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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
NCT ID:
NCT00110994
Description:
Abbreviations used in the Adverse Events section: Absolute Neutrophil Count (ANC), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Central Nervous System (CNS), Common Terminology Criteria for Adverse Events (CTCAE), Gastro-Intestinal (GI), National Cancer Institute (NCI), Not Otherwise Specified (NOS)
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00110994
Study Brief:
Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
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) + Dacarbazine | Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. | None | None | 22 | 51 | 49 | 51 | View |
| Placebo + Dacarbazine | Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. | None | None | 14 | 50 | 45 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| platelets | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| neutrophils | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| leukocytes | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| supraventricular arrhythmia, atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v.3.0 | View |
| supraventricular arrhythmia, supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v.3.0 | View |
| hypotension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v.3.0 | View |
| cardiac ischemia / infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v.3.0 | View |
| cardiopulmonary arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v.3.0 | View |
| hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v.3.0 | View |
| death not associated with CTCAE term, disease progression NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| death not associated with CTCAE term, multi-organ failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| constitutional symptoms - other | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| rigors / chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| CNS hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTCAE v.3.0 | View |
| hemorrhage, GI, abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTCAE v.3.0 | View |
| hemorrhage, GI, upper GI NOS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTCAE v.3.0 | View |
| hemorrhage - other | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTCAE v.3.0 | View |
| hemorrhage pulmonary, nose | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTCAE v.3.0 | View |
| cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI-CTCAE v.3.0 | View |
| liver dysfunction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI-CTCAE v.3.0 | View |
| pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI-CTCAE v.3.0 | View |
| infection - other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTCAE v.3.0 | View |
| infection with unknown ANC, skin (cellulitis) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTCAE v.3.0 | View |
| fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | View |
| CNS ischemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v.3.0 | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v.3.0 | View |
| neurology - other | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v.3.0 | View |
| psychosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v.3.0 | View |
| seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v.3.0 | View |
| blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | NCI-CTCAE v.3.0 | View |
| pain, chest / thorax NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, extremity - limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, head / headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, muscle | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, pain NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | View |
| renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI-CTCAE v.3.0 | View |
| renal - other | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI-CTCAE v.3.0 | View |
| thrombosis / thrombus / embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTCAE v.3.0 | View |
| no code in CTCAE | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| allergic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | NCI-CTCAE v.3.0 | View |
| platelets | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| neutrophils | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| leukocytes | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v.3.0 | View |
| hypotension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v.3.0 | View |
| fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| weight loss | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| rigors / chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| sweating | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| hand-foot skin reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | View |
| alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | View |
| injection site reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | View |
| dermatology - other | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | View |
| flushing | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | View |
| dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | View |
| acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| heartburn | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| GI - other | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| taste alteration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| mucositis (functional / symptomatic), oral cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v.3.0 | View |
| edema: limb | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | View |
| lipase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | View |
| ALT | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | View |
| amylase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | View |
| AST | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | View |
| hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | View |
| hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | View |
| metabolic / lab - other | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | View |
| hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | View |
| neuropathy: sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v.3.0 | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v.3.0 | View |
| pain, head / headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, joint | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, muscle | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, extremity - limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, pain NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| pain, other | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v.3.0 | View |
| voice changes | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | View |
| rash / desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | View |
| pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | View |