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 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT00859469
Description: None
Frequency Threshold: 5
Time Frame: 50 months
Study: NCT00859469
Study Brief: Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oxaliplatin and Gemcitabine The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours. None None 11 28 27 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elevated Bilirubin NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders SNOMED CT View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED CT View
Elevated AST NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders SNOMED CT View
Elevated ALT NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders SNOMED CT View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED CT View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders SNOMED CT View
Elevated alkaline phosphatase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders SNOMED CT View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED CT View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED CT View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED CT View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED CT View
Elevated alkaline phosphatase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders SNOMED CT View
Elevated AST NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders SNOMED CT View
Elevated ALT NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders SNOMED CT View
Nausea/Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Peripheral neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders SNOMED CT View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SNOMED CT View
Vertigo NON_SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders SNOMED CT View