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: 2025-12-25 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 2:59 AM
NCT ID: NCT00529802
Description: These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).
Frequency Threshold: 5
Time Frame: None
Study: NCT00529802
Study Brief: Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell 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
Everolimus All patients were to receive 10mg everolimus (RAD001) daily. These results are based on n=56 patients who were evaluable for toxicity. None None 6 56 55 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ear, nose and throat examination abnormal NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hemorrhage nasal NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Investigations None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nail changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurological disorder NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain - Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash desquamating NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rigors/chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Taste alteration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dermatology/Skin - Other (Specify) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
General symptom NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pulmonary - Other(specify) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View