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 @ 11:52 PM
Ignite Modification Date: 2025-12-25 @ 9:47 PM
NCT ID: NCT00431951
Description: Study drug was administered to each dosing group cohort for 21 days and subjects were followed for an additional 30 to 32 days. AEs were recorded throughout this time period.
Frequency Threshold: 0
Time Frame: 7 weeks
Study: NCT00431951
Study Brief: Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ST-246 250 mg 250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. None None 0 8 6 8 View
ST-246 400mg 400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21. None None 0 8 2 8 View
ST-246 800 mg 800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21. None None 0 8 5 8 View
Placebo Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21. None None 0 6 4 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormal Eye Sensation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
Backpain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Hand Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Pharyngolaryngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Procedural Complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View