Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:15 PM
Ignite Modification Date: 2025-12-25 @ 12:53 PM
NCT ID: NCT01175395
Description: Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01175395
Study Brief: 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (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
IBI-20089/Lucentis Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results. None None 1 10 7 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
fracture of sacrum SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders SNOMED CT View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
subconjunctival hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View
cataract surgery SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View
temporal pallor of optic nerve SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View
retinal hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View
ptosis of eyelid SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View
anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders SNOMED CT View
ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View
vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View
posterior vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View
infective vaginitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders SNOMED CT View
food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
watery eye NON_SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View