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 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 12:34 AM
NCT ID: NCT00548860
Description: None
Frequency Threshold: 5
Time Frame: 1 year and 5 months
Study: NCT00548860
Study Brief: Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
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) Intravenous (IV) iron None None 6 996 9 996 View
Standard Medical Care (SMC) SMC for postpartum and heavy uterine bleeding subjects with anemia None None 22 1022 79 1022 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Abdominal adhesions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Necrotising Fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Postoperative abscess SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Endometritis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Endometrial cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
Postpartum hemorrhage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions CTCAE (3.0) View
Retained placenta or membranes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions CTCAE (3.0) View
Uterine hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View