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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