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 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:59 PM
NCT ID:
NCT00134056
Description:
Participants were monitored for toxicity every 3 weeks while on protocol therapy or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Frequency Threshold:
5
Time Frame:
Assessed every 3 weeks up to 52 weeks
Study:
NCT00134056
Study Brief:
S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm I: Placebo | Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks. | None | None | 172 | 486 | 476 | 486 | View |
| Arm II: Atrasentan | Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks. | None | None | 153 | 492 | 475 | 492 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Stricture/stenosis (including anastomotic), GI - A | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Skin | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | 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 |
| Magnesium, serum-high (hypermagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Hemorrhage, CNS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Induration/fibrosis (skin and subcutaneous tissue) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pain - Scalp | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Thrombosis/thrombus/embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| DIC (disseminated intravascular coagulation) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Cardiac General-Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Cardiac-ischemia/infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Cardiopulmonary arrest, cause unknown (non-fatal) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Left ventricular diastolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Left ventricular systolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Right ventricular dysfunction (cor pulmonale) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| SVT and nodal arrhythmia - Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| SVT and nodal arrhythmia - Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| SVT and nodal arrhythmia - Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Ventricular arrhythmia - PVCs | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Ventricular arrhythmia - Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Ventricular arrhythmia - Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Otitis, middle ear (non-infectious) | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Distention/bloating, abdominal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry mouth/salivary gland (xerostomia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dysphagia (difficulty swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal-Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Abdomen NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Colon | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Duodenum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Lower GI NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Rectum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Stomach | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Upper GI NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Ileus, GI (functional obstruction of bowel) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam) - Esophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam) - Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Obstruction, GI - Colon | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Obstruction, GI - Small bowel NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Abdomen NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Perforation, GI - Colon | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Perforation, GI - Duodenum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Perforation, GI - Small bowel NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Ulcer, GI - Duodenum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Ulcer, GI - Rectum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Ulcer, GI - Stomach | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Death - Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Death not associated with CTCAE term - Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Edema: head and neck | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Chest/thorax NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Pain NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain-Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Appendix | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Bladder | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Colon | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Lung | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Nerve-periph | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Nose | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - UTI | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Bladder | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Catheter | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Colon | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Liver | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Mid ear | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Muscle | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Scrotum | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Trachea | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - UTI | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils - Wound | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-peri | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/unknown ANC - Middle ear (otitis media) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf w/unknown ANC - Upper aerodigestive NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection (documented clinically or microbiologica | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with unknown ANC - Blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with unknown ANC - Lung (pneumonia) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with unknown ANC - Rectum | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with unknown ANC - Upper airway NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with unknown ANC - Urinary tract NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with unknown ANC - Wound | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection-Other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Perforation, GI - Appendix | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| Thrombosis/embolism (vascular access-related) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| CPK (creatine phosphokinase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Cardiac troponin I (cTnI) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Cardiac troponin T (cTnT) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Fibrinogen | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| INR (of prothrombin time) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Metabolic/Laboratory-Other | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Prolonged QTc interval | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Acidosis (metabolic or respiratory) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Calcium, serum-low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Phosphate, serum-low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition 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 |
| Sodium, serum-low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Joint-effusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle weakness, not d/t neuropathy - Extrem-lower | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle weakness, not d/t neuropathy - body/general | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Musculoskeletal/Soft Tissue-Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Osteonecrosis (avascular necrosis) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Chest wall | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Extremity-limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue 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 |
| Death - Disease progression NOS | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| Pain - Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| CNS cerebrovascular ischemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mental status | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neurology-Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: CN III Pupil, eyelid, xtra ocular mvmt | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: CN VII Motor-face; Sensory-taste | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: cranial - CN VI Lateral deviation of e | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain - Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Somnolence/depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Speech impairment (e.g., dysphasia or aphasia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Syncope (fainting) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Vasovagal episode | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Mood alteration - depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Personality/behavioral | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Psychosis (hallucinations/delusions) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Hemorrhage, GU - Bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Hemorrhage, GU - Urinary NOS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Obstruction, GU - Ureter | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Obstruction, GU - Urethra | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Renal/Genitourinary-Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Urinary retention (including neurogenic bladder) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Pain - Testicle | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Adult respiratory distress syndrome (ARDS) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Edema, larynx | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hemorrhage, Respiratory tract NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hemorrhage, pulmonary/upper respiratory - Lung | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pneumonitis/pulmonary infiltrates | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pulmonary fibrosis (radiographic changes) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dermatology/Skin-Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pain-Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Bruising (in absence of Gr 3-4 thrombocytopenia) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Watery eye (epiphora, tearing) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry mouth/salivary gland (xerostomia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Heartburn/dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam) - Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (functional/symp) - Oral cav | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Abdomen NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Metabolic/Laboratory-Other | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Calcium, serum-low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Glucose, serum-high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition 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 |
| Sodium, serum-low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Muscle weakness, not d/t neuropathy - body/general | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Extremity-limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue 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 |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain - Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Mood alteration - anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Mood alteration - depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | 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 |
| Nasal cavity/paranasal sinus reactions | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hair loss/Alopecia (scalp or body) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hot flashes/flushes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |