Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
NCT ID:
NCT00684203
Description:
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
Frequency Threshold:
5
Time Frame:
Up to Day 121
Study:
NCT00684203
Study Brief:
Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Vorapaxar 20 mg/1 mg | Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | None | None | 5 | 25 | 25 | 25 | View |
| Vorapaxar 20 mg/2.5 mg | Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | None | None | 4 | 24 | 23 | 24 | View |
| Vorapaxar 40 mg/1 mg | Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | None | None | 2 | 22 | 22 | 22 | View |
| Vorapaxar 40 mg/2.5 mg | Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | None | None | 2 | 26 | 23 | 26 | View |
| Placebo/Placebo | Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days). | None | None | 5 | 23 | 22 | 23 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Cardiac Tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Supraventricular Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Ventricle Rupture | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Ventricular Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Sudden Hearing Loss | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 10.1 | View |
| Inguinal Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Malaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Post Procedural Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Post Procedural Haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Rib Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Blood Glucose Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Rheumatoid Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Colon Adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Colon Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Loss of Consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Subarachnoid Haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Arteriosclerosis Obliterans | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Ventricular Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Abdominal Distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Gingival Bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Puncture Site Haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Puncture Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Venipuncture Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Hepatic Function Abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| Gingival Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Post Procedural Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Post Procedural Haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Blood Creatine Phosphokinase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Blood Pressure Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Blood Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Blood Triglycerides Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Blood Urine Present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Gamma-Glutamyltransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Haemoglobin Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Occult Blood | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Occult Blood Positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Protein Urine Present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| White Blood Cell Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Hyperchlesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Dizziness Postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Cold Sweat | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Drug Eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Haemorrhage Subcutaneous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Purpura | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Rash Erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Angiopathy | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |