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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT02169466
Description: None
Frequency Threshold: 0
Time Frame: Just before drug administration until 72 h post-dose
Study: NCT02169466
Study Brief: Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BIA 9-1067 25 mg BIA 9-1067 25 mg OPC Opicapone None None 0 21 2 21 View
BIA 9-1067 50 mg BIA 9-1067 50 mg OPC Opicapone None None 0 22 4 22 View
BIA 9-1067 100 mg BIA 9-1067 100 mg OPC Opicapone None None 0 22 3 22 View
Placebo Placebo, PLC None None 0 21 2 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis None Infections and infestations MedDRA (10.0) View
Oral herpes None Infections and infestations MedDRA (10.0) View
Pharyngitis None Infections and infestations MedDRA (10.0) View
Respiratory tract infection None Infections and infestations MedDRA (10.0) View
Blood creatine phosphokinase increased None Investigations MedDRA (10.0) View
Headache None Nervous system disorders MedDRA (10.0) View
Depression None Psychiatric disorders MedDRA (10.0) View
Rhinorrhea None Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Rash None Skin and subcutaneous tissue disorders MedDRA (10.0) View