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 @ 7:55 PM
Ignite Modification Date: 2025-12-25 @ 5:30 PM
NCT ID: NCT00205504
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00205504
Study Brief: Oral Contraceptives in the Metabolic Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lean Women Women with Body Mass Index)BMI \<25 kg/m² None None 0 15 2 15 View
Obese Women Women with Body Mass Index (BMI) \>30 kg/m². Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use. None None 1 21 2 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gallstones removal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tiredness NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain with venipuncture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Phlebitis due to catheter insertion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dizziness due to Ortho Tricyclen NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View