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 @ 2:47 PM
Ignite Modification Date:
2025-12-25 @ 1:16 PM
NCT ID:
NCT03128359
Description:
None
Frequency Threshold:
0
Time Frame:
Up to 2 years post-transplant.
Study:
NCT03128359
Study Brief:
High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis) | Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV | 9 | None | 12 | 19 | 19 | 19 | View |
| Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis) | Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI | 0 | None | 6 | 19 | 19 | 19 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| HEMOLYSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| DIARRHEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| FEVER | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| CMV VIREMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| ENTEROBACTER BACTEREMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| NOCARDIA INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| DISEASE RELAPSE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.03) | View |
| RELAPSED DISEASE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.03) | View |
| ADULT RESPIRATORY DISTRESS SYNDROME | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| DYSPNEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| HEMOLYSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| HEMOLYTIC UREMIC SYNDROME | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| LEFT NECK NODULE | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| LEUKOCYTOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| LYMPH NODE PAIN | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| ATRIAL FLUTTER | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| CARDIOMEGALY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| CHEST PAIN CARDIAC | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| GR DIASTOLIC DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| HEART FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| PAROXYSMAL ATRIAL TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| RIGHT VENTRICULAR DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| SINUS BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| SR WITH PVCS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| SUPRAVENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| EAR PAIN | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.03) | View |
| TINNITUS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.03) | View |
| ADRENAL HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (4.03) | View |
| BLURRED VISION | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.03) | View |
| CONJUNCTIVAL HEMORRHAGE | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.03) | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.03) | View |
| FLASHING LIGHTS | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.03) | View |
| FLOATERS | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.03) | View |
| RT EYE IRRITATION | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.03) | View |
| SUBCONJUNCTIVAL HEMORRHAGE | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.03) | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| ANAL HEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| ANAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| ASCITES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| BLOATING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| CHEILITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| DENTAL CARIES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| DIARRHEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| DUODENAL HEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| FECAL INCONTINENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| GASTROESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| GASTROPARESIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| GINGIVAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| HEMORRHOIDAL HEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| HEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| ILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| LOWER GASTROINTESTINAL HEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| MUCOSITIS ORAL | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| ORAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| PERIANAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| RECTAL HEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| RECTAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| SALIVARY DUCT INFLAMMATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| SMALL INTESTINAL MUCOSITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| EDEMA FACE | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| EDEMA LIMBS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| FEVER | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| GAIT DISTURBANCE | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| HYPOTHERMIA | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| INJECTION SITE REACTION | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| IRRITABILITY | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| LOCALIZED EDEMA | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| NONCARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.03) | View |
| HEPATOMEGALY | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.03) | View |
| ALLERGIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.03) | View |
| CYTOKINE RELEASE SYNDROME | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.03) | View |
| ADENOVIRUS VIREMA | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| BLADDER INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| CATHETER RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| CITROBACTER FREUNDII BACTEREMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| CMV | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| CMV REACTIVATION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| CMV VIREMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| CORONAVIRUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| E COLI BACTEREMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| ENTEROCOCCUS FAECALIS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| ENTEROCOLITIS INFECTIOUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| HERPES SIMPLEX | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| HERPES VIRUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| KLEBSIELLA PNEUMONIAIE | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| LUNG INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| NAIL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| POSITIVE CMV PCR | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| S. VIRIDANS BACTEREMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| STEM CELL PRODUCT GRAM POSITIVE | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| VAGINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| VIRIDANS STREPTOCOCCI BACTEREMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| BRUISING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.03) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.03) | View |
| LIP LESION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.03) | View |
| SKIN EXCORIATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.03) | View |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| CARDIAC TROPONIN I INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| LYMPHOCYTE COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| WEIGHT GAIN | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| WEIGHT LOSS | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| WHITE BLOOD CELL DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| ALKALOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPERCALCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPERGLYCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPERKALEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPERMAGNESEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPERNATREMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPERTRIGLYCERIDEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPERURICEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPOALBUMINEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPOCALCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPOGLYCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPOKALEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPOMAGNESEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPONATREMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| HYPOPHOSPHATEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| OBESITY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| CHEST WALL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| DYSTONIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| GENERALIZED MUSCLE WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| HIP PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| MYOCLONIC JERKS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | View |
| FOCAL INTRAMUCOSAL ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.03) | View |
| AMNESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| COGNITIVE DISTURBANCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| CONCENTRATION IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| DEPRESSED LEVEL OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| DYSPHASIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| HYPERSOMNIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| MEMORY IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| PARESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| PRESYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.03) | View |
| AGGRAVATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| AGITATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| CONFUSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| HALLUCINATIONS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| RESTLESSNESS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.03) | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| ACUTE RENAL INSUFFICIENCY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| BLADDER SPASM | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| BPH | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| CYSTITIS NONINFECTIVE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| HEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| PROTEINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| URINARY FREQUENCY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| URINARY TRACT PAIN | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| URINARY URGENCY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.03) | View |
| GENITAL EDEMA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| MENORRHAGIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| PELVIC PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| PENILE PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| SCROTAL EDEMA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| SCROTAL PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| VAGINAL DISCHARGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| VAGINAL DRYNESS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| VAGINAL HEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| VAGINAL ITCH | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| VAGINAL PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| VAGINAL SORES | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.03) | View |
| ALLERGIC RHINITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| ASPIRATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| DYSPNEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| HICCUPS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| LUNG CRACKLES | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| POSTNASAL DRIP | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| PULMONARY EDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| PULOMONARY NODULES | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| SENSITIVITY TO SMELL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| SLEEP APNEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| SNEEZING | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| SORE THROAT | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| VOICE ALTERATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| WHEEZING | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| ALLERGIC DERMITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| BULLOUS DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| ERYTHEMA TOE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| FOLLICULAR SKIN LESIONS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| HICKMAN CATHETER EXIT SITE REDNESS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| HICKMAN SITE INFLAMMATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| L ANKLE LACERATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| L THIGH TUMOR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| LEFT TOE INFLAMMATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| PALLOR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| PALMARPLANTAR ERYTHRODYSESTHESIA SYNDROME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| PERIORBITAL EDEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| RASH ACNEIFORM | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| RASH MACULOPAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| RED SPOTS ON CALVES | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| SCALP PAIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| SKIN ABRASION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| SKIN HYPERPIGMENTATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| SKIN ULCERATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| URTICARIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| FLUSHING | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.03) | View |
| HEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.03) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.03) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.03) | View |
| SUPERFICIAL THROMBOPHLEBITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.03) | View |
| VASCULAR CONGESTION | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.03) | View |