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 @ 11:39 PM
Ignite Modification Date: 2025-12-25 @ 9:29 PM
NCT ID: NCT00474851
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
Study: NCT00474851
Study Brief: The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
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 Group Placebo group Placebo: Placebo capsule 1 pill PO daily Norethindrone acetate: Norethindrone acetate 5 mg PO daily None None 5 26 13 26 View
Intervention Group Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily Norethindrone acetate: Norethindrone acetate 5 mg PO daily None None 8 25 15 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization for pelvic/abdominal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Rectal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgias/arthralgias NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Mood swings NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View