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 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
NCT ID:
NCT01601535
Description:
None
Frequency Threshold:
5
Time Frame:
From date of study enrollment to the date of progression or withdrawal from the study, up to 34 cycles (about 2 years).
Study:
NCT01601535
Study Brief:
Study of MLN8237 in Combination With Irinotecan and Temozolomide
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DL 1 | alisertib tablets (45 mg/m\^2/dose x 7 days), irinotecan (50 mg/m\^2/dose IV x 5 days), temozolomide (100 mg/m\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional | 0 | None | 3 | 6 | 6 | 6 | View |
| DL 1B | alisertib tablets (45 mg/m\^2/dose x 7 days), irinotecan (50 mg/m\^2/dose IV x 5 days), temozolomide (100 mg/m\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required | 0 | None | 3 | 6 | 6 | 6 | View |
| DL 2B | alisertib tablets (60 mg/m\^2/dose x 7 days), irinotecan (50 mg/m\^2/dose IV x 5 days), temozolomide (100 mg/m\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required | 0 | None | 3 | 6 | 6 | 6 | View |
| DL 3B | alisertib tablets (80 mg/m\^2/dose x 7 days), irinotecan (50 mg/m\^2/dose IV x 5 days), temozolomide (100 mg/m\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required | 0 | None | 2 | 4 | 4 | 4 | View |
| Ph 2 | alisertib tablets (60 mg/m\^2/dose x 7 days), irinotecan (50 mg/m\^2/dose IV x 5 days), temozolomide (100 mg/m\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required | 0 | None | 1 | 20 | 20 | 20 | View |
| Oral Solution | alisertib oral solution (45 mg/m\^2/dose x 7 days), irinotecan (50 mg/m\^2/dose IV x 5 days), temozolomide (100 mg/m\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required | 0 | None | 2 | 12 | 12 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Movements involuntary | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Pharyngeal mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Hemolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v4.0 | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Eye disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Anal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Gastrointestinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Oral dysesthesia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Oral hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Rectal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Rectal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Stomach pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Edema trunk | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Conjunctivitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Mucosal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Rhinitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Electrocardiogram QT corrected interval prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Hemoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Investigations - Other, specify | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Lymphocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Metabolism and nutrition disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Musculoskeletal and connective tissue disorder - Other, specify | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Nervous system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Hallucinations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Psychiatric disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Urine discoloration | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Penile pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v4.0 | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Apnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Pharyngeal mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Pharyngolaryngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Postnasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Bullous dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Palmar-plantar erythrodysesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Skin and subcutaneous tissue disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Surgical and medical procedures - Other, specify | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE v4.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |