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 @ 7:24 PM
Ignite Modification Date: 2025-12-25 @ 5:03 PM
NCT ID: NCT00126503
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00126503
Study Brief: Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney 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
Phase II Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1. None None 8 21 21 21 View
Phase I Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1. None None 17 48 48 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Edema-limb None General disorders None View
Hemorrhage, pulmonary/upper respiratory-nose None Respiratory, thoracic and mediastinal disorders None View
Pain-chest wall None Musculoskeletal and connective tissue disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
CNS cerebrovascular ischemia None Nervous system disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Musculoskeletal/soft tissue-Other None Musculoskeletal and connective tissue disorders None View
Neuropathy - sensory None Nervous system disorders None View
Pain-abdomen NOS None Gastrointestinal disorders None View
Pain-joint None Musculoskeletal and connective tissue disorders None View
Proteinuria None Renal and urinary disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Somnomolence/depressed level of consciousness None Nervous system disorders None View
Hypercalcemia None Metabolism and nutrition disorders None View
Cardiac ischemia/infarction None Cardiac disorders None View
Hyperuricemia None Renal and urinary disorders None View
Vascular-other None Vascular disorders None View
Infection with unknown ANC-pancreas None Infections and infestations None View
Infection with unknown ANC-lung (pneumonia) None Infections and infestations None View
Death not associated with CTCAE term-Disease progression NOS None General disorders None View
Fracture None Musculoskeletal and connective tissue disorders None View
Supraventricular and nodal arrhythmia-atrial fibrillation None Cardiac disorders None View
Thrombosis/thrombus/embolism None Vascular disorders None View
Infection-Other None Infections and infestations None View
Infection with Grade 1 or 2 neutrophils (ANC < 1.0 x 10e9/L)-skin (cellulitis) None Infections and infestations None View
Hypertension None Vascular disorders None View
Hyperbilirubinemia None Metabolism and nutrition disorders None View
Wound complication, non-infectious None General disorders None View
Obstruction, GI-gallbladder None Gastrointestinal disorders None View
Renal failure None Renal and urinary disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Cardiac General-other None Cardiac disorders None View
Dehydration None Metabolism and nutrition disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils-bone (osteomyelitis) None Infections and infestations None View
Pain-back None Musculoskeletal and connective tissue disorders None View
Perforation, GI-colon None Gastrointestinal disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Supraventricular and nodal arrhythmia-atrial flutter None Cardiac disorders None View
Fatigue None General disorders None View
Fever (in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L) None General disorders None View
stricture/stenosis (including anastomotic), GI-jejunum None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Oral mucositis None Gastrointestinal disorders None View
palmar-plantar paresthesia None Skin and subcutaneous tissue disorders None View
weight loss None Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
allergic reaction/hypersensivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
ALT/SGPT (serum glutamine pyruvic transminase) SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
AST, SGOT (serum glutamine oxaloacetic transminase) SYSTEMATIC_ASSESSMENT Investigations None View
Bronchospasm-wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bruising (in absence of Grade 3/4 thromboctyopenia) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constitutional symptoms Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Dental-teeth None Gastrointestinal disorders None View
Dermatology/Skin-Other None Skin and subcutaneous tissue disorders None View
Diarrhea None Gastrointestinal disorders None View
Distension/bloating, abdominal None Gastrointestinal disorders None View
Dizziness None Nervous system disorders None View
Dry eye syndrome None Eye disorders None View
Dry mouth/salivary gland (xerostomia) None Gastrointestinal disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Dysphagia None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Edema head and neck None General disorders None View
Edema limb None General disorders None View
Esophagitis None Gastrointestinal disorders None View
Extemity-lower (gait/walking) None Musculoskeletal and connective tissue disorders None View
Fatigue None General disorders None View
Fever (in the absence of neutropenia, with neutropenia defined as ANC < 1.0 x 10e9/L None General disorders None View
fistula-GI anus None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Flu-like syndrome None General disorders None View
Flushing None Vascular disorders None View
Gastrointestinal-Other None Gastrointestinal disorders None View
hair loss-scalp or body None Skin and subcutaneous tissue disorders None View
Heartburn, dyspepsia None Gastrointestinal disorders None View
Hemoglobin None Infections and infestations None View
Hemorrhage, GI-lower GI NOS None Gastrointestinal disorders None View
Hemorrhage, GI oral cavity None Gastrointestinal disorders None View
Hemorrhage, GI rectum None Gastrointestinal disorders None View
Hemorrhage, GU urinary None Renal and urinary disorders None View
Hemorrhage, GU vaginal None Reproductive system and breast disorders None View
Hemorrhage, pulmonary/upper respiratory-nose None Respiratory, thoracic and mediastinal disorders None View
Hemorrhoids None Gastrointestinal disorders None View
Hypercalcemia None Investigations None View
Hypercholesterolemia None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypertension None Vascular disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Infection-Other None Infections and infestations None View
Infection with normal ANC or Grade 1 or 2 neutrophils-cellulitis None Infections and infestations None View
Insomnia None Psychiatric disorders None View
Leukocytes (total WBC) None Blood and lymphatic system disorders None View
Memory impairment None Nervous system disorders None View
Metabolic/laboratory-Other None Metabolism and nutrition disorders None View
Mood alteration-agitation None Psychiatric disorders None View
Mood alteration-anxiety None Psychiatric disorders None View
Mood alteration-depression None Psychiatric disorders None View
Mucositis/stomatitis-anus/rectum (functional/symptomatic) None Gastrointestinal disorders None View
Mucositis/stomatitis-oral cavity (clinical exam) None Gastrointestinal disorders None View
Muscle weakness, generalized or specific area-upper extremity/whole body/generalized None Musculoskeletal and connective tissue disorders None View
Musculoskeletal/soft tissue-Other None Musculoskeletal and connective tissue disorders None View
Nail changes None Skin and subcutaneous tissue disorders None View
Neuropathy - sensory None Nervous system disorders None View
Obesity None Metabolism and nutrition disorders None View
Ocular/visual-Other None Eye disorders None View
Otitis, middle ear (non-infectious) None Ear and labyrinth disorders None View
Pain-abdomen NOS None General disorders None View
Pain-anus/rectum None General disorders None View
Pain-back None General disorders None View
Pain-bone None General disorders None View
Pain-chest/thorax None General disorders None View
Pain-dental/periodontal None General disorders None View
Pain-Head/headache None Nervous system disorders None View
Pain-joint None Musculoskeletal and connective tissue disorders None View
Pain-oral cavity/gums None General disorders None View
Pain-Other/NOS None General disorders None View
Pain-pelvis None General disorders None View
Pain-sinus None General disorders None View
Pain-stomach None Gastrointestinal disorders None View
Pain-throat, pharynx None Respiratory, thoracic and mediastinal disorders None View
Platelets None Investigations None View
Pruritis None Skin and subcutaneous tissue disorders None View
Pulmonary\upper respiratory-Other None Respiratory, thoracic and mediastinal disorders None View
Rash/desquamation None Skin and subcutaneous tissue disorders None View
Rash acne/actiform None Skin and subcutaneous tissue disorders None View
palmar/plantar paresthesia None Skin and subcutaneous tissue disorders None View
Renal/Genitourinary-Other None Renal and urinary disorders None View
Rigor, chills None General disorders None View
Sweating/diphoresis None Skin and subcutaneous tissue disorders None View
Syncope/fainting None Nervous system disorders None View
Taste alteration (dysgeusia) None Nervous system disorders None View
Thyroid function, low (hypothyroidism) None Endocrine disorders None View
Uric acid, serum-high (hyperuricemia) None Renal and urinary disorders None View
Urinary frequency/urgency None Renal and urinary disorders None View
Vascular-other None Vascular disorders None View
Vision-blurred vision None Eye disorders None View
Vision-flashing lights/floaters None Eye disorders None View
Voice changes/dysarthria None Respiratory, thoracic and mediastinal disorders None View
Vomiting None Gastrointestinal disorders None View
Weight loss None Investigations None View
Alkaline phosphatase None Investigations None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Arthritis (non-septic) None Musculoskeletal and connective tissue disorders None View
Bicarbonate, serum-low None Investigations None View
Hyperbilirubinemia None Investigations None View
Burn None Injury, poisoning and procedural complications None View
Chelitis None Gastrointestinal disorders None View
Endocrine other None Endocrine disorders None View
Extrapyramidal/involuntary movement/restlessnes None Nervous system disorders None View
Hemoglobinuria None Renal and urinary disorders None View
Hiccoughs None Respiratory, thoracic and mediastinal disorders None View
Hyperpigmentation None Skin and subcutaneous tissue disorders None View
Infection with unknown ANC-cellulitis None Infections and infestations None View
Infection with unknown ANC-soft tissue None Infections and infestations None View
Pain-breast None Reproductive system and breast disorders None View
Pain-extremity. limb None Musculoskeletal and connective tissue disorders None View
Pain-buttock None Musculoskeletal and connective tissue disorders None View
Pain-muscle None Musculoskeletal and connective tissue disorders None View
Watery eye (epiphora, tearing) None Eye disorders None View
Weight gain None Metabolism and nutrition disorders None View
Confusion None Psychiatric disorders None View
Hypotension None Vascular disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils-external ear None Ear and labyrinth disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils-Eye NOS None Eye disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils-lung (pneumonia) None Respiratory, thoracic and mediastinal disorders None View
Infection with unknown ANC-stomach None Gastrointestinal disorders None View
Infection with unknown ANC-wound None Infections and infestations None View
Leak (including anastomatic)-GI-rectum None Gastrointestinal disorders None View
Left ventricular systolic dysfunction None Cardiac disorders None View
Occular surface disease None Eye disorders None View
Partial prothrombin time (PTT) None Investigations None View
Seizure None Nervous system disorders None View
Supraventricular and nodal arrhythmia-atrial tachycardia/paroxysmal atrial tachycardia None Cardiac disorders None View
Telangiectasia None Skin and subcutaneous tissue disorders None View
Mucositis/stomatitis (functional/symptomatic)-Oral cavity None Infections and infestations None View
Myositis None Musculoskeletal and connective tissue disorders None View
pneumonitis/pumonary infiltrates None Respiratory, thoracic and mediastinal disorders None View
Vessel injury-vein-extremity-limb None Vascular disorders None View
Nausea None Gastrointestinal disorders None View
Neurology-Other None Nervous system disorders None View
Proteinuria None Renal and urinary disorders None View
Pain-neck None General disorders None View
Pain-skin None Skin and subcutaneous tissue disorders None View
Palpitations None Cardiac disorders None View
Hypophosphatemia None Investigations None View
Pain-scalp None Skin and subcutaneous tissue disorders None View
Tumor pain None General disorders None View
Triglyceride, serum-high None Investigations None View
Infection with normal ANC or Grade 1 or 2 neutrophils-sinus None Infections and infestations None View
Infection with normal ANC or Grade 1 or 2 neutrophils-upper airway NOS None Respiratory, thoracic and mediastinal disorders None View
Pain-chest wall None General disorders None View
Lymphopenia None Blood and lymphatic system disorders None View