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 @ 1:06 AM
Ignite Modification Date: 2025-12-25 @ 11:18 PM
NCT ID: NCT00395993
Description: None
Frequency Threshold: 5
Time Frame: 11 months
Study: NCT00395993
Study Brief: Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ferric Carboxymaltose (FCM) Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered None None 3 230 120 230 View
Oral Iron Tablets 325 mg tablets TID on Days 0 through Day 42 None None 3 226 133 226 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Uterine hemorrhage None Reproductive system and breast disorders CTCAE (3.0) View
Transient ischemic attack None Nervous system disorders CTCAE (3.0) View
Uterine leiomyoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
Chest pain None General disorders CTCAE (3.0) View
Pelvic inflammatory disease None Infections and infestations CTCAE (3.0) View
Abdominal pain None Gastrointestinal 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
Diarrhea None Gastrointestinal disorders CTCAE (3.0) View
Abdominal pain None Gastrointestinal disorders CTCAE (3.0) View
Nausea None Gastrointestinal disorders CTCAE (3.0) View
Fatigue None General disorders CTCAE (3.0) View
Nasopharyngitis None Infections and infestations CTCAE (3.0) View
Blood phosphorus decreased None Renal and urinary disorders CTCAE (3.0) View
Headache None Nervous system disorders CTCAE (3.0) View