Study: NCT00392821

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blood albumin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Bilirubin - abnormal
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bronchiospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Constitutional symptoms, Other (Temperature intolerance)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Edema: NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Elevated BUN
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3 at risk

Adverse event: Hand-Foot Syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3 at risk

Adverse event: Hematologic: ANC
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hematologic: Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Hematologic: Platelets
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hematologic: WBC
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Haematuria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperchloridemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypochloridemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Increased Alanine transaminase, ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Infection (Eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Infection (joint)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: International normalized ratio - abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Metabolic/Lab, Other (abnormal CO2 )
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Metabolic/Lab, Other (abnormal HCT)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Metabolic/Lab, Other (abnormal Ketones)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Metabolic/Lab, Other (abnormal LDH)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Mood Alteration (Depression)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3 at risk

Adverse event: Neuropathy (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Neuropathy (NOS)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: neuropathy (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Ocular, Other (difficulty, L eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain (abdomen)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain (chest)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain (flank)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain (joint)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Pain (muscle)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain (neck)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain (skin)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Partial Thromboplastin Time (PTT)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Phosphorous
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Voice changes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: weekness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Bronchiospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Elevated BUN
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hand-Foot Syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hematologic: Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 5 affected / 6 at risk

Adverse event: Hematologic: Platelets
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Infection(Sinus)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Infection(Urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Metabolic/Lab, Other(LDH)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Pain (joint)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 3 affected / 6 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 6 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: CNS Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 69 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 69 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Hemorrhage, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 69 at risk

Adverse event: Infection - lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 69 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: Pain - back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: Pain - chest
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 69 at risk

Adverse event: Pain - stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 69 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 69 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Stabilization of thoracic spine
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: Vascular - atherosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 69 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: Blood albumin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 69 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 8 affected / 69 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 69 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 69 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 69 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 5 affected / 69 at risk

Adverse event: Bilirubin - abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 69 at risk

Adverse event: CNS ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 69 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 69 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 15 affected / 69 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 69 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 69 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 69 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 69 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 69 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 69 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 10 affected / 69 at risk

Adverse event: Edema: NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 69 at risk

Adverse event: Edema:headandneck
Serious: no
Organ System: General disorders
Frequency: 5 affected / 69 at risk

Adverse event: Elevated BUN
Serious: no
Organ System: Investigations
Frequency: 4 affected / 69 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 47 affected / 69 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 69 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 69 at risk

Adverse event: Hand-Foot Syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 15 affected / 69 at risk

Adverse event: Hematologic: ANC
Serious: no
Organ System: Investigations
Frequency: 7 affected / 69 at risk

Adverse event: Hematologic: Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 19 affected / 69 at risk

Adverse event: Hematologic: Platelets
Serious: no
Organ System: Investigations
Frequency: 23 affected / 69 at risk

Adverse event: Hematologic: WBC
Serious: no
Organ System: Investigations
Frequency: 14 affected / 69 at risk

Adverse event: Haematuria
Serious: no
Organ System: Investigations
Frequency: 4 affected / 69 at risk

Adverse event: Hemorrhage(nose)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 69 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 69 at risk

Adverse event: Hyperchloridemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 69 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 69 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 69 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 69 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 69 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 69 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 69 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 69 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 69 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 69 at risk

Adverse event: Increased Alanine transaminase, ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 3 affected / 69 at risk

Adverse event: Infection(Sinus)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 69 at risk

Adverse event: Infection(Urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 69 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 69 at risk

Adverse event: International normalized ratio - abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: Metabolic/Lab, Other (abnormal HCT)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: Metabolic/Lab, Other(LDH)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 69 at risk

Adverse event: Mood Alteration (Anxiety)
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 69 at risk

Adverse event: Mood Alteration (Depression)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 69 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 69 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 36 affected / 69 at risk

Adverse event: Neuropathy (motor)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 69 at risk

Adverse event: neuropathy (sensory)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 69 at risk

Adverse event: Pain (abdomen)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 69 at risk

Adverse event: Pain (back)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 69 at risk

Adverse event: Pain (chest)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 69 at risk

Adverse event: Pain (flank)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Pain (joint)
Serious: no
Organ System: General disorders
Frequency: 19 affected / 69 at risk

Adverse event: Pain (muscle)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 69 at risk

Adverse event: Pain (neck)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Pain (skin)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Phosphorous
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 20 affected / 69 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 69 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 69 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 69 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: General disorders
Frequency: 4 affected / 69 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 69 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 11 affected / 69 at risk

Adverse event: Voice changes
Serious: no
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 14 affected / 69 at risk

Adverse event: weekness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 69 at risk