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 @ 11:36 PM
Ignite Modification Date: 2025-12-25 @ 9:25 PM
NCT ID: NCT01660256
Description: Only adverse events that occurred after the start of study treatment were evaluated. Safety analysis set consisted of all subjects who had received the investigational product at least once.
Frequency Threshold: 1
Time Frame: Treatment period (4 weeks)
Study: NCT01660256
Study Brief: Confirmatory 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 4 times a day for 4 weeks. 0 None 0 84 23 84 View
Placebo One drop of 0% OPC-12759 ophthalmic solution was instilled into each eye 4 times a day for 4 weeks. 0 None 0 83 11 83 View
OPC-12759 Suspension One drop of 2% OPC-12759 ophthalmic suspension was instilled into each eye 4 times a day for 4 weeks. 0 None 0 42 11 42 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormal sensation in eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Ver. 15.0 View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Ver. 15.0 View
Ocular discomfort NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Ver. 15.0 View
Ulcerative keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Ver. 15.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Ver. 15.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Ver. 15.0 View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Ver. 15.0 View
Periproctitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Ver. 15.0 View
Adenoviral conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Ver. 15.0 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Ver. 15.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Ver. 15.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Ver. 15.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 15.0 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 15.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 15.0 View
Glucose urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 15.0 View
White blood cell count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 15.0 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 15.0 View
Adenoma benign NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Ver. 15.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Ver. 15.0 View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Ver. 15.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Ver. 15.0 View