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 @ 2:14 PM
Ignite Modification Date: 2025-12-25 @ 12:52 PM
NCT ID: NCT01427595
Description: None
Frequency Threshold: 0
Time Frame: From start of study procedures until 30 days post study drug.
Study: NCT01427595
Study Brief: Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metformin, Progesterone , Estrace 12 weeks Metformin oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (2X) oral estrace, 0.5-1 mg once a day for seven days (2X) Metformin: 500-2000 mg PO BID (X12 weeks) Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (X2) estrace: oral estrogen (estrace, 0.5-1 mg once a day for seven days)- X2 0 None 0 25 12 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision switched from near to farsighted NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
SVT NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
UTI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
fainting NON_SYSTEMATIC_ASSESSMENT General disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
heartburn NON_SYSTEMATIC_ASSESSMENT General disorders None View