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 @ 4:49 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT01818518
Description: All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed in this observational study.
Frequency Threshold: 0
Time Frame: No adverse events were assessed from the beginning through the duration of the study. This is an observational study and therefore adverse events were not assessed.
Study: NCT01818518
Study Brief: Neonatal Outcome by Reason for Delivery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Preterm Labor Group who goes into labor prior to 32 weeks of gestation 0 None 0 0 0 0 View
Prelabor Rupture of Membranes Group who have prelabor rupture of membranes are those who break their bag of water prior to 32 weeks gestation in the absence of labor. 0 None 0 0 0 0 View
IUGR Diagnosis on Admission Group who have the diagnosis of intrauterine growth restriction on admission to the hospital. 0 None 0 0 0 0 View
Pre-Eclampsia Diagnosis on Admission Group who have the diagnosis of pre-eclampsia noted on admission to the hospital 0 None 0 0 0 0 View
Vaginal Bleeding Diagnosis on Admission Group who have the presence of vaginal bleeding noted at the time of admission to the hospital 0 None 0 0 0 0 View
Short Cervix Diagnosis on Admission Group who have the diagnosis of a short cervical length at the time of admission to the hospital 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):