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 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT01021956
Description: systematic Assessment : Regular investigator assessment
Frequency Threshold: 1
Time Frame: 12 weeks
Study: NCT01021956
Study Brief: Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1A 2.5 mg/kg - 25 Joules/cm² None None 1 3 3 3 View
Group 1B 2.5 mg/kg - 12.6 Joules/cm² None None 0 3 1 3 View
Group 1C 2.5 mg/kg - 18.9 Joules/cm² None None 0 3 0 3 View
Group 2 2.5 mg/kg - 50 Joules/cm² None None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
retinal vascular occlusion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (Unspecified) View
Visual Acuty reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Retinal pigment epitheliopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
macular ischaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Retinal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View