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: 2025-12-26 @ 4:03 PM
Ignite Modification Date: 2025-12-26 @ 4:03 PM
NCT ID: NCT02034006
Description: Safety Population: All subjects who received at least one dose of ranibizumab and had at least one post-baseline safety assessment.
Frequency Threshold: 1
Time Frame: Adverse events were collected from time of treatment until exit from the study (approximately 12 months)
Study: NCT02034006
Study Brief: A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ranibizumab All subjects who received at least one dose of ranibizumab and had at least one post-baseline safety assessment. None None 7 200 26 200 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.1) View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.1) View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.1) View
Klebsiella sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Expired product administered (Study Eye) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.1) View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (18.1) View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Choroidal neovascularisation (Non-study Eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.1) View
Choroidal neovascularisation (Study Eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.1) View
Conjunctival haemorrhage (Study Eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.1) View
Conjunctival hyperaemia (Both Eyes) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.1) View
Ocular hypertension (Both Eyes) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.1) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View