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 @ 7:52 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT02689804
Description: The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT02689804
Study Brief: EC PK in Women With Normal and Obese BMI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Normal-BMI on LNG Women with normal BMI will receive LNG-EC 0 None 0 8 4 8 View
Normal-BMI on UPA Women with obese BMI will receive UPA-EC 0 None 0 8 3 8 View
Obese-BMI on LNG Women with obese BMI will receive LNG-EC 0 None 0 8 4 8 View
Obese-BMI on UPA Women with obese BMI will receive UPA-EC 0 None 0 8 2 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View