Study: NCT00048737

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: # of participants affected-1
Frequency: 1 affected / 70 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: C-Diff Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Viral Hepatitis B reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: secondary malignancy- Melanoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Prolonged Hospitalization, Generalized Weakness/Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Death due to G.I. GVHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Secondary Malignancy-Early Nodular Basal Cell Carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Death Due to Chronic Liver/G.I GVHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Neuoropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 70 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 70 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 70 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 70 at risk

Adverse event: Elevated Alkaline Phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 70 at risk

Adverse event: Increased Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 70 at risk

Adverse event: Increased LDH
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 70 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 70 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 70 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 70 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Low Ejection Fraction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 70 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 70 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 70 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Mood altered
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 70 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 70 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 70 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 70 at risk

Adverse event: Skin Dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 70 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Altered Mood-Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Fasciitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 70 at risk