Study: NCT00238433

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related to treatment regimen.
Frequency: 5 affected / 36 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Ileum obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related to treatment regimen.
Frequency: 20 affected / 36 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related to treatment regimen.
Frequency: 8 affected / 36 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related to treatment regimen.
Frequency: 2 affected / 36 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Related to treatment regimen.
Frequency: 33 affected / 36 at risk

Adverse event: Influenza A
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Related to treatment regimen.
Frequency: 2 affected / 36 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Opioid overdose
Serious: yes
Organ System: Psychiatric disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to treatment regimen.
Frequency: 2 affected / 36 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to treatment regimen.
Frequency: 5 affected / 36 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Unrelated to treatment regimen.
Frequency: 2 affected / 36 at risk

Adverse event: Auto GVHD
Serious: no
Organ System: Immune system disorders
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Clostridium difficile colitis (C. diff)
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Entercolitis
Serious: no
Organ System: Infections and infestations
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Colitis
Serious: no
Organ System: Infections and infestations
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Abnormal ALT (alanine aminotransferase ) lab result
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Abnormal amylase lab result
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Related to treatment regimen.
Frequency: 4 affected / 36 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 9 affected / 36 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 5 affected / 36 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to treatment regimen.
Frequency: 14 affected / 36 at risk

Adverse event: Muscle weakness (lower limb)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Bronchitis/early bronchopneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Related to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: General skin rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to treatment regimen.
Frequency: 1 affected / 36 at risk

Adverse event: Thiotepa-induced skin rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to treatment regimen.
Frequency: 3 affected / 36 at risk