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 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:01 AM
NCT ID: NCT02691494
Description: Treatment-emergent adverse events are presented.
Frequency Threshold: 5
Time Frame: From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 160.3 (51.75), 155.2 (65.19), and 158.7 (54.68) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively
Study: NCT02691494
Study Brief: Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
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 Placebo for both elagolix BID and E2/NETA QD 0 None 1 94 34 94 View
Elagolix Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD 0 None 4 95 58 95 View
Elagolix + E2-NETA Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD 0 None 7 189 80 189 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
OBESITY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
ABORTION COMPLETE SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 21.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
DYSFUNCTIONAL UTERINE BLEEDING SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
DYSMENORRHOEA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
MENORRHAGIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
PELVIC PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
HYPERTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
LIBIDO DECREASED SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
MOOD SWINGS SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
DYSMENORRHOEA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View