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 @ 12:59 AM
Ignite Modification Date: 2025-12-25 @ 11:12 PM
NCT ID: NCT01471093
Description: Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
Frequency Threshold: 1
Time Frame: Treatment period (2 days up to 15 days)
Study: NCT01471093
Study Brief: Safety Study of OPC-12759 Ophthalmic Solution
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OPC-12759 Solution One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation). 0 None 0 50 6 50 View
OPC-12759 Suspension One drop of OPC-12759 ophthalmic suspension was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation). 0 None 0 50 2 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chalazion NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Ver. 14.1 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Ver. 14.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Ver. 14.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 14.1 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 14.1 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 14.1 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 14.1 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 14.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Ver. 14.1 View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Ver. 14.1 View