Study: NCT01157091

Adverse event: 10000081-Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10028813-Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10016256-Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10062501-Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10023424-Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: 10040872-Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: 10046571-Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: 10001675-Alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: 10011368-Creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: 10025256-Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: 10029366-Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: 10035528-Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: 10020949-Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10069339-Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10020772-Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10002272-Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 28 at risk

Adverse event: 10033557-Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10034474-Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10040741-Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 28 at risk

Adverse event: 10040752-Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 28 at risk

Adverse event: aortic sclerosis w/o significant stenosis, mitral annular calcification
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10005886-Blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10000081-Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 28 at risk

Adverse event: 10002167-Anal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10005265-Bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10009887-Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10010774-Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 28 at risk

Adverse event: 10012727-Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 28 at risk

Adverse event: 10013781-Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10016766-Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: 10017853-Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10019611-Hemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10028130-Mucositis oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10028813-Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 28 at risk

Adverse event: 10031009-Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10038062-Rectal fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10038064-Rectal hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10038072-Rectal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10042112-Stomach pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10047700-Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 28 at risk

Adverse event: 10054520-Oral dysesthesia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10066874-Gastroesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10008531-Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10016256-Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 28 at risk

Adverse event: 10016558-Fever
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10016791-Flu like symptoms
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10017577-Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10033371-Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 28 at risk

Adverse event: 10050068-Edema limbs
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10062466-Localized edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10062501-Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10040753-Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: 10040872-Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: 10046300-Upper respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 28 at risk

Adverse event: 10046571-Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: 10061229-Lung infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: 10016173-Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: 10001551-Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 28 at risk

Adverse event: 10001675-Alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 28 at risk

Adverse event: 10003481-Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 28 at risk

Adverse event: 10005364-Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 28 at risk

Adverse event: 10008661-Cholesterol high
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: 10011368-Creatinine increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 28 at risk

Adverse event: 10025256-Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 28 at risk

Adverse event: 10029366-Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 28 at risk

Adverse event: 10035528-Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 28 at risk

Adverse event: 10047896-Weight gain
Serious: no
Organ System: Investigations
Frequency: 5 affected / 28 at risk

Adverse event: 10047900-Weight loss
Serious: no
Organ System: Investigations
Frequency: 16 affected / 28 at risk

Adverse event: 10049182-White blood cell decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 28 at risk

Adverse event: 10055599-Hemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: 10056910-GGT increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 28 at risk

Adverse event: 10002646-Anorexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 28 at risk

Adverse event: 10012174-Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10020587-Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10020639-Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 28 at risk

Adverse event: 10020647-Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 28 at risk

Adverse event: 10020670-Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10020680-Hypernatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 28 at risk

Adverse event: 10020870-Hypertriglyceridemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 28 at risk

Adverse event: 10020943-Hypoalbuminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 28 at risk

Adverse event: 10020949-Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 28 at risk

Adverse event: 10021005-Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 28 at risk

Adverse event: 10021018-Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10021028-Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10021038-Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 28 at risk

Adverse event: 10021059-Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 28 at risk

Adverse event: 10029883-Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10003239-Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 28 at risk

Adverse event: 10003246-Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10003988-Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 28 at risk

Adverse event: 10006002-Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10016750-Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10028411-Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 28 at risk

Adverse event: 10028836-Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10031282-Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10033425-Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 28 at risk

Adverse event: 10048677-Buttock pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10048706-Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10062572-Generalized muscle weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10065895-Muscle weakness upper limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Joint effusion with extensive nodular synovial proliferation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Transitional cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 28 at risk

Adverse event: 10013573-Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 28 at risk

Adverse event: 10013911-Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10019211-Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 28 at risk

Adverse event: 10024264-Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10033987-Paresthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10034620-Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10041349-Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10051272-Facial muscle weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Piriformis syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10002855-Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 28 at risk

Adverse event: 10022437-Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10019450-Hematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10037032-Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 28 at risk

Adverse event: 10046539-Urinary frequency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10046555-Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10046628-Urine discoloration
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10061574-Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10062225-Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10034263-Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10046904-Vaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10046916-Vaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10011224-Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10013963-Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: 10028735-Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10036790-Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10041367-Sore throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10047681-Voice alteration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10001760-Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10013786-Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10015218-Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10037087-Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10037868-Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10040868-Skin hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10040947-Skin ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: hand-foot syndrome symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10016825-Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: 10020407-Hot flashes
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 28 at risk

Adverse event: 10020772-Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 28 at risk

Adverse event: 10021097-Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 28 at risk