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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT02484456
Description: None
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT02484456
Study Brief: Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in 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
AV 101 (4-chlorokynurenine) 1,080 mg for 1 Week Daily oral dose of AV 101 (4-chlorokynurenine) monotherapy 1,080mg/day for seven days 0 None 1 19 9 19 View
AV 101 (4-chlorokynurenine) 1,440 mg for 1 Week Daily oral dose of AV 101 (4-chlorokynurenine) monotherapy 1,440 mg/day for seven days 0 None 1 19 7 19 View
Placebo 2 Weeks Daily dose of placebo pill for two weeks 0 None 0 19 6 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cold sweat SYSTEMATIC_ASSESSMENT General disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Advanced sleep phase SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Motor dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensory loss SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleep phase rhythm disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pharyngitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reflux gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View