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 @ 2:00 PM
Ignite Modification Date: 2025-12-25 @ 12:45 PM
NCT ID: NCT00927095
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00927095
Study Brief: Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Continuous Low Dose Oral Contraceptive continuous low dose oral contraceptive low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months None None 0 22 22 22 View
Interrupted Low Dose Oral Contraceptive (21/7 Platform) interrupted low dose oral contraceptive (21/7 platform) 20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month None None 0 21 21 21 View
Continuous Placebo continuous placebo placebo: daily None None 0 24 24 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Breast Tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Low Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Headache, Not Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
GI Symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Leg or Calf Discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anxious Symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Spotting SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Changing Bleeding Pattern - Prolonged Bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Headache, Migraine, No Aura SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shortness of Breath or Chest Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Change in Bleeding Pattern SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Suicidality SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Yeast Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heartburn or Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache, Migraine, with Aura SYSTEMATIC_ASSESSMENT Nervous system disorders None View