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 @ 2:53 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT01166659
Description: Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Frequency Threshold: 5
Time Frame: An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative).
Study: NCT01166659
Study Brief: Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ocular Adverse Events At risk population for ocular adverse events is included with unit of eyes. None None 8 50 36 50 View
Non-Ocular Adverse Events At risk population for non-ocular adverse events is included with unit of subjects None None 2 48 0 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Secondary surgical intervention SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
IOP above target SYSTEMATIC_ASSESSMENT Investigations None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyphema SYSTEMATIC_ASSESSMENT Eye disorders None View
BCVA loss ≥ 2 lines at/after 3 months postoperatively SYSTEMATIC_ASSESSMENT Eye disorders None View
Secondary surgical intervention: IOP management SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
IOP ≥ 10 mmHg over baseline or > 30 mmHg at/after 1 month postoperatively SYSTEMATIC_ASSESSMENT Investigations None View
CyPass device obstruction SYSTEMATIC_ASSESSMENT Investigations None View
Secondary surgical intervention: Cataract removal SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Secondary surgical intervention: CyPass obstruction lysis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View