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Thiotepa (Thiotepa Intracavitary) - Deafness - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Deafness (8)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Thiotepa (Thiotepa Intracavitary) where reactions include deafness. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Thiotepa side effects in 19 month old female

Reported by a individual with unspecified qualification from Canada on 2011-11-25

Patient: 19 month old female

Reactions: Neurological Decompensation, Deafness, Strabismus, Papilloedema, Sepsis, Eyelid Ptosis, Leukoencephalopathy, Central Nervous System Necrosis, Immunosuppression

Drug(s) suspected as cause:
Etoposide
    Dosage: 2.5 mg/kg, 1 in 1 d
    Indication: Brain Neoplasm Malignant

Cisplatin
    Dosage: 3.5 mg/kg
    Indication: Brain Neoplasm Malignant

Thiotepa
    Dosage: 10 mg/kg, 1 in 1 d
    Indication: Brain Neoplasm Malignant

Carboplatin
    Dosage: 17 mg/kg, 1 in 1 d
    Indication: Brain Neoplasm Malignant

Vincristine
    Dosage: 0.05 mg/kg, 1 in 1 d
    Indication: Brain Neoplasm Malignant

Cyclophosphamide
    Dosage: 60 mg/kg, 1 in 1 d
    Indication: Brain Neoplasm Malignant

Methotrexate
    Dosage: 8000 mg/m2
    Indication: Brain Neoplasm Malignant



Possible Thiotepa side effects in 19 month old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-24

Patient: 19 month old female

Reactions: Sepsis, Deafness, Leukoencephalopathy, Immunosuppression

Drug(s) suspected as cause:
Cyclophosphamide

Methotrexate
    Dosage: 1df= 8 g/m2

Cisplatin

Vincristine
    Dosage: two doses

Etoposide

Carboplatin

Thiotepa
    Dosage: 2 doses



Possible Thiotepa side effects in 19 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-16

Patient: 19 year old male

Reactions: Central Nervous System Lesion, Aphasia, Deafness, Cerebral Ventricle Dilatation, Strabismus, Papilloedema, Speech Disorder, Sepsis, Hypotonia, Eyelid Ptosis, Coordination Abnormal, Leukoencephalopathy, Hemiplegia, Blindness, Immunosuppression

Drug(s) suspected as cause:
Carboplatin
    Dosage: 17 mg/kg/day
    Indication: Chemotherapy

Cyclophosphamide
    Dosage: 0.05 mg/kg/day
    Indication: Chemotherapy

Etoposide
    Dosage: 2.5 mg/kg/day
    Indication: Chemotherapy

Radiotherapy
    Dosage: 45 gy in 25 daily fractions

Vincristine
    Dosage: 0.065 mg/kg, unk
    Indication: Chemotherapy

Cisplatin
    Dosage: 3.5 mg/kg, unk

Methotrexate
    Dosage: 8 mg/m2, unk
    Indication: Chemotherapy

Thiotepa
    Dosage: 10 mg/kg/day
    Indication: Chemotherapy



Possible Thiotepa side effects in 19 month old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-14

Patient: 19 month old female

Reactions: Sepsis, Deafness, Leukoencephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 60 mg/kg/day, 2 days
    Indication: Brain Neoplasm Malignant

Cisplatin
    Dosage: 3.5 mg/kg, 1 dose
    Indication: Brain Neoplasm Malignant

Vincristine
    Dosage: 0.05 mg/kg/day, 2 doses
    Indication: Brain Neoplasm Malignant

Carboplatin
    Dosage: high-dose: 17 mg/kg/day, 2 days
    Indication: Brain Neoplasm Malignant

Thiotepa
    Dosage: 10 mg/kg/day, 2 doses
    Indication: Brain Neoplasm Malignant

Etoposide
    Dosage: 2.5 mg/kg/day, 3 days
    Indication: Brain Neoplasm Malignant

Methotrexate
    Dosage: high dose: 8g/m2, 2 cycles
    Indication: Brain Neoplasm Malignant



Possible Thiotepa side effects in 19 month old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-14

Patient: 19 month old female

Reactions: Sepsis, Deafness, Leukoencephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Etoposide
    Dosage: 2.5 mg/kg/day, 3 days
    Indication: Brain Neoplasm Malignant

Methotrexate
    Dosage: high dose: 8g/m2, 2 cycles
    Indication: Brain Neoplasm Malignant

Cyclophosphamide
    Dosage: 60 mg/kg/day, 2 days
    Indication: Brain Neoplasm Malignant

Carboplatin
    Dosage: high-dose: 17 mg/kg/day, 2 days
    Indication: Brain Neoplasm Malignant

Cisplatin
    Dosage: 3.5 mg/kg, 1 dose
    Indication: Brain Neoplasm Malignant

Vincristine
    Dosage: 0.05 mg/kg/day, 2 doses
    Indication: Brain Neoplasm Malignant

Thiotepa
    Dosage: 10 mg/kg/day, 2 doses
    Indication: Brain Neoplasm Malignant



Possible Thiotepa side effects in 19 month old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-14

Patient: 19 month old female

Reactions: Sepsis, Deafness, Leukoencephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: 3.5 mg/kg, 1 dose
    Indication: Brain Neoplasm Malignant

Methotrexate
    Dosage: high dose: 8g/m2, 2 cycles
    Indication: Brain Neoplasm Malignant

Cyclophosphamide
    Dosage: 60 mg/kg/day, 2 days
    Indication: Brain Neoplasm Malignant

Vincristine
    Dosage: 0.05 mg/kg/day, 2 doses
    Indication: Brain Neoplasm Malignant

Etoposide
    Dosage: 2.5 mg/kg/day, 3 days
    Indication: Brain Neoplasm Malignant

Carboplatin
    Dosage: high-dose: 17 mg/kg/day, 2 days
    Indication: Brain Neoplasm Malignant

Thiotepa
    Dosage: 10 mg/kg/day, 2 doses
    Indication: Brain Neoplasm Malignant



Possible Thiotepa side effects in 19 month old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-14

Patient: 19 month old female

Reactions: Sepsis, Deafness, Leukoencephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vincristine
    Dosage: 0.05 mg/kg/day, 2 doses
    Indication: Brain Neoplasm Malignant

Etoposide
    Dosage: 2.5 mg/kg/day, 3 days
    Indication: Brain Neoplasm Malignant

Cyclophosphamide
    Dosage: 60 mg/kg/day, 2 days
    Indication: Brain Neoplasm Malignant

Methotrexate
    Dosage: high dose: 8g/m2, 2 cycles
    Indication: Brain Neoplasm Malignant

Cisplatin
    Dosage: 3.5 mg/kg, 1 dose
    Indication: Brain Neoplasm Malignant

Carboplatin
    Dosage: high-dose: 17 mg/kg/day, 2 days
    Indication: Brain Neoplasm Malignant

Thiotepa
    Dosage: 10 mg/kg/day, 2 doses
    Indication: Brain Neoplasm Malignant



Possible Thiotepa side effects in 19 month old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-07

Patient: 19 month old female

Reactions: Deafness, Stem Cell Transplant, Speech Disorder, Hypotonia, Sepsis, Coordination Abnormal, Leukoencephalopathy, Blindness, Immunosuppression, Inflammation

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Thiotepa
    Dosage: 10 mg/kg/day
    Indication: Brain Neoplasm Malignant

(Therapeutic Radiopharmaceuticals)
    Dosage: 10.8 gy in 6 fractions, 45 gy in 25 daily fractions
    Indication: Brain Neoplasm Malignant

Cyclophosphamide
    Dosage: 60 mg/kg/day
    Indication: Brain Neoplasm Malignant

Carboplatin
    Dosage: 17 mg/kg/day
    Indication: Brain Neoplasm Malignant

Methotrexate
    Dosage: 8 gm/m^2
    Indication: Brain Neoplasm Malignant

Vincristine Sulfate
    Dosage: 0.05 mg/kg/day
    Indication: Brain Neoplasm Malignant

Cisplatin
    Dosage: 3.5 mg/kg
    Indication: Brain Neoplasm Malignant

Etoposide
    Dosage: 2.5 mg/kg/day
    Indication: Brain Neoplasm Malignant

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