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: 2025-12-25 @ 1:09 AM
Ignite Modification Date: 2025-12-25 @ 11:20 PM
NCT ID: NCT04964193
Description: \[Not Specified\]
Frequency Threshold: 0
Time Frame: at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing
Study: NCT04964193
Study Brief: Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Elzsa Film-coated Tablet New (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose. 0 None 0 24 6 24 View
Diane-35 Sugar-coated Tablet Marketed (reference) Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose. 0 None 0 24 9 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Breast tenderness or Breast discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Frequently Urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Syncope SYSTEMATIC_ASSESSMENT General disorders None View
Flu like symptoms (Runny rose nose, headache) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View