Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:04 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT00619866
Description: None
Frequency Threshold: 5
Time Frame: From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Study: NCT00619866
Study Brief: An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis
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 Participants received elagolix 150 mg tablets once a day for 12 weeks. 0 None 0 52 18 52 View
Elagolix 150 mg Participants initially randomized to elagolix 150 mg received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks. Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks. 0 None 0 69 31 69 View
Elagolix 250 mg Participants initially randomized to elagolix 250 mg received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks. Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks. 0 None 1 72 33 72 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ABORTION SPONTANEOUS SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (6.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (6.1) View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (6.1) View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (6.1) View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (6.1) View
VAGINAL MYCOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (6.1) View
BLOOD CHOLESTEROL INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA (6.1) View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (6.1) View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (6.1) View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (6.1) View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (6.1) View
ACNE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (6.1) View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (6.1) View