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 @ 7:40 PM
Ignite Modification Date: 2025-12-25 @ 5:20 PM
NCT ID: NCT04033003
Description: clinicaltrials.gov definition
Frequency Threshold: 0
Time Frame: from time of enrollment until study completion (11-14 months post delivery)
Study: NCT04033003
Study Brief: Group Antenatal Care and Delivery Project
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group ANC Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. 2 None 2 877 0 877 View
Stand ANC Individual standard antenatal care delivered at health facilities in Ghana 3 None 3 884 0 884 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death not related to study protocol NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):