Study: NCT01594216

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: anemia (grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 15 at risk

Adverse event: neutropenia (grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: infection (grade 2)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: thrombocytopenia (grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 15 at risk

Adverse event: pain (grade 2)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 15 at risk

Adverse event: psychiatric (grade 2)
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 15 at risk

Adverse event: pulmonary (grade 2)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: other gastrointestinal (grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 15 at risk

Adverse event: elevated liver function test (grade 2)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: pain (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 15 at risk

Adverse event: constipation (grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: fatigue (grade 2)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 15 at risk

Adverse event: hypertension (grade 2)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 15 at risk

Adverse event: hypertension (grade 3)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: other gastrointestinal (grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: diarrhea (grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: headache (grade 1)
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 15 at risk

Adverse event: headache (grade 2)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: nausea/vomiting (grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: pain (grade 3)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: anemia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 15 at risk

Adverse event: anemia (grade 3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 15 at risk

Adverse event: pulmonary (grade 1)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: urinary (grade 1)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: pulmonary (grade 3)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: elevated hepatic function (grade 1)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 15 at risk

Adverse event: neutropenia (grade 1)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: flu-like symptoms (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 15 at risk

Adverse event: infection (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 15 at risk

Adverse event: psychiatric (grade 1)
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 15 at risk

Adverse event: neurological (grade 1)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 15 at risk

Adverse event: dizziness (grade 2)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: edema (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: edema (grade 2)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: hyponatremia (grade 3)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: psychiatric (grade 3)
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 15 at risk

Adverse event: psychiatric (grade 2)
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 15 at risk

Adverse event: palpitations (grade 1)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: pericarditis (grade 2)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: decreased white blood cells (grade 1)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 15 at risk

Adverse event: decreased white blood cells (grade 2)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: premature menopause (grade 3)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: hot flashes (grade 1)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 15 at risk

Adverse event: hot flashes (grade 2)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: elevated creatinine (grade 1)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 15 at risk

Adverse event: arthritis (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: dehydration (grade 1)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: pruritis (grade 1)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: blurred vision (grade 2)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: urinary incontinence (grade 3)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: urinary tract infection (grade 2)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: neutropenia (grade 3)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: decreased white blood cells (grade 3)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: type 2 diabetes (grade 2)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: presyncope (grade 2)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: osteoporosis (grade 2)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: osteoporosis (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: hypothyroidism (grade 2)
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 15 at risk

Adverse event: hypothyroidism (grade 1)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: fracture (grade 2)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: chest pressure (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: hypoalbuminemia (grade 2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: elevated BNP (grade 1)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: elevated creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 10 at risk

Adverse event: anemia (grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: neutropenia (grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: infection (grade 2)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: pain (grade 2)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 10 at risk

Adverse event: psychiatric (grade 2)
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 10 at risk

Adverse event: pulmonary (grade 2)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: nausea/vomiting (grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: other gastrointestinal (grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: elevated liver function test (grade 2)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: pain (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 10 at risk

Adverse event: constipation (grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: fatigue (grade 1)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: fatigue (grade 3)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: hypertension (grade 2)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: hypertension (grade 3)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 10 at risk

Adverse event: other gastrointestinal (grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: diarrhea (grade 3)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: headache (grade 1)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: nausea/vomiting (grade 3)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: pain (grade 3)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: anemia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 10 at risk

Adverse event: anemia (grade 3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: pulmonary (grade 1)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 10 at risk

Adverse event: pulmonary (grade 3)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: elevated hepatic function (grade 1)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 10 at risk

Adverse event: neutropenia (grade 1)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: flu-like symptoms (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: infection (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: psychiatric (grade 1)
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: neurological (grade 1)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: hyponatremia (grade 1)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: dizziness (grade 2)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: decreased white blood cells (grade 1)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: decreased white blood cells (grade 2)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: vaginal bleeding (grade 1)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: hot flashes (grade 1)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: elevated creatinine (grade 1)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: dehydration (grade 1)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: hypercalcemia (grade 2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: hypermagnesemia (grade 1)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: hypokalemia (grade 1)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: decreased chloride (grade 1)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: flu-like symptoms (grade 2)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: leg cramps (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: decreased AST (grade 2)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: fall (grade 2)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk