Study: NCT01525966

Adverse event: 10016288-Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10016558-Fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10046571-Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: 10012174-Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10042613-Surgical and medical procedures - Other, specify
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 67 at risk

Adverse event: 10002272-Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 63 affected / 67 at risk

Adverse event: 10016288-Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10007541-Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10019279-Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10033557-Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10040741-Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10040752-Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 67 at risk

Adverse event: 10061589-Aortic valve disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10014020-Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10047340-Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10065838-Middle ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10020705-Hyperparathyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10020850-Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10005886-Blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10010741-Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10013774-Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10015919-Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10015958-Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10016757-Flashing lights
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10016778-Floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10047848-Watering eyes
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10000060-Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10000081-Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 67 at risk

Adverse event: 10005265-Bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10010774-Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 67 at risk

Adverse event: 10012727-Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 67 at risk

Adverse event: 10013781-Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10013946-Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10013950-Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10016766-Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10017947-Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10018286-Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10028130-Mucositis oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: 10028813-Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 67 at risk

Adverse event: 10030980-Oral hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10031009-Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: 10044055-Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10047700-Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 67 at risk

Adverse event: 10066874-Gastroesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: 10008531-Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 67 at risk

Adverse event: 10016256-Fatigue
Serious: no
Organ System: General disorders
Frequency: 64 affected / 67 at risk

Adverse event: 10016558-Fever
Serious: no
Organ System: General disorders
Frequency: 9 affected / 67 at risk

Adverse event: 10017577-Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10022095-Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10033371-Pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 67 at risk

Adverse event: 10050068-Edema limbs
Serious: no
Organ System: General disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10062466-Localized edema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 67 at risk

Adverse event: 10062501-Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 67 at risk

Adverse event: 10001718-Allergic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10002218-Anaphylaxis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10007810-Catheter related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: 10021881-Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 67 at risk

Adverse event: 10040872-Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: 10046300-Upper respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 67 at risk

Adverse event: 10046571-Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 67 at risk

Adverse event: 10055078-Bronchial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: 10061304-Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: 10062255-Soft tissue infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: 10065772-Vulval infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: 10069138-Papulopustular rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: 10006504-Bruising
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 67 at risk

Adverse event: 10016173-Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 67 at risk

Adverse event: 10048031-Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 67 at risk

Adverse event: 10053692-Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 67 at risk

Adverse event: 10061103-Dermatitis radiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 67 at risk

Adverse event: 10001551-Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 67 at risk

Adverse event: 10001675-Alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 67 at risk

Adverse event: 10003481-Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 67 at risk

Adverse event: 10005364-Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 67 at risk

Adverse event: 10007839-CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: 10011368-Creatinine increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 67 at risk

Adverse event: 10025256-Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 67 at risk

Adverse event: 10029366-Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 58 affected / 67 at risk

Adverse event: 10035528-Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 41 affected / 67 at risk

Adverse event: 10047896-Weight gain
Serious: no
Organ System: Investigations
Frequency: 3 affected / 67 at risk

Adverse event: 10047900-Weight loss
Serious: no
Organ System: Investigations
Frequency: 12 affected / 67 at risk

Adverse event: 10049182-White blood cell decreased
Serious: no
Organ System: Investigations
Frequency: 55 affected / 67 at risk

Adverse event: 10050528-Ejection fraction decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: 10002646-Anorexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 67 at risk

Adverse event: 10012174-Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10020587-Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10020639-Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 67 at risk

Adverse event: 10020647-Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10020670-Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10020680-Hypernatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 67 at risk

Adverse event: 10020870-Hypertriglyceridemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 67 at risk

Adverse event: 10020943-Hypoalbuminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 67 at risk

Adverse event: 10020949-Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 67 at risk

Adverse event: 10021005-Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 67 at risk

Adverse event: 10021018-Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 67 at risk

Adverse event: 10021028-Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10021038-Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 67 at risk

Adverse event: 10021059-Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 67 at risk

Adverse event: 10029883-Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10003239-Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10003988-Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 67 at risk

Adverse event: 10006002-Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 67 at risk

Adverse event: 10008496-Chest wall pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10016750-Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10028411-Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 67 at risk

Adverse event: 10028836-Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10031282-Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 67 at risk

Adverse event: 10033425-Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 67 at risk

Adverse event: 10062572-Generalized muscle weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 67 at risk

Adverse event: 10065776-Muscle weakness lower limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10029104-Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 67 at risk

Adverse event: 10045158-Tumor pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 67 at risk

Adverse event: 10013573-Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 67 at risk

Adverse event: 10013911-Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 67 at risk

Adverse event: 10019211-Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 67 at risk

Adverse event: 10027175-Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10029205-Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10029223-Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10033987-Paresthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10034620-Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 67 at risk

Adverse event: 10036653-Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10044565-Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10002855-Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 67 at risk

Adverse event: 10012378-Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 67 at risk

Adverse event: 10022437-Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 67 at risk

Adverse event: 10019450-Hematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10037032-Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10046539-Urinary frequency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 67 at risk

Adverse event: 10046543-Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10046555-Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10046593-Urinary urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10046628-Urine discoloration
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10062225-Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10006298-Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 67 at risk

Adverse event: 10022992-Irregular menstruation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10036601-Premature menopause
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10046901-Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10046904-Vaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10046912-Vaginal hemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10001723-Allergic rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 67 at risk

Adverse event: 10011224-Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 67 at risk

Adverse event: 10013963-Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 67 at risk

Adverse event: 10015090-Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: 10028735-Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10036402-Postnasal drip
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10036790-Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 67 at risk

Adverse event: 10041232-Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10041367-Sore throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10047924-Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10001760-Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 67 at risk

Adverse event: 10013786-Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10020642-Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10028691-Nail discoloration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 67 at risk

Adverse event: 10037087-Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10037847-Rash acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 67 at risk

Adverse event: 10037868-Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10040785-Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 67 at risk

Adverse event: 10040865-Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 67 at risk

Adverse event: 10062283-Nail ridging
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10027308-Menopause
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 67 at risk

Adverse event: 10041244-Social circumstances - Other, specify
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 67 at risk

Adverse event: 10016825-Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 67 at risk

Adverse event: 10019428-Hematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 67 at risk

Adverse event: 10020407-Hot flashes
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 67 at risk

Adverse event: 10020772-Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 52 affected / 67 at risk

Adverse event: 10021097-Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 67 at risk

Adverse event: 10047065-Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 67 at risk