Study: NCT00706992

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 8 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: OCULAR/VISUAL:: Ocular/Visual-Other, left conjunctivitis (inflammation)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain - Other, body aches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 8 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 9 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 9 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 9 at risk

Adverse event: OCULAR/VISUAL:: Ocular/Visual-Other (Specify)
Serious: no
Organ System: Eye disorders
Notes: Decreased vision; Blurry vision due to retinal edema
Frequency: 2 affected / 9 at risk

Adverse event: Pain - Other, body pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 8 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 8 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 8 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 8 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Gastrointestinal - Other, sigmoid diverticulosis (incidental finding on CT scan)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: OCULAR/VISUAL:: Ocular/Visual-Other, vision changes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 6 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 5 at risk

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

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 5 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 5 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 5 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk