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Thiotepa (Thiotepa Intracavitary) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Thiotepa (Thiotepa Intracavitary) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (59)
Death (29)
Life Threatening Events (4)
Disability (4)

Reports by Reaction Type

Leukoencephalopathy (15)Sepsis (12)Respiratory Failure (9)Deafness (8)Acute Respiratory Distress Syndrome (7)Pneumomediastinum (5)Pneumothorax (5)Death (4)Aspiration (4)Immunosuppression (4)Mucosal Inflammation (4)Hypotonia (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Thiotepa (Thiotepa Intracavitary). For a complete list or a specific selection of reports, please use the links above.

Possible Thiotepa side effects in 9 year old female

Reported by a physician from Israel on 2012-07-27

Patient: 9 year old female

Reactions: Transplant Failure, Post Transplant Lymphoproliferative Disorder, Guillain-Barre Syndrome, Pericarditis, Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Busulfex
    Dosage: 3.2 mg/kg, daily dose, days 9 to 6, intravenous
    Indication: Bone Marrow Conditioning Regimen

Anti-Thymocyte Globulin Rabbit NOS
    Dosage: 2.5 mg/kg/d on days -4 to (10mg/kg); 2.5 mg/kg/d on days - 4 to -2
    Indication: Bone Marrow Conditioning Regimen

Fludarabine Phosphate
    Dosage: 30 mg/m2/d on days 0 to -5 (180mg/m^2); 40 mg/d/d on days -5 to -3
    Indication: Bone Marrow Conditioning Regimen

Thiotepa
    Dosage: 5mg/kg/d on days; 8 mg/kg/d on day - 7
    Indication: Bone Marrow Conditioning Regimen

Other drugs received by patient: Azathioprine (Azathioprine0; Treosulfan (Treosulfan); Acyclovir; Hydroxyurea; Cyclosporine



Possible Thiotepa side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-28

Patient: female, weighing 13.2 kg (29.0 pounds)

Reactions: Vomiting, Malaise, Diarrhoea, Febrile Neutropenia, Somnolence, Eating Disorder, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 476 mg
    End date: 2012-06-12

Thiotepa
    Dosage: 280 mg
    End date: 2012-06-12



Possible Thiotepa side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-27

Patient: female, weighing 13.2 kg (29.0 pounds)

Reactions: Vomiting, Parainfluenzae Virus Infection, Diarrhoea, Hypophagia, Decreased Activity, Fluid Intake Reduced, Febrile Neutropenia, Hypersomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thiotepa
    Dosage: 280 mg
    End date: 2012-06-12

Carboplatin
    Dosage: 476 mg
    End date: 2012-06-12



Possible Thiotepa side effects in 4 year old male

Reported by a physician from Israel on 2012-06-14

Patient: 4 year old male

Reactions: Generalised Oedema, Polyserositis, Pericardial Effusion, Ascites, Periorbital Oedema, Weight Increased, Oedema Peripheral, Pleural Effusion

Drug(s) suspected as cause:
Fludarabine Phosphate
    Indication: Prophylaxis Against Transplant Rejection

Atgam
    Indication: Prophylaxis Against Transplant Rejection

Busulfan
    Indication: Prophylaxis Against Transplant Rejection

Cyclophosphamide
    Indication: Prophylaxis Against Transplant Rejection

Thiotepa
    Indication: Prophylaxis Against Transplant Rejection



Possible Thiotepa side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-17

Patient:

Reactions: Pancreatitis Acute

Drug(s) suspected as cause:
Levofloxacin
    Indication: Antibiotic Prophylaxis

Thiotepa
    Dosage: 10 mg/kg/
    Indication: Haematological Malignancy

Fludarabine Phosphate
    Dosage: 160 mg/m2/
    Indication: Haematological Malignancy

Valaciclovir
    Indication: Antiviral Prophylaxis

Melphalan Hydrochloride
    Dosage: 140 mg/m2/
    Indication: Haematological Malignancy

Rabbit Antithymocyte Immu (Formulation Unknown) (Rabbit Antithymocyte
    Indication: Haematological Malignancy



Possible Thiotepa side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: male

Reactions: Dialysis, Nephropathy Toxic, Renal Failure Acute

Drug(s) suspected as cause:
Rabbit Antithymocyte Immu (Formulation Unknown) (Rabbit Antithymocyte
    Indication: Haematological Malignancy

Valaciclovir
    Indication: Antiviral Prophylaxis

Fludarabine Phosphate
    Dosage: 160 mg/mg
    Indication: Haematological Malignancy

Levofloxacin
    Indication: Antibiotic Prophylaxis

Melphalan Hydrochloride
    Dosage: 140 mg/m2
    Indication: Haematological Malignancy

Thiotepa
    Dosage: 10 mg/kg
    Indication: Haematological Malignancy



Possible Thiotepa side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-17

Patient:

Reactions: Nephropathy Toxic, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Valaciclovir
    Indication: Antiviral Prophylaxis

Rabbit Antithymocyte Immu (Formulation Unknown) (Rabbit Antithymocyte
    Indication: Haematological Malignancy

Melphalan Hydrochloride
    Dosage: 140 mg/m2/
    Indication: Haematological Malignancy

Fludarabine Phosphate
    Dosage: 160 mg/m2/
    Indication: Haematological Malignancy

Levofloxacin
    Indication: Antibiotic Prophylaxis

Thiotepa
    Dosage: 10 mg/kg/
    Indication: Haematological Malignancy



Possible Thiotepa side effects in male

Reported by a physician from United States on 2012-04-24

Patient: male, weighing 12.1 kg (26.6 pounds)

Reactions: Neutropenic Colitis, Acidosis, Caecitis, Barotrauma, Ascites, Mucosal Inflammation, Acute Lung Injury, Acute Respiratory Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Thiotepa
    Dosage: 510 mg

Cyclophosphamide
    Dosage: 3360 mg



Possible Thiotepa side effects in male

Reported by a physician from Germany on 2012-04-23

Patient: male, weighing 14.8 kg (32.6 pounds)

Reactions: Peritonitis Bacterial, Sepsis, Neutropenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Fludara
    Indication: Stem Cell Transplant

Treosulfan
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-09-06
    End date: 2011-09-12

Treosulfan
    Indication: Stem Cell Transplant

Thiotepa
    Indication: Stem Cell Transplant

Anti-Thymocyte Globulin Equine NOS
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-09-06
    End date: 2011-09-12

Clofarabine
    Dosage: 44 mg/m2, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-08-10
    End date: 2011-08-14

Fludara
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-09-06
    End date: 2011-09-12

Etopophos Preservative Free
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-08-10
    End date: 2011-08-14

Cyclophosphamide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-08-10
    End date: 2011-08-14

Thiotepa
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-09-06
    End date: 2011-09-12

Anti-Thymocyte Globulin Equine NOS
    Indication: Stem Cell Transplant

Other drugs received by patient: Acyclovir; Amikacin; Zyvox; Granocyte; Cyclosporine; Amikacin; Acyclovir; Tigecycline; Zyvox; Prednisolone; Granocyte; Tigecycline



Possible Thiotepa side effects in 3 year old

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-17

Patient: 3 year old

Reactions: Respiratory Failure, Pneumomediastinum, Acute Respiratory Distress Syndrome, Pneumothorax

Adverse event resulted in: death

Drug(s) suspected as cause:
Carboplatin
    Dosage: unk
    Indication: Medulloblastoma

Cyclophosphamide
    Dosage: unk
    Indication: Medulloblastoma

Etoposide
    Dosage: unk
    Indication: Medulloblastoma

Thiotepa
    Dosage: unk
    Indication: Medulloblastoma



Possible Thiotepa side effects in 65 year old male

Reported by a physician from United States on 2012-04-17

Patient: 65 year old male

Reactions: Encephalitis Cytomegalovirus, Graft Versus Host Disease, Central Nervous System Lesion, Panencephalitis, CNS Ventriculitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Thiotepa
    Indication: Diffuse Large B-Cell Lymphoma

Thiotepa
    Indication: Myeloid Leukaemia

Thiotepa
    Indication: Myelodysplastic Syndrome

Rituximab
    Indication: Diffuse Large B-Cell Lymphoma

Rituximab
    Indication: Myeloid Leukaemia

Rituximab
    Indication: Myelodysplastic Syndrome

Idarubicin HCL
    Indication: Diffuse Large B-Cell Lymphoma

Idarubicin HCL
    Indication: Myelodysplastic Syndrome

Idarubicin HCL
    Indication: Myeloid Leukaemia

Fludarabine Phosphate
    Indication: Diffuse Large B-Cell Lymphoma

Fludarabine Phosphate
    Indication: Myelodysplastic Syndrome

Fludarabine Phosphate
    Indication: Myeloid Leukaemia

Etoposide
    Indication: Diffuse Large B-Cell Lymphoma

Etoposide
    Indication: Myelodysplastic Syndrome

Etoposide
    Indication: Myeloid Leukaemia

Valaciclovir
    Indication: Myeloid Leukaemia

Valaciclovir
    Indication: Cytomegalovirus Infection

Valaciclovir
    Indication: Myelodysplastic Syndrome

Depocyt
    Indication: Diffuse Large B-Cell Lymphoma

Depocyt
    Indication: Myelodysplastic Syndrome

Depocyt
    Indication: Myeloid Leukaemia

Mitoxantrone
    Indication: Myelodysplastic Syndrome

Mitoxantrone
    Indication: Myeloid Leukaemia

Mitoxantrone
    Indication: Diffuse Large B-Cell Lymphoma

Anti-Thymocyte Globulin Equine NOS
    Indication: Diffuse Large B-Cell Lymphoma

Anti-Thymocyte Globulin Equine NOS
    Indication: Myelodysplastic Syndrome

Anti-Thymocyte Globulin Equine NOS
    Indication: Myeloid Leukaemia

Foscarnet
    Indication: Myelodysplastic Syndrome

Foscarnet
    Indication: Cytomegalovirus Infection

Foscarnet
    Indication: Myeloid Leukaemia

Acyclovir
    Indication: Myeloid Leukaemia

Acyclovir
    Indication: Cytomegalovirus Infection

Acyclovir
    Indication: Myelodysplastic Syndrome



Possible Thiotepa side effects in 3 year old

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-12

Patient: 3 year old

Reactions: Respiratory Failure, Pneumomediastinum, Hypercapnia, Pneumothorax, Acute Respiratory Distress Syndrome, Platelet Count Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Medulloblastoma

Etoposide
    Indication: Medulloblastoma

Carboplatin
    Indication: Medulloblastoma

Thiotepa
    Indication: Medulloblastoma



Possible Thiotepa side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-11

Patient:

Reactions: Stem Cell Transplant, Pulmonary Alveolar Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Melphalan Hydrochloride
    Dosage: 140 mg/m2
    Indication: Neuroblastoma

Busulfan
    Dosage: 600 mg/m2
    Indication: Neuroblastoma

Thiotepa
    Dosage: 300 mg/m2 / per day
    Indication: Neuroblastoma



Possible Thiotepa side effects in 3 year old

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-10

Patient: 3 year old

Reactions: Respiratory Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Thiotepa
    Indication: Medulloblastoma

Cyclophosphamide
    Indication: Medulloblastoma

Etoposide
    Indication: Medulloblastoma

Carboplatin
    Indication: Medulloblastoma



Possible Thiotepa side effects in 3 year old

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-06

Patient: 3 year old

Reactions: Respiratory Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Etoposide
    Indication: Medulloblastoma

Carboplatin
    Indication: Medulloblastoma

Thiotepa
    Indication: Medulloblastoma

Cyclophosphamide
    Indication: Medulloblastoma



Possible Thiotepa side effects in 6 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-02

Patient: 6 year old female

Reactions: Pneumonia, Abscess Fungal, Mental Status Changes, Renal Abscess, Pyrexia, Convulsion, Stem Cell Transplant, Encephalitis Cytomegalovirus, Graft Versus Host Disease in Skin, Sepsis, Hydrocephalus, CNS Ventriculitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Methylprednisolone
    Dosage: not reported, unknown, unknown
    Indication: Graft Versus Host Disease

Anti-Thymocyte Globulin Equine NOS
    Dosage: not reported, unknown, unknown
    Indication: Acute Lymphocytic Leukaemia Recurrent

Cytarabine
    Dosage: not reported, unknown, unknown
    Indication: Acute Lymphocytic Leukaemia Recurrent

Therapeutic Radiopharmaceuticals
    Dosage: not reported, unknown, other
    Indication: Acute Lymphocytic Leukaemia Recurrent

Thiotepa
    Dosage: not reported, unknown, unknown
    Indication: Acute Lymphocytic Leukaemia Recurrent

Immune Globulin NOS
    Dosage: not reported, unknown, unknown
    Indication: Acute Lymphocytic Leukaemia Recurrent

Ganciclovir
    Dosage: 12 mg/kg, unknown, unknown
    Indication: Cytomegalovirus Viraemia

Corticosteroids
    Dosage: not reported, unknown, unknown
    Indication: Acute Lymphocytic Leukaemia Recurrent

Cidofovir
    Dosage: two doses, unknown, unknown
    Indication: Cytomegalovirus Viraemia

Foscarnet Sodium
    Dosage: 90 mg/kg, unknown, unknown
    Indication: Cytomegalovirus Viraemia

Monoclonal Antibodies
    Dosage: not reported, unknown, unknown
    Indication: Graft Versus Host Disease



Possible Thiotepa side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-30

Patient: 65 year old male

Reactions: Encephalitis Cytomegalovirus, CNS Ventriculitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: not reported, unknown, unknown
    Indication: Myelodysplastic Syndrome

Cytarabine
    Dosage: not reported, unknown, unknown
    Indication: Diffuse Large B-Cell Lymphoma

Cytarabine
    Dosage: not reported, unknown, unknown
    Indication: Acute Myeloid Leukaemia

Idarubicin HCL
    Dosage: not reported, unknown, unknown
    Indication: Myelodysplastic Syndrome

Idarubicin HCL
    Dosage: not reported, unknown, unknown
    Indication: Diffuse Large B-Cell Lymphoma

Valaciclovir
    Dosage: not reported, unknown, unknown
    Indication: Cytomegalovirus Viraemia

Etoposide
    Dosage: not reported, unknown, unknown
    Indication: Myelodysplastic Syndrome

Etoposide
    Dosage: not reported, unknown, unknown
    Indication: Diffuse Large B-Cell Lymphoma

Acyclovir
    Dosage: not reported, unknown, unknown
    Indication: Cytomegalovirus Viraemia

Rituximab
    Dosage: not reported, unknown, unknown
    Indication: Myelodysplastic Syndrome

Rituximab
    Dosage: not reported, unknown, unknown
    Indication: Diffuse Large B-Cell Lymphoma

Foscarnet Sodium
    Dosage: not reported, unknown, unknown
    Indication: Cytomegalovirus Viraemia

Mitoxantrone Hydrochloride
    Dosage: not reported, unknown, unknown
    Indication: Diffuse Large B-Cell Lymphoma

Mitoxantrone Hydrochloride
    Dosage: not reported, unknown, unknown
    Indication: Myelodysplastic Syndrome

Anti-Thymocyte Globulin Equine NOS
    Dosage: not reported, unknown, unknown
    Indication: Myelodysplastic Syndrome

Anti-Thymocyte Globulin Equine NOS
    Dosage: not reported, unknown, unknown
    Indication: Acute Myeloid Leukaemia

Anti-Thymocyte Globulin Equine NOS
    Dosage: not reported, unknown, unknown
    Indication: Diffuse Large B-Cell Lymphoma

Fludarabine Phosphate
    Dosage: not reported, unknown, unknown
    Indication: Diffuse Large B-Cell Lymphoma

Fludarabine Phosphate
    Dosage: not reported, unknown, unknown
    Indication: Myelodysplastic Syndrome

Fludarabine Phosphate
    Dosage: not reported, unknown, unknown
    Indication: Acute Myeloid Leukaemia

Therapeutic Radiopharmaceuticals
    Dosage: not reported, unknown, other
    Indication: Diffuse Large B-Cell Lymphoma

Therapeutic Radiopharmaceuticals
    Dosage: not reported, unknown, other
    Indication: Myelodysplastic Syndrome

Thiotepa
    Dosage: not reported, unknown, unknown
    Indication: Myelodysplastic Syndrome

Thiotepa
    Dosage: not reported, unknown, unknown
    Indication: Acute Myeloid Leukaemia

Thiotepa
    Dosage: not reported, unknown, unknown
    Indication: Diffuse Large B-Cell Lymphoma



Possible Thiotepa side effects in 3 year old

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-29

Patient: 3 year old

Reactions: Respiratory Failure, Pneumomediastinum, Acute Respiratory Distress Syndrome, Pneumothorax

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Etoposide
    Dosage: hit 2000 met-bis4 protocol
    Indication: Medulloblastoma

Thiotepa
    Dosage: hit 2000 met-bis4 protocol
    Indication: Medulloblastoma

Cyclophosphamide
    Dosage: hit 2000 met-bis4 protocol
    Indication: Medulloblastoma

Carboplatin
    Dosage: hit 2000 met-bis4 protocol
    Indication: Medulloblastoma



Possible Thiotepa side effects in 3 year old

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-29

Patient: 3 year old

Reactions: Respiratory Failure, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: hit 2000 met-bis4 protocol
    Indication: Medulloblastoma

Carboplatin
    Dosage: hit 2000 met-bis4 protocol
    Indication: Medulloblastoma

Etoposide
    Dosage: hit 2000 met-bis4 protocol
    Indication: Medulloblastoma

Thiotepa
    Dosage: hit 2000 met-bis4 protocol
    Indication: Medulloblastoma



Possible Thiotepa side effects in 3 year old

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-27

Patient: 3 year old

Reactions: Death, Respiratory Failure, Hypercapnia, Pneumomediastinum, Acute Respiratory Distress Syndrome, Pneumothorax

Adverse event resulted in: death

Drug(s) suspected as cause:
Carboplatin
    Indication: Medulloblastoma

Thiotepa
    Indication: Medulloblastoma

Cyclophosphamide
    Indication: Medulloblastoma

Etoposide
    Indication: Medulloblastoma



Possible Thiotepa side effects in 3 year old

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-22

Patient: 3 year old

Reactions: Death, Respiratory Failure, Hypercapnia, Pneumomediastinum, Acute Respiratory Distress Syndrome, Pneumothorax

Adverse event resulted in: death

Drug(s) suspected as cause:
Thiotepa
    Indication: Medulloblastoma

Cyclophosphamide
    Indication: Medulloblastoma

Etoposide
    Indication: Medulloblastoma

Carboplatin
    Indication: Medulloblastoma



Possible Thiotepa side effects in male

Reported by a individual with unspecified qualification from France on 2012-03-15

Patient: male, weighing 13.1 kg (28.7 pounds)

Reactions: Mucosal Inflammation, Vomiting, Diarrhoea, Hypotonia, Quadriparesis, Decreased Appetite, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ondansetron HCL
    Indication: Vomiting
    Start date: 2011-11-02

Thiotepa
    Dosage: cyclic / intravenous
    Indication: Brain Neoplasm Malignant
    Start date: 2011-10-30
    End date: 2011-11-01

Carboplatin
    Dosage: cyclic / intravenous
    Indication: Brain Neoplasm Malignant
    Start date: 2011-10-27
    End date: 2011-10-29

Alizapride Hydrochloride (Formulation Unknown) (Alizapride Hydrochlori
    Indication: Vomiting
    Start date: 2011-11-02

Ceftazidime Sodium
    Dosage: 430 mg / three times per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-02

Kabiven
    Indication: Enteral Nutrition
    Start date: 2011-11-02

Vancomycin HCL
    Dosage: 135 mg / four times per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-02



Possible Thiotepa side effects in male

Reported by a physician from France on 2012-03-08

Patient: male, weighing 13.1 kg (28.8 pounds)

Reactions: Hypotonia, Quadriparesis, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kabiven
    Indication: Enteral Nutrition
    Start date: 2011-11-02

Carboplatin
    Dosage: 289mg per day
    Indication: Brain Neoplasm Malignant
    Start date: 2011-10-27
    End date: 2011-10-29

Plitican
    Indication: Vomiting
    Start date: 2011-11-02

Zofran
    Indication: Vomiting
    Start date: 2011-11-02

Ceftazidime
    Dosage: 430mg three times per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-02

Vancomycin
    Dosage: 135mg four times per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-02

Thiotepa
    Dosage: 170mg per day
    Indication: Brain Neoplasm Malignant
    Start date: 2011-10-30
    End date: 2011-11-01

Other drugs received by patient: Stem Cell Transplant



Possible Thiotepa side effects in 4 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-23

Patient: 4 year old male

Reactions: Fluid Overload, Jaundice, Pulmonary Veno-Occlusive Disease, Refractoriness To Platelet Transfusion, Neutropenic Sepsis, Pyrexia, Ascites, Haematemesis, Weight Increased, Mucosal Inflammation, Hepatomegaly, Malaise, Tachypnoea, Hypoxia, Pleural Effusion

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Bone Marrow Conditioning Regimen

(Alemtuzumab)

Busulfan
    Dosage: tablet 14 mg/kg

Methotrexate

Thiotepa
    Indication: Bone Marrow Conditioning Regimen

Cyclosporine
    Indication: Prophylaxis Against Graft Versus Host Disease



Possible Thiotepa side effects in female

Reported by a physician from United States on 2012-02-17

Patient: female, weighing 10.4 kg (22.9 pounds)

Reactions: Neutropenic Colitis, Respiratory Failure, Post Procedural Complication, Pulmonary Oedema, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
G-CSF (Filgrastim, Amgen)
    Dosage: 357mcg

Thiotepa
    Dosage: 210 mg

Carboplatin
    Dosage: 356 mg



Possible Thiotepa side effects in 56 year old male

Reported by a physician from Norway on 2012-02-06

Patient: 56 year old male

Reactions: Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Carboplatin
    Dosage: 7x(gfr+25) mg daily, cyclic (day1-4)
    Indication: Testis Cancer

Cyclophosphamide
    Dosage: 1500 mg/m2 daily, cyclic (day 1-4)
    Indication: Testis Cancer

Thiotepa
    Dosage: 120 mg/m2 daily, cyclic (day 1-4)
    Indication: Testis Cancer



Possible Thiotepa side effects in male

Reported by a physician from United Kingdom on 2012-02-02

Patient: male

Reactions: Venoocclusive Disease, Cytomegalovirus Infection, Acidosis, Pneumonia Cytomegaloviral

Adverse event resulted in: death

Drug(s) suspected as cause:
Thiotepa
    Indication: Bone Marrow Conditioning Regimen

Cyclosporine
    Indication: Prophylaxis Against Graft Versus Host Disease

Busulfan
    Dosage: 14mgk unknown
    Indication: Bone Marrow Conditioning Regimen

Methotrexate
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclophosphamide
    Dosage: 200mgk unknown
    Indication: Bone Marrow Conditioning Regimen

Alemtuzumab
    Indication: Bone Marrow Conditioning Regimen



Possible Thiotepa side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-23

Patient: 65 year old male

Reactions: Multi-Organ Failure, Lung Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Busulfan
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-12-02
    End date: 2011-12-04

Cyclophosphamide
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-12-05
    End date: 2011-12-06

Thiotepa
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2011-11-29
    End date: 2011-12-01

Mesna
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-05
    End date: 2011-12-06

Other drugs received by patient: Clonazepam



Possible Thiotepa side effects in 48 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-01-19

Patient: 48 year old male

Reactions: Dermatitis, Metaplasia, Oedema, Erythema

Drug(s) suspected as cause:
Carboplatin
    Indication: Bone Marrow Transplant

Cyclophosphamide
    Indication: Bone Marrow Transplant

Thiotepa
    Indication: Bone Marrow Transplant



Possible Thiotepa side effects in female

Reported by a physician from Japan on 2012-01-12

Patient: female, weighing 20.0 kg (44.0 pounds)

Reactions: Stomatitis, Alanine Aminotransferase Increased, Sepsis, Bone Marrow Failure, Bacterial Infection, Pyrexia, Decreased Appetite, Infection

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Alkeran
    Dosage: 50mgm2 per day
    Start date: 2008-09-17
    End date: 2008-09-18

Thiotepa
    Dosage: 150mgm2 per day
    Start date: 2008-09-17
    End date: 2008-09-18

Thiotepa
    Dosage: 150mgm2 per day
    Indication: Stem Cell Transplant
    Start date: 2008-09-10
    End date: 2008-09-11

Alkeran
    Dosage: 50mgm2 per day
    Indication: Stem Cell Transplant
    Start date: 2008-09-10
    End date: 2008-09-11

Other drugs received by patient: Immune Globulin Intravenous (Human); Meropenem; High-Calorie Transfusion Fluid; Immune Globulin (Human); Neupogen; Neutrogin; Cefpirome; Tobramycin; Prodif

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