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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:54 PM
NCT ID: NCT01912456
Description: The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
Frequency Threshold: 5
Time Frame: During the treatment phase, up to 32 weeks.
Study: NCT01912456
Study Brief: A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of 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
CSL830 (40) Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks. 0 None 1 43 10 43 View
CSL830 (60) High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks. 0 None 0 43 17 43 View
Placebo High High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks 0 None 1 44 12 44 View
Placebo Low Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks 0 None 1 42 12 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hereditary angioedema SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA (18.0) View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Injection site edema SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View