Adverse Events Module

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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: 2025-12-26 @ 10:43 PM
Ignite Modification Date: 2025-12-26 @ 10:43 PM
NCT ID: NCT01107912
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT01107912
Study Brief: Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
5 mg Prasugrel (Elderly) Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2. None None 0 73 20 73 View
10 mg Prasugrel (Elderly) Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3. None None 2 71 31 71 View
75 mg Clopidogrel (Elderly) Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3. None None 2 72 25 72 View
5 mg Prasugrel (Non-Elderly) Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3. None None 0 79 23 79 View
10 mg Prasugrel (Non-Elderly) Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2. None None 2 82 39 82 View
75 mg Clopidogrel (Non-Elderly) Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3. None None 0 79 23 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Small intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Haemorrhagic diathesis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Faeces discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Infusion site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Hepatic cyst SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Ear abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Periorbital haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Traumatic haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Bleeding time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood urea SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Cardiac enzymes increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Bladder neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Restless legs syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Bronchitis chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Cold sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Skin haemorrhage SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View