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 @ 2:53 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT04484259
Description: These adverse event reporting reflects adverse events occurred during the randomized phase of the study.
Frequency Threshold: 5
Time Frame: 10 days
Study: NCT04484259
Study Brief: Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ticagrelor 90 mg Monotherapy discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days 0 None 0 82 0 82 View
Ticagrelor ticagrelor 60 mg bid monotherapy Ticagrelor monotherapy: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days. 0 None 0 26 7 26 View
Aspirin Plus Clopidogrel aspirin 81 mg qd plus clopidogrel 75 mg qd Clopidogrel with aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days. 0 None 0 27 12 27 View
Aspirin Plus Ticagrelor aspirin 81 mg qd plus ticagrelor 60 mg bid Ticagrelor plus aspirin: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days. 0 None 0 28 7 28 View
Aspirin Plus Ticagrelor 90 mg 7-10 day run-in phase with aspirin 81 mg qd plus ticagrelor 90 mg bid 0 None 2 101 7 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
iliac artery perforation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View