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 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT03878069
Description: For mortality, all incidences are reported. For non-fatal serious adverse events (SAEs) and non-serious adverse events, due to the nature of the disease, sites were asked to report only those events deemed to be at least possibly related to Revcovi treatment, along with clinically meaningful laboratory abnormalities.
Frequency Threshold: 0
Time Frame: At any time during the study. Duration of participation was a minimum of 24 months, or until undergoing successful treatment with stem cell transplant or hematopoietic stem cell gene therapy.
Study: NCT03878069
Study Brief: Registry Study of Revcovi Treatment in Patients With ADA-SCID
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients With ADA-SCID in Need of ERT Treatment All participants will receive Revcovi and will be monitored for adverse events (AEs) throughout their participation in the study. Only AEs deemed at least possibly related to Revcovi treatment will be documented. 1 None 0 32 4 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.1 View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
Exposure via skin contact NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View