Study: NCT00566995

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 37 at risk

Adverse event: Constitutional Symptoms - Other (Specify, generalized weakness)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, jaw pain and L shoulder pain)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain::Chest wall
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary/Upper Respiratory - Other, bronchitis; viral pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 37 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 37 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 37 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 37 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 37 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 37 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 37 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 37 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 37 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 37 at risk

Adverse event: Cardiac Arrhythmia - Other (Specify, __)
Serious: no
Organ System: Cardiac disorders
Notes: nonspecific T-wave abnormality
Frequency: 1 affected / 37 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Constitutional Symptoms - Other (Specify, extreme hunger and jitterness)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 37 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 37 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 37 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: cold sore on lip-herpes simplex
Frequency: 1 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 37 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 37 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 37 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 37 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 37 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 37 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 37 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 37 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 37 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 37 at risk

Adverse event: Hemorrhage, GU::Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 37 at risk

Adverse event: Hemorrhage, GU::Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 37 at risk

Adverse event: Hemorrhage, GU::Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hemorrhage/Bleeding - Other (Specify, hematuria)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 37 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Infection - Other (Specify, bladder infection)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Dental-tooth
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 37 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 37 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 37 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 37 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 37 at risk

Adverse event: Malabsorption
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Mood alteration::Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Mood alteration::Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 37 at risk

Adverse event: Mood alteration::Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 37 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (Specify, crushed thumb)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 37 at risk

Adverse event: Neurology - Other (Specify, R lower extremity foot weakness)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Ocular/Visual - Other (Specify, corneal epithelial defect)
Serious: no
Organ System: Eye disorders
Notes: corneal epithelial defect
Frequency: 1 affected / 37 at risk

Adverse event: Otitis, external ear (non-infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, bilateral ankle pain)
Serious: no
Organ System: General disorders
Notes: bilateral ankle pain
Frequency: 1 affected / 37 at risk

Adverse event: Pain::Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Pain::Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 37 at risk

Adverse event: Pain::Dental/teeth/peridontal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain::Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 37 at risk

Adverse event: Pain::Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain::Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain::Oral-gums
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain::Pelvis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 37 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 37 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 37 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 37 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 37 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 37 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 37 at risk

Adverse event: Prolonged QTc interval
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 37 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 37 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, asthma)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 37 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 37 at risk

Adverse event: Renal/Genitourinary - Other (Specify, hematuria)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Seroma
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 37 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 37 at risk

Adverse event: Supraventricular and nodal arrhythmia::Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 37 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 37 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 37 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 37 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 37 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 37 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 37 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 37 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 9 affected / 37 at risk

Adverse event: Cardiac arrhythmia-Other, Specify (tachycardia)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dermatology/Skin - Other (Specify, dry scalp)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dermatology/Skin - Other (Specify,dry, chapped lips)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dermatology/Skin - Other (Specify,eczematous dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dermatology/Skin - Other (Specify, erythema L leg)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dermatology/Skin - Other (Specify, erythema on face)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dermatology/Skin - Other (Specify, paronychia of L great toe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Infection - Other (Specify, bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Infection - Other (Specify, sinusitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Infection - Other (Specify, tooth abscess)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Infection - Other (Specify, sinus infection)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Ocular/Visual - Other (Specify, corneal verticillata)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Ocular/Visual - Other (Specify, halos at night)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Ocular/Visual - Other (Specify, ocular/visual other-vortex keratopathy)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, cramp in extremities)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, dysuria)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, intermittent chest/thorax)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, left elbow)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, myalgia)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, pain bilateral feet)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, pain under R ribcage)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, pain-L elbow pain)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, pain-R ankle pain)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, R shoulder)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, suprapubic)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain - Other (Specify, tooth sensitivity)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, bronchitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, cold)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, cold symptoms)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, congestion)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, upper respiratory infection)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Renal/Genitourinary - Other (Specify, LUTS Syndrome - decreased urinary flow)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Renal/Genitourinary - Other (Specify, microscopic hematuria)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk