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:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT00044512
Description:
Acronyms in Adverse Event section: Gastrointestinal (GI), Central Nervous System (CNS), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Gamma Glutamyl Transpeptidase (GGT), Acute Respiratory Distress Syndrome (ARDS), Without grade 3 or 4 (W/O GR 3 or 4), Neutropenia (Neu)
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00044512
Study Brief:
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
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 400 mg b.i.d. | Sorafenib (Nexavar, BAY43-9006) 400 mg administered b.i.d."Other AE" section includes SAEs | None | None | 77 | 137 | 126 | 137 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutrophils | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 2.0 | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 2.0 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 2.0 | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 2.0 | View |
| Supraventricular Arrythmia, Sinus Bradicardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 2.0 | View |
| Supraventricular Arrythmia, Supraventricular Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 2.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 2.0 | View |
| Cardiac Ischemia / Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 2.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 2.0 | View |
| Cardiac General - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 2.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Constitutional Symptoms - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| GI - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Hypercreatininemia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTC 2.0 | View |
| Renal Failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTC 2.0 | View |
| Genito-Urinary - Other | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTC 2.0 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTC 2.0 | View |
| Urinary Retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTC 2.0 | View |
| CNS Hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 2.0 | View |
| Melena / GI Bleeding | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 2.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 2.0 | View |
| Hemorrhage with Surgery | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 2.0 | View |
| Hemorrhage - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 2.0 | View |
| Rectal Bleeding | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 2.0 | View |
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 2.0 | View |
| Hematemesis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 2.0 | View |
| Hemorrhage / Bleeding W/O GR 3 or GR 4 Thrombo | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC 2.0 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Alkaline Phospharase | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| AST | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| Hyperbilirubinemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| Liver Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| GGT increase | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| Hepatobiliary - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| Infection W/GR 3 or GR 4 Neu | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 2.0 | View |
| Infection without Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 2.0 | View |
| Infection - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 2.0 | View |
| Lymphatics - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 2.0 | View |
| Musculoskeletal - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | View |
| Amylase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| Lipase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| CNS Ischemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 2.0 | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 2.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 2.0 | View |
| Memory Impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 2.0 | View |
| Neurology - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 2.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 2.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 2.0 | View |
| Syncope (Fainting) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 2.0 | View |
| Glaucoma | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTC 2.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Pain, Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Pain - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| ARDS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Pulmonary - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Dyspnea (Shortness of Breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Head-Foot Skin Reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | View |
| Wound Complication, non-infectious | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | View |
| Dermatology - Other (Specify) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | View |
| Rash/Desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| AST | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| Bilirubin (Hyperbilirubinemia) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| Pain, Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Pain, Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Hand-Foot Skin Reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | View |
| Rash/Desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 2.0 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 2.0 | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC 2.0 | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 2.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC 2.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Weight Loss | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| GI-Other | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Mucositis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC 2.0 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| Alkaline Phosphatase | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| ALT | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| GGT | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| Hepatobiliary-Other | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC 2.0 | View |
| Infection Without Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC 2.0 | View |
| Amylase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| Lipase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| Metabolic/Lab-Other | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC 2.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC 2.0 | View |
| Pain, Head/Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Pain, Muscle | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC 2.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Pulmonary-Other | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Dyspnea (Shortness of Breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Voice Changes | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | View |
| Dermatology-Other | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | View |