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 @ 7:15 PM
Ignite Modification Date: 2025-12-25 @ 4:52 PM
NCT ID: NCT00138203
Description: None
Frequency Threshold: 5
Time Frame: From the time subjects started therapy until 30 days after they completed therapy
Study: NCT00138203
Study Brief: Suberoylanilide Hydroxamic Acid in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SAHA Suberoylanilide Hydroxamic Acid (SAHA) None None 9 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperglycemia None Endocrine disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Vascular disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pnemonia None Respiratory, thoracic and mediastinal disorders None View
Lymphopenia None Blood and lymphatic system disorders None View
Hyperglycemia None Endocrine disorders None View
Fatigue None General disorders None View
Neutropenia None Blood and lymphatic system disorders None View