
0.01%
1/9333
0.00%
0/9291
Reproductive system and breast disorders
Menometrorrhagia
0.00%
0/9333
0.01%
1/9291
Reproductive system and breast disorders
Ovarian Cyst
0.00%
0/9333
0.01%
1/9291
Reproductive system and breast disorders
Prostatic Haemorrhage
0.01%
1/9333
0.01%
1/9291
Reproductive system and breast disorders
Prostatism
0.01%
1/9333
0.00%
0/9291
Reproductive system and breast disorders
Spermatocele
0.00%
0/9333
0.01%
1/9291
Reproductive system and breast disorders
Uterine Haemorrhage
0.01%
1/9333
0.00%
0/9291
Reproductive system and breast disorders
Vaginal Haemorrhage
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.80%
75/9333
0.54%
50/9291
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
0.35%
33/9333
0.57%
53/9291
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
0.21%
20/9333
0.34%
32/9291
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
0.33%
31/9333
0.22%
20/9291
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
0.24%
22/9333
0.18%
17/9291
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.23%
21/9333
0.20%
19/9291
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.17%
16/9333
0.17%
16/9291
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.16%
15/9333
0.10%
9/9291
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.03%
3/9333
0.10%
9/9291
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.08%
7/9333
0.09%
8/9291
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
0.05%
5/9333
0.06%
6/9291
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
0.03%
3/9333
0.06%
6/9291
Respiratory, thoracic and mediastinal disorders
Asthma
0.05%
5/9333
0.03%
3/9291
Respiratory, thoracic and mediastinal disorders
Hydrothorax
0.02%
2/9333
0.05%
5/9291
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
0.05%
5/9333
0.03%
3/9291
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
0.04%
4/9333
0.03%
3/9291
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/9333
0.03%
3/9291
Respiratory, thoracic and mediastinal disorders
Cough
0.03%
3/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
0.03%
3/9333
0.02%
2/9291
Respiratory, thoracic and mediastinal disorders
Haemothorax
0.00%
0/9333
0.03%
3/9291
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
0.00%
0/9333
0.03%
3/9291
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.03%
3/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
0.03%
3/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
0.02%
2/9333
0.03%
3/9291
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.02%
2/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Hyperventilation
0.02%
2/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Lung Disorder
0.02%
2/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.02%
2/9333
0.02%
2/9291
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
0.01%
1/9333
0.02%
2/9291
Respiratory, thoracic and mediastinal disorders
Alveolitis Fibrosing
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Apnoea
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Brain Hypoxia
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Bronchial Haemorrhage
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Dyspnoea Paroxysmal Nocturnal
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Emphysema
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Laryngeal Leukoplakia
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
0.01%
1/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Laryngeal Stenosis
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Laryngospasm
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Inflammation
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Lung Consolidation
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Mediastinal Haematoma
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Mediastinal Haemorrhage
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Nasal Polyps
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Nocturnal Dyspnoea
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Pulmonary Alveolar Haemorrhage
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Pulmonary Haematoma
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Haemorrhage
0.01%
1/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Systemic Sclerosis Pulmonary
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Tachypnoea
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Thoracic Haemorrhage
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Tonsillar Disorder
0.01%
1/9333
0.00%
0/9291
Respiratory, thoracic and mediastinal disorders
Tracheal Stenosis
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Vocal Cord Polyp
0.01%
1/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Wegener's Granulomatosis
0.00%
0/9333
0.01%
1/9291
Respiratory, thoracic and mediastinal disorders
Wheezing
0.01%
1/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Dermatitis Allergic
0.01%
1/9333
0.06%
6/9291
Skin and subcutaneous tissue disorders
Angioedema
0.03%
3/9333
0.04%
4/9291
Skin and subcutaneous tissue disorders
Rash
0.04%
4/9333
0.03%
3/9291
Skin and subcutaneous tissue disorders
Urticaria
0.03%
3/9333
0.04%
4/9291
Skin and subcutaneous tissue disorders
Pruritus
0.01%
1/9333
0.03%
3/9291
Skin and subcutaneous tissue disorders
Skin Ulcer
0.03%
3/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Decubitus Ulcer
0.02%
2/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.02%
2/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Skin Necrosis
0.02%
2/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Blister
0.00%
0/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Dermatitis
0.01%
1/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Dermatomyositis
0.01%
1/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Dry Gangrene
0.01%
1/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Eczema Nummular
0.00%
0/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Hypoaesthesia Facial
0.00%
0/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Increased Tendency To Bruise
0.01%
1/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Leukocytoclastic Vasculitis
0.00%
0/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Pruritus Generalised
0.01%
1/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Rash Erythematous
0.01%
1/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Rash Generalised
0.01%
1/9333
0.00%
0/9291
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
0.00%
0/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Skin Inflammation
0.01%
1/9333
0.00%
0/9291
Surgical and medical procedures
Cardiac Pacemaker Insertion
0.01%
1/9333
0.00%
0/9291
Surgical and medical procedures
Coronary Artery Bypass
0.01%
1/9333
0.01%
1/9291
Surgical and medical procedures
Implantable Defibrillator Insertion
0.00%
0/9333
0.01%
1/9291
Surgical and medical procedures
Leg Amputation
0.01%
1/9333
0.00%
0/9291
Surgical and medical procedures
Thoracic Cavity Drainage
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Hypertension
0.18%
17/9333
0.26%
24/9291
Vascular disorders
Hypotension
0.19%
18/9333
0.23%
21/9291
Vascular disorders
Hypertensive Crisis
0.08%
7/9333
0.13%
12/9291
Vascular disorders
Peripheral Ischaemia
0.11%
10/9333
0.08%
7/9291
Vascular disorders
Haematoma
0.03%
3/9333
0.09%
8/9291
Vascular disorders
Aortic Aneurysm
0.00%
0/9333
0.08%
7/9291
Vascular disorders
Shock
0.08%
7/9333
0.03%
3/9291
Vascular disorders
Deep Vein Thrombosis
0.06%
6/9333
0.06%
6/9291
Vascular disorders
Intermittent Claudication
0.06%
6/9333
0.06%
6/9291
Vascular disorders
Accelerated Hypertension
0.01%
1/9333
0.05%
5/9291
Vascular disorders
Arterial Thrombosis Limb
0.05%
5/9333
0.04%
4/9291
Vascular disorders
Peripheral Arterial Occlusive Disease
0.04%
4/9333
0.05%
5/9291
Vascular disorders
Peripheral Vascular Disorder
0.05%
5/9333
0.03%
3/9291
Vascular disorders
Aortic Dissection
0.02%
2/9333
0.04%
4/9291
Vascular disorders
Arterial Thrombosis
0.01%
1/9333
0.04%
4/9291
Vascular disorders
Circulatory Collapse
0.04%
4/9333
0.00%
0/9291
Vascular disorders
Aortic Stenosis
0.00%
0/9333
0.03%
3/9291
Vascular disorders
Arteriosclerosis
0.03%
3/9333
0.03%
3/9291
Vascular disorders
Femoral Artery Aneurysm
0.01%
1/9333
0.03%
3/9291
Vascular disorders
Haemorrhage
0.02%
2/9333
0.03%
3/9291
Vascular disorders
Hypertensive Emergency
0.03%
3/9333
0.03%
3/9291
Vascular disorders
Hypovolaemic Shock
0.03%
3/9333
0.02%
2/9291
Vascular disorders
Thrombophlebitis
0.02%
2/9333
0.03%
3/9291
Vascular disorders
Venous Thrombosis
0.02%
2/9333
0.03%
3/9291
Vascular disorders
Aortic Aneurysm Rupture
0.02%
2/9333
0.01%
1/9291
Vascular disorders
Arterial Occlusive Disease
0.02%
2/9333
0.02%
2/9291
Vascular disorders
Arteriosclerosis Obliterans
0.01%
1/9333
0.02%
2/9291
Vascular disorders
Arteriovenous Fistula
0.02%
2/9333
0.01%
1/9291
Vascular disorders
Artery Dissection
0.02%
2/9333
0.00%
0/9291
Vascular disorders
Cardiovascular Insufficiency
0.02%
2/9333
0.01%
1/9291
Vascular disorders
Femoral Artery Occlusion
0.02%
2/9333
0.02%
2/9291
Vascular disorders
Iliac Artery Stenosis
0.01%
1/9333
0.02%
2/9291
Vascular disorders
Leriche Syndrome
0.02%
2/9333
0.01%
1/9291
Vascular disorders
Shock Haemorrhagic
0.02%
2/9333
0.00%
0/9291
Vascular disorders
Thrombophlebitis Superficial
0.02%
2/9333
0.01%
1/9291
Vascular disorders
Thrombosis
0.02%
2/9333
0.00%
0/9291
Vascular disorders
Venous Thrombosis Limb
0.00%
0/9333
0.02%
2/9291
Vascular disorders
Aneurysm
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Aneurysm Ruptured
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Angiodysplasia
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Aortic Dilatation
0.01%
1/9333
0.01%
1/9291
Vascular disorders
Arterial Disorder
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Arterial Rupture
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Arteritis
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Bleeding Varicose Vein
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Blood Pressure Inadequately Controlled
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Embolism
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Embolism Venous
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Extremity Necrosis
0.01%
1/9333
0.01%
1/9291
Vascular disorders
Femoral Arterial Stenosis
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Haemodynamic Instability
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Iliac Artery Occlusion
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Iliac Artery Thrombosis
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Peripheral Artery Aneurysm
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Peripheral Artery Dissection
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Peripheral Embolism
0.01%
1/9333
0.01%
1/9291
Vascular disorders
Phlebitis
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Reperfusion Injury
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Subclavian Artery Stenosis
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Subclavian Artery Thrombosis
0.00%
0/9333
0.01%
1/9291
Vascular disorders
Subclavian Vein Thrombosis
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Vascular Occlusion
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Vasculitis
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Vena Cava Thrombosis
0.01%
1/9333
0.00%
0/9291
Vascular disorders
Venous Insufficiency
0.00%
0/9333
0.01%
1/9291
Skin and subcutaneous tissue disorders
Wound Haemorrhage
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
0.11%
10/9333
0.03%
3/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
0.06%
6/9333
0.11%
10/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
0.03%
3/9333
0.10%
9/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
0.06%
6/9333
0.09%
8/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
0.08%
7/9333
0.05%
5/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
0.02%
2/9333
0.06%
6/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
0.01%
1/9333
0.05%
5/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
0.05%
5/9333
0.03%
3/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
0.00%
0/9333
0.03%
3/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
0.01%
1/9333
0.03%
3/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
0.01%
1/9333
0.03%
3/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
0.03%
3/9333
0.03%
3/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
0.00%
0/9333
0.03%
3/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
0.03%
3/9333
0.02%
2/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
0.02%
2/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
0.02%
2/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Neoplasm
0.02%
2/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer Metastatic
0.02%
2/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
0.00%
0/9333
0.02%
2/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
0.02%
2/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
0.02%
2/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
0.01%
1/9333
0.02%
2/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Bone
0.01%
1/9333
0.02%
2/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
0.00%
0/9333
0.02%
2/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
0.02%
2/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
0.00%
0/9333
0.02%
2/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
0.02%
2/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
0.02%
2/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal Neoplasm
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Duodenal Neoplasm
0.01%
1/9333
0.00%
0/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm Of Skin
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Uterine Neoplasm
0.00%
0/9333
0.01%
1/9291
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer Recurrent
0.00%
0/9333
0.01%
1/9291

Other adverse events

Other adverse events
Measure
TICAGRELOR
Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL
Clopidogrel 75 mg once daily dose (ODD)
Nervous system disorders
Headache
6.7%
621/9333
6.1%
565/9291
Respiratory, thoracic and mediastinal disorders
Dyspnoea
11.9%
1106/9333
6.7%
623/9291
Respiratory, thoracic and mediastinal disorders
Epistaxis
6.1%
566/9333
3.4%
317/9291
Respiratory, thoracic and mediastinal disorders
Cough
5.3%
490/9333
5.0%
467/9291

Additional Information

Gerard Lynch

AstraZeneca

Results disclosure agreements

  • Principal investigator is a sponsor employee An Investigator agrees to provide a copy of the publication to AstraZeneca (AZ) for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites.
  • Publication restrictions are in place

Restriction type: OTHER