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: 2025-12-25 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
NCT ID: NCT01339858
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01339858
Study Brief: The Effect of N-Acetyl Cysteine on Cortical Erosion in Early Stage Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
N-Acetyl Cysteine NAC and matched placebo will be supplied in unmarked capsules. Each NAC capsule will contain 600 mg of NAC. Dosing will begin at 600 mg/d and titrated up over 5 weeks until a maximum dose of 3600 mg/d is reached. Dose adjustments downward to 1920 mg/d will be permitted if tolerability issues are encountered at the maximum dose. None None 3 30 28 30 View
Sugar Pill matched placebo sugar pill: matched placebo will be supplied in unmarked capsules. Dosing regimen will be the same as in the N-Acetyl Cysteine arm. None None 2 30 27 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma Exacerbation None Respiratory, thoracic and mediastinal disorders None View
Psychosis Exacerbation None Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyskinesia None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Nausea and Vomiting None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Nasal Congestion None General disorders None View
Toothache None Musculoskeletal and connective tissue disorders None View
Upper Respiratory Infection None Infections and infestations None View
Weight Gain None Metabolism and nutrition disorders None View
Hyperlipidemia None Metabolism and nutrition disorders None View
Dyspepsia None Cardiac disorders None View
Headache None Nervous system disorders None View
Suicidal Ideation None Psychiatric disorders None View
Sedation None General disorders None View
Insomnia None General disorders None View
Illness Exacerbation None Psychiatric disorders None View
Depressed Mood None Psychiatric disorders None View