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 @ 2:39 PM
Ignite Modification Date: 2025-12-25 @ 1:11 PM
NCT ID: NCT00125359
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00125359
Study Brief: Study of Tarceva and Targretin Oral Capsules in Patients With Advanced 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
Single Arm Erlotinib + Bexarotene All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg. 4 None 30 42 14 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post-obstructive Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bacterial pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Declining respiratory status NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anxiety Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Hemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
INR increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations None View
Increased white blood cell count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Investigations - Other, elevated granulocytes NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Proximal muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hallucinations NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cholesterol high NON_SYSTEMATIC_ASSESSMENT Investigations None View
Mouth sores NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arm pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View