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 @ 3:02 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT02584959
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were reported from the time the informed consent was signed through 7 days afer the last dose of investigational product was received (week 1 to 15 for treatment period 1 and 2).
Study: NCT02584959
Study Brief: Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment C1 INH Participants who received C1 Esterase Inhibitor (C1 INH) treatment (in period 1 of the Experimental/Placebo arm, in period 2 of the Placebo/Experimental arm and in period 1 and 2 of the Experimental/Experimental arm). 0 None 2 71 23 71 View
Treatment Placebo Participants who received Placebo treatment (in period 2 of the Experimental/Placebo arm and in period 1 of the Placebo/Experimental arm). 0 None 3 57 14 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hereditary angioedema NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 19.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View