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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT00496756
Description: None
Frequency Threshold: 5
Time Frame: Adverse events and serious adverse events will be collected and reported on the forms beginning with the first dose of investigational product and continuing through the end of the study. (approximately 4 months)
Study: NCT00496756
Study Brief: Sorafenib in Treating Patients With Metastatic or Unresectable 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
Sorafenib The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol. Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d. A treatment cycle will be 4 weeks. Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol. 6 None 2 14 11 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other, weakness SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other, shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other, extremities tingling, numbness SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other- rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other, pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other, hand foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other, upset stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other, mouth sensitivity SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Other, elevated cardiac enzymes SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Other, stomach cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Other, cramping SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other, DVT SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other, increased alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Other, blood in stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other, weak urine stream SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Other, pale face SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Other, Bleeding gums SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Other, hematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Other, pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other, soreness mouth and throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Other, Blisters SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other, pulmonary embolus SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Other, renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Other, tingling hands SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other, lesions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other, swelling SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other, Weakness SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other, cracking, erythema fingertips SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other, Hematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other, Soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Other, Tenderness/burning scalp SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other, Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Other, Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Other, Stomatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hematuria (trace) SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Other, decreased ionized calcium level SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Other, decreased magnesium level SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Other, Leukoplakia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View