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 @ 2:54 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT00293059
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00293059
Study Brief: Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matching placebo to be taken orally daily None None 2 66 21 66 View
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo None None 1 119 46 119 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Vaginitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Metrorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View