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 @ 5:11 AM
Ignite Modification Date: 2025-12-26 @ 4:16 AM
NCT ID: NCT01470027
Description: None
Frequency Threshold: 0
Time Frame: Baseline (day 0) to 4 weeks after intervention start
Study: NCT01470027
Study Brief: N-Acetylcysteine for Neuroprotection in Parkinson's Disease
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-acetylcysteine 1800mg - Parkinson's Patient Parkinson's patient N-acetylcysteine 1800mg/day for 30 days N-acetylcysteine: 900mg NAC effervescent tablets 0 None 0 7 2 7 View
N-acetylcysteine 3600mg -Parkinson's Patient Parkinson's patient N-acetylcysteine 3600mg daily for 30 days N-acetylcysteine: 900mg NAC effervescent tablets 0 None 0 7 2 7 View
Placebo -Parkinson's Patient Parkinson's patient Placebo effervescent tablets daily for 30 days Placebo: effervescent tablets 0 None 0 7 2 7 View
N-acetylcysteine 1800mg - Healthy Volunteer Healthy Volunteer N-acetylcysteine 1800mg/day for 30 days N-acetylcysteine: 900mg NAC effervescent tablets 0 None 0 9 2 9 View
N-acetylcysteine 3600mg -Healthy Volunteer Healthy Volunteer N-acetylcysteine 3600mg daily for 30 days N-acetylcysteine: 900mg NAC effervescent tablets 0 None 0 8 2 8 View
Placebo -Healthy Volunteer Healthy Volunteer Placebo effervescent tablets daily for 30 days Placebo: effervescent tablets 0 None 0 9 2 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Metallic taste, Occasional light-headed on standing NON_SYSTEMATIC_ASSESSMENT General disorders None View
nausea and vomiting, loss of appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Incidental finding in MRI SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shoulder and neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Occasional skin itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
puffy face, increased heart rate NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lightheaded after exercise, daytime napping NON_SYSTEMATIC_ASSESSMENT General disorders None View