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 @ 7:49 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT02756403
Description: Patients involved in study were called on telephone at one week to assess for any adverse events.
Frequency Threshold: 0
Time Frame: One week
Study: NCT02756403
Study Brief: A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Patients receiving Placebo preprocedure 0 None 0 45 0 45 View
Metronidazole Patients receivingMetronidazole for preprocedure antibiotic 0 None 1 41 0 41 View
Azithromycin Patients receiving Azithromycin for preprocedure antibiotic 0 None 0 46 0 46 View
Doxycycline Patients receiving Doxycycline for preprocedure antibiotic 0 None 0 42 0 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inpatient Hospitalization SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):