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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT00627705
Description: We analyzed all subjects who had follow-up data available.
Frequency Threshold: 0
Time Frame: Baseline and 4, 8 and 12 Weeks
Study: NCT00627705
Study Brief: A Study of N-Acetyl Cysteine in Children With Autism
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sugar Pill Placebo or sugar pill Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks Entire intervention lasts for 12 weeks (drug administration is continuous). None None 0 15 14 15 View
N-Acetyl Cysteine active compound N-Acetyl Cysteine N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks Entire intervention lasts for 12 weeks (drug administration is continuous). None None 0 14 13 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Akathisia SYSTEMATIC_ASSESSMENT General disorders None View
Excitement/ Agitation SYSTEMATIC_ASSESSMENT General disorders None View
Increased Motor Activity SYSTEMATIC_ASSESSMENT General disorders None View
Tremor SYSTEMATIC_ASSESSMENT General disorders None View
Syncope/Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Depressive Affect SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT General disorders None View
Increased Salivation SYSTEMATIC_ASSESSMENT General disorders None View
Sweating SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View