Study: NCT01827930

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Notes: CARDIAC GENERAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Infection - Other (Specify, __)
Serious: yes
Organ System: Infections and infestations
Notes: INFECTION (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Notes: Immune system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 2 affected / 24 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 3 affected / 24 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 4 affected / 24 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: CARDIAC GENERAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 9 affected / 24 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN (SOC from CTCAE v3.0)
Frequency: 3 affected / 24 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN (SOC from CTCAE v3.0)
Frequency: 2 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 6 affected / 24 at risk

Adverse event: Gastrointestinal - Other (Specify, __)
Serious: no
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 2 affected / 24 at risk

Adverse event: Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: HEMORRHAGE/BLEEDING (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Infection - Other (Specify, __)
Serious: no
Organ System: Infections and infestations
Notes: INFECTION (SOC from CTCAE v3.0)
Frequency: 6 affected / 24 at risk

Adverse event: Edema:head and neck
Serious: no
Organ System: General disorders
Notes: LYMPHATICS (SOC from CTCAE v3.0)
Frequency: 3 affected / 24 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE v3.0)
Frequency: 2 affected / 24 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (Specify, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0)
Frequency: 9 affected / 24 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: NEUROLOGY (SOC from CTCAE v3.0)
Frequency: 2 affected / 24 at risk

Adverse event: Ocular/Visual - Other (Specify, __)
Serious: no
Organ System: Eye disorders
Notes: OCULAR/VISUAL (SOC from CTCAE v3.0)
Frequency: 2 affected / 24 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Notes: PAIN (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: PAIN (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Stomach
Serious: no
Organ System: Gastrointestinal disorders
Notes: PAIN (SOC from CTCAE v3.0)
Frequency: 2 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PULMONARY/UPPER RESPIRATORY (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PULMONARY/UPPER RESPIRATORY (SOC from CTCAE v3.0)
Frequency: 1 affected / 24 at risk

Adverse event: Cardiac General - Other (Specify, __)
Serious: yes
Organ System: Cardiac disorders
Notes: CARDIAC GENERAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Gastrointestinal - Other (Specify, __)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (Specify, __)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, __)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: PULMONARY/UPPER RESPIRATORY (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Renal/Genitourinary - Other (Specify, __)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: RENAL/GENITOURINARY (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Cardiac General - Other (Specify, __)
Serious: no
Organ System: Cardiac disorders
Notes: CARDIAC GENERAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: CARDIAC GENERAL (SOC from CTCAE v3.0)
Frequency: 2 affected / 25 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 3 affected / 25 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Gastrointestinal - Other (Specify, __)
Serious: no
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Infection - Other (Specify, __)
Serious: no
Organ System: Infections and infestations
Notes: INFECTION (SOC from CTCAE v3.0)
Frequency: 2 affected / 25 at risk

Adverse event: Edema:limb
Serious: no
Organ System: General disorders
Notes: LYMPHATICS (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (Specify, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0)
Frequency: 3 affected / 25 at risk

Adverse event: Ocular/Visual - Other (Specify, __)
Serious: no
Organ System: Eye disorders
Notes: OCULAR/VISUAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Notes: PAIN (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Renal/Genitourinary - Other (Specify, __)
Serious: no
Organ System: Renal and urinary disorders
Notes: RENAL/GENITOURINARY (SOC from CTCAE v3.0)
Frequency: 1 affected / 25 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Notes: Immune system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Immune system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 2 affected / 19 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Notes: Blood and lymphatic system disorders (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Cardiac General - Other (Specify, __)
Serious: no
Organ System: Cardiac disorders
Notes: CARDIAC GENERAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: CARDIAC GENERAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 2 affected / 19 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Induration/fibrosis (skin and subcutaneous tissue)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 4 affected / 19 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal - Other (Specify, __)
Serious: no
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: HEMORRHAGE/BLEEDING (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Infection - Other (Specify, __)
Serious: no
Organ System: Infections and infestations
Notes: INFECTION (SOC from CTCAE v3.0)
Frequency: 4 affected / 19 at risk

Adverse event: Edema:head and neck
Serious: no
Organ System: General disorders
Notes: LYMPHATICS (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Edema:limb
Serious: no
Organ System: General disorders
Notes: LYMPHATICS (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Lymphatics - Other (Specify, __)
Serious: no
Organ System: General disorders
Notes: LYMPHATICS (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (Specify, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0)
Frequency: 2 affected / 19 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: NEUROLOGY (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: OCULAR/VISUAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Ocular/Visual - Other (Specify, __)
Serious: no
Organ System: Eye disorders
Notes: OCULAR/VISUAL (SOC from CTCAE v3.0)
Frequency: 2 affected / 19 at risk

Adverse event: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Notes: OCULAR/VISUAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Notes: PAIN (SOC from CTCAE v3.0)
Frequency: 2 affected / 19 at risk

Adverse event: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: PAIN (SOC from CTCAE v3.0)
Frequency: 2 affected / 19 at risk

Adverse event: Stomach
Serious: no
Organ System: Gastrointestinal disorders
Notes: PAIN (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PULMONARY/UPPER RESPIRATORY (SOC from CTCAE v3.0)
Frequency: 2 affected / 19 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PULMONARY/UPPER RESPIRATORY (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: RENAL/GENITOURINARY (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Renal/Genitourinary - Other (Specify, __)
Serious: no
Organ System: Renal and urinary disorders
Notes: RENAL/GENITOURINARY (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk

Adverse event: Carotid
Serious: no
Organ System: Vascular disorders
Notes: VASCULAR (SOC from CTCAE v3.0)
Frequency: 1 affected / 19 at risk