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 @ 2:49 PM
Ignite Modification Date: 2025-12-25 @ 1:16 PM
NCT ID: NCT03318159
Description: Definition of adverse event and serious adverse event, used to collect adverse event informations are not differs from the clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT03318159
Study Brief: Posaconazole Prophylaxis During ATG Treatment for hMDS/AA 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
Posaconazole Prophylaxis Group aplastic anemia / hypoplastic myelodysplastic syndrome patients undergoing antithymocyte globulin treatment and receiving posaconazole as prophylaxis antifungal agent Posaconazole: Dosing of posaconazole Posaconazole tablet 300 mg twice daily on day 1; Maintenance dose: 300 mg once daily on day 2 and thereafter. Treatment period: 4 weeks \*if posaconazole tablet intolerance: posaconazole suspension 200mg tid 6 None 4 20 4 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Liver function abnormality SYSTEMATIC_ASSESSMENT Investigations None View