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 @ 4:41 PM
Ignite Modification Date: 2025-12-25 @ 2:30 PM
NCT ID: NCT00797966
Description: The Safety Sample comprises those randomized participants in Phase B who received at least one dose of double-blind study medication as indicated on the dosing record.
Frequency Threshold: 5
Time Frame: From Randomization to 30 (+2) days after the end of Phase B (Week 14/End of treatment).
Study: NCT00797966
Study Brief: Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
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-34712 0.15 mg Fixed Dose The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination. None None 0 62 21 62 View
OPC-34712 0.5 ± 0.25 mg Low Dose The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination. None None 0 120 37 120 View
OPC-34712 1.5 ± 0.5 mg High Dose The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination. None None 2 121 47 121 View
Placebo The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination. None None 1 126 37 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Renal mass NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Radius fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Ulna fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View