Study: NCT00397982

Adverse event: Leukoencephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: grade 2 leukoencephalopathy, reversible.
Frequency: 1 affected / 17 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: grade 4 lymphopenia, both were evident pre-treatment at grade 1 and grade 3 for the two patients, respectively.
Frequency: 2 affected / 17 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: grade 3 lymphopenia
Frequency: 1 affected / 17 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: grade 3
Frequency: 2 affected / 17 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: grade 3 anemia (hemoglobin)
Frequency: 1 affected / 17 at risk

Adverse event: Opportunistic infection
Serious: yes
Organ System: Infections and infestations
Notes: grade 3
Frequency: 1 affected / 17 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: grade 3 hypertension
Frequency: 1 affected / 17 at risk

Adverse event: Mucositis (funct/sympt) - Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Notes: grade 3 mucositis
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: grade 3 nausea
Frequency: 1 affected / 17 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: General disorders
Notes: grade 3 pain
Frequency: 1 affected / 17 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: General disorders
Notes: grade 3 headache
Frequency: 1 affected / 17 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Notes: grade 3 weight loss
Frequency: 2 affected / 17 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Notes: grade 3 anorexia
Frequency: 1 affected / 17 at risk

Adverse event: low CD4 count
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: grade 3 decrease in CD4 counts
Frequency: 1 affected / 17 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Immune system disorders
Notes: grade 1 rhinitis: 1 patient
Frequency: 1 affected / 17 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lymphopenia in 5 patients (1 grade 1, 3 grade 2, 1 grade 3), not including the 2 patients with lymphopenia SAEs.
Frequency: 5 affected / 17 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension, 1 grade 2. This is in addition to the 1 grade 3 SAE.
Frequency: 1 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 6 grade 1, 5 grade 2.
Frequency: 11 affected / 17 at risk

Adverse event: Pruritis/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 6 grade 1 , 2 grade 2
Frequency: 8 affected / 17 at risk

Adverse event: Mucositis - funct/sympt oral
Serious: no
Organ System: Gastrointestinal disorders
Notes: 4 grade 1, 3 grade 2, in addition to 1 grade 3 SAE
Frequency: 7 affected / 17 at risk

Adverse event: Hemorrhage / Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 7 grade 1, 1 grade 2.
Frequency: 8 affected / 17 at risk

Adverse event: Infection, normal ANC, abdomen
Serious: no
Organ System: Infections and infestations
Notes: 1 grade 2.
Frequency: 1 affected / 17 at risk

Adverse event: Edema - limb
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Edema: 1 grade 1, 2 grade 2
Frequency: 4 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 7 grade 1, 2 grade 2, in addition to the one grade 3 SAE.
Frequency: 9 affected / 17 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: one grade 1 urinary frequency
Frequency: 1 affected / 17 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: hypotension: 3 grade 1, 1 grade 2
Frequency: 4 affected / 17 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever: 3 grade 1, 3 grade 2
Frequency: 6 affected / 17 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Notes: 8 grade 1, 1 grade 2
Frequency: 9 affected / 17 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: 1 grade 1.
Frequency: 1 affected / 17 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: rash: 12 grade 1, 1 grade 2.
Frequency: 13 affected / 17 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 grade 1, 1 grade 2
Frequency: 2 affected / 17 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 12 grade 1 only.
Frequency: 12 affected / 17 at risk

Adverse event: Rash - acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 6 grade 1 only.
Frequency: 6 affected / 17 at risk

Adverse event: Wound complications, non-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 4 grade 1.
Frequency: 4 affected / 17 at risk

Adverse event: Hair loss / alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 3 grade 1.
Frequency: 3 affected / 17 at risk

Adverse event: Dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 grade 1.
Frequency: 1 affected / 17 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: 4 grade 1, 5 grade 2, plus 2 wt loss SAEs.
Frequency: 9 affected / 17 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: 10 grade 1, 2 grade 2, in addition to 1 grade 3 SAE.
Frequency: 12 affected / 17 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 4 grade 1, 1 grade 1
Frequency: 5 affected / 17 at risk

Adverse event: mucositis - larynx
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 grade 1
Frequency: 3 affected / 17 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 grade 1
Frequency: 2 affected / 17 at risk

Adverse event: mucositis - esophagus
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 grade 1.
Frequency: 1 affected / 17 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: GI - other
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Hemorrhage - lung
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Hemorrhage - rectal
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Infection, normal ANC, oral cavity
Serious: no
Organ System: Infections and infestations
Notes: 1 grade 2
Frequency: 1 affected / 17 at risk

Adverse event: Infection (other)
Serious: no
Organ System: Infections and infestations
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Edema - head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Notes: 3 grade 2, in addition to 2 grade 3 (SAE)
Frequency: 3 affected / 17 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Notes: 3 grade 1, in addition to 2 grade 3 SAEs
Frequency: 3 affected / 17 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Notes: 4 grade 1, 3 grade 2.
Frequency: 7 affected / 17 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Notes: 8 grade 1, 1 grade 2
Frequency: 9 affected / 17 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Notes: Elevated AST: 7 grade 1, 1 grade 2.
Frequency: 8 affected / 17 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Notes: Elevated alkaline phosphatase: 4 grade 1, 1 grade 2.
Frequency: 5 affected / 17 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Notes: 3 grade 1, 1 grade 2
Frequency: 4 affected / 17 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Notes: Elevated creatinine: 2 grade 1, 1 grade 2
Frequency: 3 affected / 17 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Notes: 1 grade 1, 1 grade 2
Frequency: 2 affected / 17 at risk

Adverse event: Blood cholesterol
Serious: no
Organ System: Investigations
Notes: Increased cholesterol: 10 grade 1
Frequency: 10 affected / 17 at risk

Adverse event: low serum bicarbonate
Serious: no
Organ System: Investigations
Notes: grade 1: 7
Frequency: 7 affected / 17 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Notes: Elevated ALT: 4 grade 1
Frequency: 4 affected / 17 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Notes: 2 grade 1.
Frequency: 2 affected / 17 at risk

Adverse event: Acidosis
Serious: no
Organ System: Investigations
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Investigations
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Investigations
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 3 grade 1, 1 grade 2
Frequency: 4 affected / 17 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 grade 2
Frequency: 1 affected / 17 at risk

Adverse event: Pulmonary - other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Pain - extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 2 grade 1
Frequency: 2 affected / 17 at risk

Adverse event: Pain - joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 2 grade 1
Frequency: 2 affected / 17 at risk

Adverse event: Pain - muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 2 grade 1
Frequency: 2 affected / 17 at risk

Adverse event: Pain - oral cavity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2 grade 1
Frequency: 2 affected / 17 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2 grade 1
Frequency: 2 affected / 17 at risk

Adverse event: Pain - chest wall
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Pain - oral - gums
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Pain - other
Serious: no
Organ System: General disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Pain - scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Pain - skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: pain - throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: flu-like syndrome
Serious: no
Organ System: General disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Pain - anus
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 grade 2
Frequency: 1 affected / 17 at risk

Adverse event: Pain - stomach
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 grade 2
Frequency: 1 affected / 17 at risk

Adverse event: Pain - tumor
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: 1 grade 2
Frequency: 1 affected / 17 at risk

Adverse event: Pain - abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 grade 1, 1 grade 2, in addition to the one grade 3 SAE
Frequency: 3 affected / 17 at risk

Adverse event: Pain - headache
Serious: no
Organ System: Nervous system disorders
Notes: seven grade 1, in addition to the one grade 3 SAE.
Frequency: 7 affected / 17 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: low hemoglobin: 8 grade 1, 5 grade 2, in addition to the one grade 3 SAE
Frequency: 13 affected / 17 at risk

Adverse event: Platelets (thrombocytopenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 11 grade 1, 3 grade 2
Frequency: 14 affected / 17 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: 3 grade 1, 5 grade 2
Frequency: 8 affected / 17 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 grade 1, muscle weakness, lower extremity
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 6 grade 1, 4 grade 2
Frequency: 10 affected / 17 at risk

Adverse event: mucositis - clinical exam - oral
Serious: no
Organ System: Gastrointestinal disorders
Notes: 7 grade 1, 3 grade 2
Frequency: 10 affected / 17 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 4 grade 1, 2 grade 2
Frequency: 6 affected / 17 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 5 grade 1, 1 grade 2
Frequency: 6 affected / 17 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 3 grade 1, 1 grade 2
Frequency: 4 affected / 17 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Notes: 2 grade 1, 1 grade 2
Frequency: 3 affected / 17 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 grade 2
Frequency: 1 affected / 17 at risk

Adverse event: mucositis - vaginal
Serious: no
Organ System: Reproductive system and breast disorders
Notes: 1 grade 2
Frequency: 1 affected / 17 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: 10 grade 1
Frequency: 10 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: 6 grade 1
Frequency: 6 affected / 17 at risk

Adverse event: voice changes
Serious: no
Organ System: General disorders
Notes: 6 grade 1
Frequency: 6 affected / 17 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Notes: 4 grade 1
Frequency: 4 affected / 17 at risk

Adverse event: nasal/paranasal reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 3 grade 1
Frequency: 3 affected / 17 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Notes: 2 grade 1
Frequency: 2 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 2 grade 1
Frequency: 2 affected / 17 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 grade 1
Frequency: 2 affected / 17 at risk

Adverse event: hypopigmentation - skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Nervous system disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: 1 grade 1
Frequency: 1 affected / 17 at risk