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: 2025-12-25 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:42 AM
NCT ID: NCT03961360
Description: None
Frequency Threshold: 0
Time Frame: From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum
Study: NCT03961360
Study Brief: Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
162 mg/Day Aspirin Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia 0 None 24 110 51 110 View
81 mg/Day Aspirin Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia 0 None 19 110 61 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Placenta Abruption SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Postpartum hemorrhage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Maternal blood transfusion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Fetal Heart Defect SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Kidney Malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Necrotizing Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Preeclampsia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Gestational hypertension SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View