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 @ 7:52 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT00997204
Description: None
Frequency Threshold: 5
Time Frame: 7 days from the beginning of each phase
Study: NCT00997204
Study Brief: EASSI - Evaluation of the Safety of Self-Administration With Icatibant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Naive Subjects Administered Icatibant by Health Care Provider The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject. None None 0 22 7 22 View
Subjects Who Self-administered Icatibant (Naive) Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision. None None 0 19 6 19 View
Subjects Who Self-administered Icatibant (Non-naive) Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision. None None 0 78 21 78 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hereditary Angioedema SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA (8.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.1) View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (8.1) View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (8.1) View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders MedDRA (8.1) View
Local Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (8.1) View
Edema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (8.1) View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA (8.1) View
Skin Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (8.1) View
Laryngeal edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (8.1) View