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 @ 3:24 AM
Ignite Modification Date: 2025-12-26 @ 2:03 AM
NCT ID: NCT03188705
Description: Adverse event data were collected during both intervention periods and for 30 days after the final study visit.
Frequency Threshold: 0
Time Frame: 37 days
Study: NCT03188705
Study Brief: CES1 Carriers in the PAPI Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Clopidogrel Alone Treatment All participants will receive clopidogrel treatment alone (300 mg loading dose followed by 75 mg/d for 6 days), followed by clopidogrel (75 mg) plus aspirin (324 mg) treatment on day 8. Clopidogrel: Participants will receive 300 mg of clopidogrel on the first day, then 75 mg per day for the next 6 days. Measures of pharmacodynamics will be assessed pre- and post-drug administration. Aspirin: Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration. 0 None 0 5 0 5 View
Clopidogrel and Aspirin Treatment All participants will receive clopidogrel treatment alone (300 mg loading dose followed by 75 mg/d for 6 days), followed by clopidogrel (75 mg) plus aspirin (324 mg) treatment on day 8. Clopidogrel: Participants will receive 300 mg of clopidogrel on the first day, then 75 mg per day for the next 6 days. Measures of pharmacodynamics will be assessed pre- and post-drug administration. Aspirin: Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration. 0 None 0 5 0 5 View
Serious Events(If Any):
Other Events(If Any):