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 @ 7:34 PM
Ignite Modification Date: 2025-12-25 @ 5:15 PM
NCT ID: NCT01963403
Description: Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.
Frequency Threshold: 5
Time Frame: Up to 84 days on either medication or placebo.
Study: NCT01963403
Study Brief: Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EE 30mcg/LNG 150mcg Combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days) 0 None 0 12 6 12 View
Placebo Placebo: 1 pill per day; daily during study participation (up to 84 days) 0 None 0 12 8 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea/vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cramping NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mood change NON_SYSTEMATIC_ASSESSMENT General disorders None View