ceived thiotepa for conditioning treatment prior to haematopoietic progenitor cell transplantation.
Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process. These include infection and Graft-versus host disease (GvHD) which, although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
The most frequently adverse reactions reported in the different conditioning treatments including thiotepa are: infections, cytopenia, acute GvHD and chronic GvHD, gastrointestinal disorders, haemorrhagic cystitis, mucosal inflammation.
Leukoencephalopathy
Cases of leukoencephalopathy have been observed following treatment with thiotepa in adult and paediatric patients with multiple previous chemotherapies, including methotrexate and radiotherapy. Some cases had a fatal outcome.
Tabulated list of adverse reactions
Adults
The adverse reactions considered at least possibly related to conditioning treatment including thiotepa, reported in adult patients as more than an isolated case, are listed below by system organ class and by frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
System organ class
Very common
Common
Uncommon
Not known
Infections and infestations
Infection susceptibility increased
Sepsis
Toxic shock syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related second malignancy
Blood and lymphatic system disorders
Leukopenia
Thrombocytopenia
Febrile neutropenia
Anaemia
Pancytopenia
Granulocytopeni
Immune system disorders
Acute graft versus host disease
Chronic graft versus host disease
Hypersensitivity
Endocrine disorders
Hypopituitarism
Metabolism and nutrition disorders
Anorexia
Decreased appetite
Hyperglycaemia
Psychiatric disorders
Confusional state
Mental status changes
Anxiety
Delirium
Nervousness
Hallucination
Agitation
Nervous system disorders
Dizziness
Headache
Vision blurred
Encephalopathy
Convulsion
Paraesthesia
Intracranial aneurysm
Extrapyramidal disorder
Cognitive disorder
Cerebral haemorrhage
Leukoencephalopathy
Eye disorders
Conjunctivitis
Cataract
Ear and labyrinth disorders
Hearing impaired
Ototoxicity
Tinnitus
Cardiac disorders
Arrhythmia
Tachycardia
Cardiac failure
Cardiomyopathy
Myocarditis
Vascular disorders
Lymphoedema
Hypertension
Haemorrhage
Embolism
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
Epistaxis
Pulmonary oedema
Cough
Pneumonitis
Hypoxia
Gastrointestinal disorders
Nausea
Stomatitis
Oesophagitis
Vomiting
Diarrhoea
Dyspepsia
Abdominal pain
Enteritis
Colitis
Constipation
Gastroint |
