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: 2025-12-25 @ 4:49 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT04597918
Description: Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of faricimab in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
Frequency Threshold: 5
Time Frame: From first dose of study drug until ≥28 days to <35 days after the last dose of study drug (up to 24 weeks)
Study: NCT04597918
Study Brief: A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Faricimab Participants received 6 doses of faricimab (one 6-mg faricimab intravitreal \[IVT\] injection every 28 days \[Q4W\]) starting at Day 1 and ending on the Day 140 visit. Participants returned for a safety follow-up visit (SFV) after ≥28 days and within \<35 days following their last study treatment. 1 None 8 99 21 99 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.1 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25.1 View
Spinal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA version 25.1 View
Toe amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA version 25.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diabetic retinal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.1 View
Retinal exudates SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 25.1 View