Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:47 PM
Ignite Modification Date: 2025-12-25 @ 3:14 PM
NCT ID: NCT05889468
Description: Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.
Frequency Threshold: 0
Time Frame: 4-6 weeks postpartum
Study: NCT05889468
Study Brief: Postpartum ASA and NT-proBNP
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Group The treatment group will be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission. Patients will be scheduled for a 4-6 week postpartum clinic appointment, which is standard for these patients outside of this proposal. Aspirin 81Mg Ec Tab: Participant may be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission. 0 None 5 55 2 55 View
Placebo Group The control group will receive a 6-week supply of placebo medication from the Investigational Pharmacy prior to discharge. The placebo will be identically appearing to the 81 mg aspirin. Patients will be scheduled for a 4-6 week postpartum clinic appointment, which is standard for these patients outside of this proposal. Placebo: Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission. 0 None 6 55 5 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Unexpected hospitalization (preeclampsia or cardiovascular-related) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Unexpected hospitalization (bleeding related) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Unexpected hospitalization (infection or wound complication) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Postpartum triage visit SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View