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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT00912093
Description: Subjects were analyzed according to the treatment actual received
Frequency Threshold: 5
Time Frame: Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis
Study: NCT00912093
Study Brief: A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Controlled Phase - Icatibant (Randomized) Subjects who were randomized to treatment and received a single subcutaneous injection of icatibant 30 mg in the controlled phase None None 0 46 8 46 View
Controlled Phase -Placebo (Randomized) Subjects who were randomized to treatment and received a single subcutaneous injection of matching placebo in the controlled phase None None 5 46 12 46 View
Controlled Phase - Icatibant (Open Label) Subjects who were not randomized and received a single subcutaneous injection of icatibant 30 mg in the controlled phase None None 0 6 0 6 View
Open Label Extension - Icatibant (Open Label) Subjects who treated with icatibant 30 mg in the open label extension phase None None 7 82 23 82 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary Embolism None Respiratory, thoracic and mediastinal disorders None View
Cholecystitis None Hepatobiliary disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Myocardial infarction None Cardiac disorders None View
Hereditary angioedema None Congenital, familial and genetic disorders None View
Gastroenteritis None Infections and infestations None View
Tracheostomy None Surgical and medical procedures None View
Arrhythmia None Cardiac disorders None View
Non-Cardiac Chest Pain None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hereditary angioedema None Congenital, familial and genetic disorders None View
Headache None Nervous system disorders None View
Upper Respiratory Tract Infection None Infections and infestations None View