Study: NCT00987480

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Blood/Bone Marrow, Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cardiopulmonary arrest, cause unknkown
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Gastrointestinal, other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage, Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage, Respiratory tract NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage, Stoma (GI)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 45 at risk

Adverse event: Ileus, GI (func obstruction of bowel)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Meningitis(meninges)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Myositis infection(muscle)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection w/ Gr 3/4 neut, Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Mucositis (Clin exam)- Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Neurology - Other (specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pneumonitis/pulm infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Pulm/upp respiratory - Other (spec)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Sodium, high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 45 at risk

Adverse event: Glucose, low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 45 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 45 at risk

Adverse event: Mucositis (Clin exam)- Pharynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Phosphate, low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 45 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 45 at risk

Adverse event: Infection, other
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 45 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 45 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 6 affected / 45 at risk

Adverse event: Magnesium, high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 45 at risk

Adverse event: Magnesium, low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 45 at risk

Adverse event: Trglycrde, high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 45 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 45 at risk

Adverse event: Potassium, high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 45 at risk

Adverse event: PTT
Serious: no
Organ System: Investigations
Frequency: 7 affected / 45 at risk

Adverse event: Albumin, low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 45 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 8 affected / 45 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 8 affected / 45 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 45 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 45 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 45 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 45 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 8 affected / 45 at risk

Adverse event: Sodium, low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 45 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 10 affected / 45 at risk

Adverse event: Potassium, low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 45 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 11 affected / 45 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 11 affected / 45 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 45 at risk

Adverse event: Mucositis (Clin exam)- Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 45 at risk