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: 2025-12-24 @ 6:25 PM
Ignite Modification Date: 2025-12-25 @ 3:55 PM
NCT ID: NCT00357968
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00357968
Study Brief: Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prasugrel Before Cross-over One time oral loading dose (LD) of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days. None None 8 102 40 102 View
Clopidogrel Before Cross-over One time oral loading dose of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days. None None 7 99 40 99 View
Prasugrel After Cross-over Prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose)once daily for 14 days after cross-over from one time loading dose of clopidogrel 600 mg and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days None None 1 55 16 55 View
Clopidogrel After Cross-over Clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days after cross-over from one time loading dose of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10 mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days. None None 3 53 12 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Borrelia infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Chronic obstructive pulmonmary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Post procedural myocardial infarction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VIth nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Incision site complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Coagulation time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Femoral artery aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Puncture site pain SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Syncope vasovagal SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arteriovenous fistula SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure orthostatic SYSTEMATIC_ASSESSMENT Investigations None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac enzymes increased SYSTEMATIC_ASSESSMENT Investigations None View
Catheter site discharge SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site haematoma SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Incision site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower respiratiry tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Middle insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Operative haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Wound secretion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View