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 @ 10:21 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT00928135
Description: None
Frequency Threshold: 0
Time Frame: For the duration of the study treatment (up tp 14 days) and Up to 7 days after last study drug inhalation for a total of up to 21 days
Study: NCT00928135
Study Brief: Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
7% Hypertonic Saline 5 ml of 7% saline twice daily Saline: 7% hypertonic saline solution for aerosol; Dosage: 5 ml twice a day (BID) 0 None 2 29 11 29 View
Hypertonic Xylitol 5 ml of 15% xylitol twice daily Xylitol: 15% xylitol solution for aerosol; Dosage: 5 ml twice a day (BID) 0 None 0 30 8 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Distal intestinal obstruction syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abnormal laboratory values SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bowel obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
flu NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View