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 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT03406104
Description: None
Frequency Threshold: 5
Time Frame: from 2 to 5 years
Study: NCT03406104
Study Brief: RESCUE and REVERSE Long-term Follow-up
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Subjects All eyes that received the Sham. Each participant was randomly assigned GS010 in either the right or left eye, the eye not assigned GS010 received the sham procedure. The eye assigned to the Sham received one single sham intravitreal (IVT) injection, which was performed by applying pressure to the eye at the location of a typical IVT injection procedure, using the blunt end of a syringe without a needle. The same participants also received GS010 in the right or left eye, which did not receive the sham procedure, at the same study visit. 2 None 8 62 19 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
humerus fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
lower limb fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
cerebral haemorrage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
glioblastoma multiforme SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
appenditis perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (19.0) View
Gamma-Glutamyltransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Intraocular Pressure Increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (19.0) View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View