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 @ 7:35 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT00534703
Description: None
Frequency Threshold: 5
Time Frame: 6 Months
Study: NCT00534703
Study Brief: Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients With Chronic Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo (saline solution) Placebo: Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion. 0 None 0 1 1 1 View
AAV1/SERCA2A SERCA gene therapy AAV1/SERCA2a: AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10\^13 DRP (DNase resistant particles) 1 None 2 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
LVAD Alarm SYSTEMATIC_ASSESSMENT Product Issues MedDRA (19.1) View
Worsening heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.1) View
Heart transplantation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (19.1) View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.1) View
Device Alarm Issue SYSTEMATIC_ASSESSMENT Product Issues MedDRA (19.1) View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.1) View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.1) View
Vessel puncture, site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.1) View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.1) View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.1) View
Iron deficiency - Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (19.1) View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.1) View
Site Bleeding SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View