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 @ 3:41 PM
Ignite Modification Date: 2025-12-25 @ 1:50 PM
NCT ID: NCT00396292
Description: None
Frequency Threshold: 5
Time Frame: 9 months
Study: NCT00396292
Study Brief: Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Iron Tablets 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42 None None 4 178 61 178 View
VIT-45 A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered None None 4 174 40 174 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Peripartum cardiomyopathy None Pregnancy, puerperium and perinatal conditions CTCAE (3.0) View
Cardiac failure None Cardiac disorders CTCAE (3.0) View
Postoperative infection None Infections and infestations CTCAE (3.0) View
Appendicitis None Infections and infestations CTCAE (3.0) View
Cholecystitis None Hepatobiliary disorders CTCAE (3.0) View
Cardiac failure congestive None Cardiac disorders CTCAE (3.0) View
Thrombophlebitis None Vascular disorders CTCAE (3.0) View
Major depression None Psychiatric disorders CTCAE (3.0) View
Cholelithiasis None Hepatobiliary disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation None Gastrointestinal disorders CTCAE (3.0) View
Nausea None Gastrointestinal disorders CTCAE (3.0) View
Headache None Nervous system disorders CTCAE (3.0) View