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 @ 4:51 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT00593450
Description: Adverse events were ascertained through monthly questioning of patients by study coordinators who were aware of study-group assignments; events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) system, version 10. A medical monitor who was unaware of study-group assignments reviewed serious adverse events.
Frequency Threshold: 0
Time Frame: Adverse events were collected at 1 year.
Study: NCT00593450
Study Brief: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1-Lucentis Monthly Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing. None None 53 301 3 301 View
2-Avastin Monthly Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing. None None 64 286 4 286 View
3-Lucentis as Needed Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. None None 61 298 0 298 View
4-Avastin as Needed Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. None None 77 300 0 300 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Any other system organ class SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Benignor malignant neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Death from any cause SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Death from vascular causes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Injury or procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Nonfatal myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Nonfatal stroke SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Surgical or medical procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Venous thrombotic event SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Endophthalmitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
Pseudoendophthalmitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View