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 @ 11:42 PM
Ignite Modification Date: 2025-12-25 @ 9:34 PM
NCT ID: NCT01587651
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01587651
Study Brief: Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects 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
Prasugrel Maintenance Dose Prasugrel 10 mg QD MD Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet None None 0 41 10 41 View
Ticagrelor Maintenance Dose Ticagrelor 90 mg twice-daily (BID) MD Ticagrelor Maintenance Dose : one 90mg film coated tablet None None 1 35 12 35 View
Prasugrel Loading Dose Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD) Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets None None 0 34 8 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
congestive heart failure None Cardiac disorders None View
depression None Nervous system disorders None View
pneumonia None Respiratory, thoracic and mediastinal disorders None View
alcohol poisoning None Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
angina pectoris None Cardiac disorders None View
injection site haematoma None General disorders None View
vision blurred None Eye disorders None View
allergic oedema None Immune system disorders None View
nasopharyngitis None Infections and infestations None View
renal failure None Renal and urinary disorders None View
diarrhoea None Gastrointestinal disorders None View
eccymosis None Skin and subcutaneous tissue disorders None View
headache None Nervous system disorders None View
upper respiratory tract infection None Infections and infestations None View
dyspnoea None Respiratory, thoracic and mediastinal disorders None View
periodontal disease None Gastrointestinal disorders None View
arthralgia None Musculoskeletal and connective tissue disorders None View
costochondritis None Musculoskeletal and connective tissue disorders None View
pain in extremity None Musculoskeletal and connective tissue disorders None View
alanine aminotransferase increased None Investigations None View
hypomagnesaemia None Metabolism and nutrition disorders None View
laceration None Injury, poisoning and procedural complications None View
muscle strain None Injury, poisoning and procedural complications None View
epistaxis None Respiratory, thoracic and mediastinal disorders None View