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 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT03344003
Description: There were no treatment-related ADRs during the study
Frequency Threshold: 0
Time Frame: Adverse drug reactions were monitored throughout the study from first treatment through to study termination, a maximum of 2 years
Study: NCT03344003
Study Brief: Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Wilate® Retrospective Cohort The population consists of all patients who had received Wilate immune tolerance induction (ITI) therapy within 3 years of enrolment. 0 None 1 8 0 8 View
Wilate® Prospective Cohort The population consists of all patients who were currently on Wilate ITI, had just initiated ITI, or were planned to initiate ITI treatment with Wilate. 0 None 1 6 1 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Device-related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View