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 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
NCT ID:
NCT00586105
Description:
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Frequency Threshold:
5
Time Frame:
From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Study:
NCT00586105
Study Brief:
Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)
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 (Nexavar, BAY43-9006) | 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID) | None | None | 12 | 39 | 39 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Pain, Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Infection With Normal ANC, Paranasal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 3.0 | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | View |
| Hemorrhage, GI, Duodenum | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 3.0 | View |
| Hemorrhage, GU, Urinary NOS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 3.0 | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 3.0 | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 3.0 | View |
| Obstruction, GI, Small Bowel NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| No Code In CTCAE | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Infection With Normal ANC, Biliary Tree | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 3.0 | View |
| Infection With Normal ANC, Urinary Tract NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 3.0 | View |
| Infection With Unknown ANC, Skin (Cellulitis) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 3.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 3.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 3.0 | View |
| Pulmonary - Other | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | View |
| Hand-Foot Skin Reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | View |
| Hemorrhage - Other | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 3.0 | View |
| Hemorrhage Pulmonary, Bronchus | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 3.0 | View |
| PTT | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 3.0 | View |
| Edema: Limb | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 3.0 | View |
| Supraventricular Arrhythmia, Sinus Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 3.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 3.0 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | NCI CTC 3.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Mucositis (Functional/Symptomatic), Oral Cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Mucositis (Clinical Exam), Oral Cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| GI - Other | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Periodontal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 3.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Weight Gain | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Weight Loss | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Back | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Chest/Thorax NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Chest Wall | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Dental/Teeth/Peridontal | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Extremity - Limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Head/Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Joint | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Bone | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Pain, Stomach | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Flu-Like Syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 3.0 | View |
| Infection With Normal ANC, Urinary Tract NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 3.0 | View |
| Infection - Other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 3.0 | View |
| Infection With Unknown ANC, Skin (Cellulitis) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 3.0 | View |
| Alkaline Phosphatase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| ALT | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Amylase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| AST | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Bilirubin (Hyperbilirubinemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Hyperuricemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Lipase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Metabolic/Lab - Other | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 3.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 3.0 | View |
| Incontinence, Urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTC 3.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | View |
| Nasal/Paranasal Reactions | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | View |
| Dyspnea (Shortness Of Breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | View |
| Voice Changes | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | View |
| Hand-Foot Skin Reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | View |
| Rash/Desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | View |