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 @ 7:46 PM
Ignite Modification Date: 2025-12-25 @ 5:23 PM
NCT ID: NCT00165503
Description: None
Frequency Threshold: 0
Time Frame: The period for reporting adverse events were 30 days from the participant's date of surgery.
Study: NCT00165503
Study Brief: Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. None None 5 16 0 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pericardial effusion with tamponade None Respiratory, thoracic and mediastinal disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Progression of disease None Respiratory, thoracic and mediastinal disorders None View
Hypocalcemia None Blood and lymphatic system disorders None View
Chylothorax None Respiratory, thoracic and mediastinal disorders None View
Aspiration pneumonia None Respiratory, thoracic and mediastinal disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Elevated troponin None Blood and lymphatic system disorders None View
Other Events(If Any):