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: 2025-12-26 @ 2:43 PM
Ignite Modification Date: 2025-12-26 @ 2:43 PM
NCT ID: NCT02555306
Description: None
Frequency Threshold: 5
Time Frame: From Visit 1 (Day 1) to Study Exit (Day 90)]
Study: NCT02555306
Study Brief: A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.5 mg of DE-122 Single intravitreal injection of Low Dose DE-122 0 None 0 3 0 3 View
1.0 mg of DE-122 Single intravitreal injection of Medium-Low Dose DE-122 0 None 0 3 2 3 View
2.0 mg of DE-122 Single intravitreal injection of Medium-High Dose DE-122 0 None 0 3 2 3 View
4.0 mg of DE-122 Single intravitreal injection of High Dose DE-122 0 None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Deposit eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Foreign body sensation in eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Hyphaema SYSTEMATIC_ASSESSMENT Eye disorders None View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View