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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:10 PM
NCT ID: NCT01255358
Description: Please note that non serious Adverse Events were monitored/assessed without regard to the specific Adverse Event Term but only by SOC.
Frequency Threshold: 5
Time Frame: The adverse events were monitored and collected during the 6 month study period
Study: NCT01255358
Study Brief: Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Teleangiectasia Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ery-Dex Patients treated with monthly treatment of Ery-Dex (dexamethasone sodium phosphate encapsulated in autologous erythrocytes) 0 None 2 22 15 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General disorders SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
immune disorders SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (10.0) View
infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
respiratory disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View