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: 2025-12-25 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT02539160
Description: None
Frequency Threshold: 5
Time Frame: Any adverse event during the study period (any time from enrollment until completion of the study, up to 20 days) was recorded.
Study: NCT02539160
Study Brief: Impact of Chronic Kidney Disease on the Effects of Ticagrelor in Patients With Diabetes and 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
CKD - Ticagrelor 90 Patients with chronic kidney disease will receive ticagrelor 90mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 60mg twice/daily for 7-10 days. 0 None 1 38 9 38 View
CKD - Ticagrelor 60 Patients with chronic kidney disease will receive ticagrelor 60mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 90mg twice/daily for 7-10 days. 0 None 1 38 6 38 View
Non-CKD - Ticagrelor 90 Patients without chronic kidney disease will receive ticagrelor 90mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 60mg twice/daily for 7-10 days. 0 None 0 39 9 39 View
Non-CKD - Ticagrelor 60 Patients without chronic kidney disease will receive ticagrelor 60mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 90mg twice/daily for 7-10 days. 0 None 1 39 7 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hypokalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
minor bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View