estinal perforation
Ileus
Gastrointestinal ulcer
Hepatobiliary disorders
Venoocclusive liver disease
Hepatomegaly
Jaundice
Skin and subcutaneous tissue disorders
Rash
Pruritus
Alopecia
Erythema
Pigmentation disorder
Erythrodermic psoriasis
Severe toxic skin reactions including cases of Stevens-Johnson syndrome and toxic epidermal necrolysis
Musculoskeletal and connective tissue disorders
Back pain
Myalgia
Arthralgia
Renal and urinary disorders
Cystitis haemorrhagic
Dysuria
Oliguria
Renal failure
Cystitis
Haematuria
Reproductive system and breast disorders
Azoospermia
Amenorrhoea
Vaginal haemorrhage
Menopausal symptoms
Infertility female
Infertility male
General disorders and administration site conditions
Pyrexia
Asthenia
Chills
Generalised oedema
Injection site inflammation
Injection site pain
Mucosal inflammation
Multi-organ failure
Pain
Investigation
Weight increased
Blood bilirubin increased
Transaminases increased
Blood amylase increased
Blood creatinine increased
Blood urea increased
Gamma-glutamyltransferase increased
Blood alkaline phosphatase increased
Aspartate aminotransferase increased
Paediatric population
The adverse reactions considered at least possibly related to conditioning treatment including thiotepa, reported in paediatric 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
Not known
Infections and infestations
Infection susceptibility increased
Sepsis
Thrombocytopenic purpura
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related second malignancy
Blood and lymphatic system disorders
Thrombocytopenia
Febrile neutropenia
Anaemia
Pancytopenia
Granulocytopenia
Immune system disorders
Acute graft versus host disease
Chronic graft versus host disease
Endocrine disorders
Hypopituitarism
Hypogonadism
Hypothyroidism
Metabolism and nutrition disorders
Anorexia
Hyperglycaemia
Psychiatric disorders
Mental status changes
Mental disorder due to a general medical condition
Nervous system disorders
Headache
Encphalopathy
Convulsion
Cerebral haemorrhage
Memory impairment Paresis
Ataxia
Leukoencephalopathy
Ear and labyrinth disorders
Hearing impaired
Cardiac disorders
Cardiac arrest
Cardiovascular insufficiency
Cardiac failure
Vascular disorders
Haemorrhage
Hypertension
Respiratory, thoracic and mediastinal disorders
Pneumonitis
Idiopathic pneumonia syndrome
Pulmunary haemorrage
Pulmonary oedema
Epistaxis
Hypoxia
Respiratory arrest
Pulmonary arterial hypertension
Gastrointestin |
