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 @ 3:03 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT00001259
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT00001259
Study Brief: A Treatment Study for Premenstrual Syndrome (PMS)
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 8 weeks of placebo (P) injections (one injection per month) 0 None 0 10 0 10 View
GnRH Agonist Injections (Lupron-L Only) Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly before randomization to estradiol or progesterone arm in the crossover phase of the study 0 None 0 58 2 58 View
Estradiol 4 weeks of transdermal Estradiol (100mcg/day by skin patch) 0 None 0 48 3 48 View
Progesterone 5 weeks of Progesterone suppositories (200mg vaginally twice/day) 0 None 0 48 0 48 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mood disorder due to a general medical condition SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Genital atrophy SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View