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 @ 10:45 PM
Ignite Modification Date: 2025-12-25 @ 8:15 PM
NCT ID: NCT00356135
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00356135
Study Brief: Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prasgurel 10/10 mg Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. None None 3 47 16 47 View
Clopidogrel 75/75 mg Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. None None 0 48 25 48 View
Prasugrel 60/10 mg Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. None None 0 44 11 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
In-stent coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Faeces hard SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Exercise tolerance decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Feeling jittery SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Vessel puncture site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Neck injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Nicotine dependence SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dyshidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Increased tendency to bruise SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiac flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View