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 @ 2:41 PM
Ignite Modification Date: 2025-12-25 @ 1:12 PM
NCT ID: NCT01530659
Description: Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participant level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Frequency Threshold: 0
Time Frame: Serious and Other (Not Including Serious) Adverse Events were collected only for randomized participants through study completion, an average of 36 months. However, mortality is noted for one participant who passed away due to unrelated issues before being randomized.
Study: NCT01530659
Study Brief: Retinal Imaging in CNTF -Releasing Encapsulated Cell Implant Treated Patients for Early-stage Retinitis Pigmentosa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NT-501 Implant A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (to receive the NT-501 implant) or the fellow eye (Control-to receive sham surgery). Primary eye will receive the NT-501 implant 0 None 4 22 2 22 View
Sham Surgery A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (to receive the NT-501 implant) or the fellow eye (Control-to receive sham surgery). 0 None 4 22 1 22 View
Prior to Randomization One participant was consented and enrolled but died before being randomized to receive the study intervention. 1 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Reversible Cardiac Vasospasm NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Total Eye Disorders NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Clinically Significant Cystoid Macular Edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Secondary Surgical Intervention (excluding Posterior Capsulotomy) SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular discomfort SYSTEMATIC_ASSESSMENT Eye disorders None View
Reduced peripheral visual field SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epiretinal membrane SYSTEMATIC_ASSESSMENT Eye disorders None View
Pelvic fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View