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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
NCT ID:
NCT01723202
Description:
None
Frequency Threshold:
5
Time Frame:
The severity of adverse events will be graded utilizing the National Cancer Institutes Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) up to 1 year. All-Cause Mortality was assessed up to 5 years.
Study:
NCT01723202
Study Brief:
Dabrafenib With or Without Trametinib in Treating Patients With Advanced Differentiated Thyroid Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm B: Dabrafenib + Trametinib | Patients receive dabrafenib orally twice a day and trametinib orally once a day on days 1-28. dabrafenib: 150 mg orally twice daily given orally trametinib: 150 mg orally twice daily and GSK1120212 (MEKi) 2 mg orally once daily given orally Correlative Studies: 1. Signaling inhibition studies in tumor biopsies (10 pts in each arm; 5 pts per center) 2. BRAF mutation studies in circulating plasma DNA (all study patients) 3. Mechanisms of drug resistance in tumor biopsies or tumor blocks (5 pts in each arm) 4. Assess predictors of response (Archival tumor block/unstained slides in all study patients) 5. Pharmacokinetic studies (First 10 pts enrolled on each arm) 6. Pharmacogenomics studies (All study patients) | 8 | None | 6 | 27 | 27 | 27 | View |
| Crossover to Dabrafenib + Trametinib | Patients receive dabrafenib orally twice a day and trametinib orally once a day on days 1-28. dabrafenib: 150 mg orally twice daily given orally trametinib: 150 mg orally twice daily and GSK1120212 (MEKi) 2 mg orally once daily given orally | 2 | None | 0 | 14 | 14 | 14 | View |
| Arm A: Dabrafenib Alone | Patients receive dabrafenib orally 2 twice a day on days 1-28. Patients with disease progression may cross over to arm II. dabrafenib: 150 mg orally twice daily given orally Correlative Studies: 1. Signaling inhibition studies in tumor biopsies (10 pts in each arm; 5 pts per center) 2. BRAF mutation studies in circulating plasma DNA (all study patients) 3. Mechanisms of drug resistance in tumor biopsies or tumor blocks (5 pts in each arm) 4. Assess predictors of response (Archival tumor block/unstained slides in all study patients) 5. Pharmacokinetic studies (First 10 pts enrolled on each arm) 6. Pharmacogenomics studies (All study patients) | 9 | None | 6 | 26 | 26 | 26 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Gastric Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Nausea | 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 |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Papillary urothelial carcinoma of the bladder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Cardiac disorders - Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Retinal vascular disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Colonic hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Duodenal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric 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 |
| Blood and lymphatic system disorders - Other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac 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 |
| Endocrine disorders - Other | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v4.0 | View |
| Hypothyrodism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v4.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Lymphocyte count decreased | 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 |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Musculoskeletal and connective tissue disorder - Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Myalgia | 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 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Nervous system disorders - Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Renal and urinary disorders - Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary 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 |
| Hoarseness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Laryngeal hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Pleural effusion | 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 | 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 |
| 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 maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Skin and subcutaneous tissue disorders - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Hot flashes | 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 |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Vascular disorders, other | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Cardiac Disorders- other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Papulopustular rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Injury, poisoning and procedural complications - Other | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Cholesterol high | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Surgical and medical procedures - Other | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE v4.0 | View |
| Thrombotic thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Left ventricular systolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Ventricular arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Ear and labyrinth disorders - Other | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Hepatobiliary disorders - Other | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v4.0 | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Joint range of motion decreased | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Concentration impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Psychiatric disorders - Other | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Sinus disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Nail ridging | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue 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 |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypertriglyceridemia | 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 |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypokalemia | 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 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue 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 |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Gastrointestinal disorders - Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Pancreatitis | 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 limbs | 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 |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| General disorders and administration site conditions - Other | 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 |
| Infections and infestations - Other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 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 |
| Investigations - Other | 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 |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Eye disorders - Other | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |