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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT00724594
Description: None
Frequency Threshold: 0
Time Frame: Mothers were monitored for Adverse Events for up to 2 days after treatment. Infants were assessed for Adverse Events until discharge, Serious Adverse Events up to 30 days post-treatment.
Study: NCT00724594
Study Brief: Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NAC Maternal Mothers of infants treated with N-acetylcysteine None None 0 11 2 11 View
Control Maternal Mothers of infants treated with saline None None 0 11 2 11 View
NAC Infant Infants treated with N-acetylcysteine None None 4 12 5 12 View
Control Infant Infants treated with saline None None 3 12 3 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders None View
IVH 1-2 days of age SYSTEMATIC_ASSESSMENT Nervous system disorders None View
IVH 5-7 days of age SYSTEMATIC_ASSESSMENT Nervous system disorders None View
NEC within 30 days SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypoxic Ischemic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Culture Proven Sepsis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash/Hives SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shortness of breath/wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Prolonged PT time SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View