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 @ 2:55 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT00585559
Description: Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
Frequency Threshold: 0
Time Frame: Baseline to 21 days
Study: NCT00585559
Study Brief: Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm
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 IV Infusion at 0.5 gm Hourly N-acetylcysteine IV infusion at 0.5 gm hourly 3 None 1 16 1 16 View
Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly Placebo for N-acetylcysteine IV infusion at 0.5 gm hourly 6 None 4 17 1 17 View
Acetaminophen Plus N-acetylcysteine IV Infusion Acetaminophen 1.5gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly 0 None 2 11 1 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vasospasm SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Ischemic Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View