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: 2025-12-24 @ 5:20 PM
Ignite Modification Date: 2025-12-25 @ 2:56 PM
NCT ID: NCT00056550
Description: All 14 patients who received rhAT were evaluated for the occurrence of treatment-emergent AEs from the time of their initial bolus dose up to and including 30 days after administration of their last dose of rhAT and for the development of antibodies to rhAT out to 90 days following treatment.
Frequency Threshold: 5
Time Frame: Adverse event data was collected for duration of study up to 90 days post study drug administration.
Study: NCT00056550
Study Brief: Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Recombinant Human Antithrombin (rhAT) Infusion Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity \< or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels \> 80% and \< 120% of normal. None None 6 14 8 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA (6.1) View
Thrombophlebitis Deep SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (6.1) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (6.1) View
Hemorrhage NOS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (6.1) View
Convulsions Grand Mal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (6.1) View
Fracture Trauma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (6.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post-operative pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (6.1) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (6.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (6.1) View
Infection SYSTEMATIC_ASSESSMENT General disorders MedDRA (6.1) View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (6.1) View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (6.1) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (6.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (6.1) View