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 @ 3:52 PM
Ignite Modification Date:
2025-12-25 @ 1:58 PM
NCT ID:
NCT00831792
Description:
None
Frequency Threshold:
0
Time Frame:
From the time of enrollment until 30 days beyond the date of the last study drug administration
Study:
NCT00831792
Study Brief:
TKI258 in Castrate Resistant Prostate 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 |
|---|---|---|---|---|---|---|---|---|
| All Patients Enrolled and Treated With TKI 258 | Patients with castrate-resistant prostate cancer | 0 | None | 2 | 40 | 40 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Muscle weakness, generalized or specific area (not due to neuropathy): Extremity - lower | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | View |
| Infection with unknown ANC--Select: Urinary tract NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 2.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils--Select: Skin (cellulitis) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Allergy/Immunology-Other (Specify) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE 2.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE 2.0 | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 2.0 | View |
| Amylase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 2.0 | View |
| Ataxia (incoordination) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Atrophy, skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 2.0 | View |
| Autoimmune reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE 2.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 2.0 | View |
| Bladder spasms | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 2.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Bronchospasm, wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 2.0 | View |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Calcium, serum-low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Cholesterol, serum-high (hypercholestremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 2.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Cystitis noninfective | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 2.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 2.0 | View |
| Dermatology/Skin-Other (Specify) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 2.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| DIC (disseminated intravascular coagulation) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Dry mouth/salivary gland (xerostomia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 2.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 2.0 | View |
| Dysesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 2.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Edema trunk | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Edema: trunk/genital | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9 per liter) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 2.0 | View |
| fibrinogen | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 2.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Gastrointestinal-Other (Specity) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 2.0 | View |
| GGT (gamma-Glutamyl transpeptidase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 2.0 | View |
| Glucose, serum-low (hypoglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Heartburn/dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 2.0 | View |
| Hemoglobinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 2.0 | View |
| Hemorrhage, GU--Select (Urinary NOS) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 2.0 | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE 2.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Hypertension (Adult) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 2.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 2.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils--Select (Urinary tract NOS) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 2.0 | View |
| Infection (clinically or microbiologically) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 2.0 | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 2.0 | View |
| Infection-Other (Specify) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 2.0 | View |
| INR (International Normalized Ratio of prothrombin time) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Leukocytes (Total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 2.0 | View |
| Lipase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 2.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 2.0 | View |
| Magnesium, serum-low (hypomagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Mood alteration-depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 2.0 | View |
| Mood alteration--Select | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 2.0 | View |
| Mood alteration--Select (Depression) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 2.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Mucositis/stomatitis (clinical exam) (Oral Cavity) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity - lower) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) (Whole body/generalized) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Neurology-Other (Specify) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Neuropathy: sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 2.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain-Other (Specify) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Abdomen NOS) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Back) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Bone) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Buttock) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Cardiac/heart) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Chest wall) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Dental/teeth/peridontal) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Extremity-limb) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Head/headache) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Joint) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Liver) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Pain NOS) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Pelvis) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Rectum) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Scalp) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pain--Select (Throat/pharynx/larynx) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pancreatic endocrine: glucose intolerance | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE 2.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Pericardial effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 2.0 | View |
| Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Potassium serum-high (hyperkalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| PTT (Partial Thromboplastin Time) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 2.0 | View |
| Pulmonary/Upper Respiratory-Other (Specify) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 2.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 2.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 2.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 2.0 | View |
| Renal and urinary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 2.0 | View |
| Rigors, chills | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 2.0 | View |
| Salivary gland changes/saliva | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Skin hypopigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 2.0 | View |
| Sodium, serum-high (hypernatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Supraventricular and nodal arrhythmia--Select (Atrial fibrillation) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Supraventricular and nodal arrhythmia--Select (Atrial flutter) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Supraventricular and nodal arrhythmia--Select (Sinus tachycardia) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 2.0 | View |
| Syncope (fainting) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 2.0 | View |
| Taste alteration (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Thrombosis/embolism (vascular access-related) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 2.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 2.0 | View |
| Triglyceride, serum-high (hypertriglyceridemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Uric acid, serum-high (hyperuricemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 2.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 2.0 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 2.0 | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 2.0 | View |
| Urine color change | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 2.0 | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 2.0 | View |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 2.0 | View |
| Watery eye (epiphora, tearing) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE 2.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 2.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 2.0 | View |