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 @ 5:37 PM
Ignite Modification Date:
2025-12-25 @ 3:08 PM
NCT ID:
NCT00126568
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
Study:
NCT00126568
Study Brief:
Sorafenib in Treating Patients With Advanced Anaplastic Thyroid 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 |
|---|---|---|---|---|---|---|---|---|
| BAY 43-9006 | BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month). | None | None | 8 | 20 | 20 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death not associated with CTCAE term - Death NOS(not otherwise specified) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Death not associated with CTCAE term - Disease progression NOS(not otherwise specified) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Pain - Abdomen NOS(not otherwise specified) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Thrombosis/thrombus/embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Death not associated with CTCAE term - Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Infection with unknown ANC(Absolute neutrophil count) - Lung (pneumonia) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Perforation, GI - Appendix | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pulmonary/Upper Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Speech impairment (e.g., dysphasia or aphasia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Calcium, serum-low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Cardiac ischemia/infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Cardiac troponin I (cTnI) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Cervical spine-range of motion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constitutional Symptoms - Other (Specify, __) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dermatology/Skin - Other (Specify, __) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Distension/bloating, abdominal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry mouth/salivary gland (xerostomia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dysphagia (difficulty swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Edema: head and neck | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fever (in the absence of neutropenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| GGT (gamma-Glutamyl transpeptidase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Glucose, serum-high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Glucose, serum-low (hypoglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hair loss/alopecia (scalp or body) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Lower GI NOS(not otherwise specified) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS(not otherwise specified) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hemorrhage, pulmonary/upper respiratory - Larynx | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hemorrhage, pulmonary/upper respiratory - Nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS(not otherwise specified) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hiccoughs (hiccups, singultus) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| INR (International Normalized Ratio of prothrombin time) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Infection with normal ANC(Absolute Neutrophil Count) or Grade 1 or 2 neutrophils - Pharynx | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC(Absolute Neutrophil) or Grade 1 or 2 neutrophils - Upper aerodigestive NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC(Absolute Neutrophil Count) or Grade 1 or 2 neutrophils - Upper airway NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC(Absolute Neutrophil Count) or Grade 1 or 2 neutrophils - Urinary tract NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC(Absolute Neutrophil Count) or Grade 1 or 2 neutrophils - Vagina | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Leukocytes (total White Blood Count) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Magnesium, serum-high (hypermagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Magnesium, serum-low (hypomagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Mood alteration - Depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam) - Oral cavity | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (functional/symptomatic) - Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Musculoskeletal/Soft Tissue - Other (Specify, __) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neurology - Other (Specify, __) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC(absolute neutrophil count)/AGC(absolute granulocyte count) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Obstruction/stenosis of airway - Trachea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Ocular/Visual - Other (Specify, __) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| PTT (Partial Thromboplastin Time) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Abdomen NOS (not otherwise specified) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Back | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Chest/thorax NOS (not otherwise specified) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Extremity-limb | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Head/headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Joint | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Muscle | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Neck | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Oral cavity | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Pelvis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Scrotum | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Stomach | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Throat/pharynx/larynx | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Tumor pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain-Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Perforation, GI - Appendix | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pericardial effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Phosphate, serum-low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Potassium, serum-high (hyperkalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Potassium, serum-low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Pruritus/itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pulmonary/Upper Respiratory - Other (Specify, __) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: acne/acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: dermatitis associated with radiation - Chemoradiation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: dermatitis associated with radiation - Radiation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Salivary gland changes/saliva | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Secondary Malignancy - possibly related to cancer treatment (Specify, __) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| Skin breakdown/decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Sodium, serum-low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Speech impairment (e.g., dysphasia or aphasia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Stricture/stenosis (including anastomotic), GI - Pharynx | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Supraventricular and nodal arrhythmia - Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Thyroid function, high (hyperthyroidism, thyrotoxicosis) | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Thyroid function, low (hypothyroidism) | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Uric acid, serum-high (hyperuricemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Vision-flashing lights/floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| AST(aspartate aminotransferase), SGOT(serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Arthritis (non-septic) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Bicarbonate, serum-low | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Calcium, serum-high (hypercalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| ALT(Alanine transaminase), SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |