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: 2025-12-24 @ 7:57 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT03913104
Description: Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
Frequency Threshold: 0
Time Frame: Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Study: NCT03913104
Study Brief: Mail Order Mifepristone 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
Medication Abortion Patients Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit. 0 None 3 510 21 510 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemorrhage requiring blood transfusion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders FDA View
Hospitalization SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders FDA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders FDA View
Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders FDA View
Nausea/vomiting SYSTEMATIC_ASSESSMENT General disorders FDA View
Infection SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders FDA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders FDA View
Incomplete abortion SYSTEMATIC_ASSESSMENT Surgical and medical procedures FDA View
Dehydration SYSTEMATIC_ASSESSMENT General disorders FDA View
Vaginitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders FDA View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders FDA View