|
Index of reports
> Cases with Multi-Organ Failure (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Mylotarg (Gemtuzumab Ozogamicin) where reactions include multi-organ failure. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Mylotarg side effects in 66 year old male
Reported by a physician from United Kingdom on 2012-08-17
Patient: 66 year old male, weighing 60.0 kg (132.0 pounds)
Reactions: Multi-Organ Failure, Neutropenic Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cytarabine
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Daunorubicin HCL
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Mylotarg
Dosage: 5.3 mg (total dose)
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Possible Mylotarg side effects in 66 year old male
Reported by a physician from United Kingdom on 2012-06-29
Patient: 66 year old male, weighing 60.0 kg (132.0 pounds)
Reactions: Multi-Organ Failure, Neutropenic Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cytarabine
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Mylotarg
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Daunorubicin HCL
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Possible Mylotarg side effects in 66 year old male
Reported by a physician from United Kingdom on 2012-06-18
Patient: 66 year old male
Reactions: Multi-Organ Failure, Neutropenic Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Cytarabine
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Daunorubicin HCL
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Possible Mylotarg side effects in 66 year old male
Reported by a physician from United Kingdom on 2012-06-01
Patient: 66 year old male
Reactions: Multi-Organ Failure, Neutropenic Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cytarabine
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Mylotarg
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Daunorubicin HCL
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Possible Mylotarg side effects in 66 year old male
Reported by a physician from United Kingdom on 2012-05-29
Patient: 66 year old male
Reactions: Multi-Organ Failure, Neutropenic Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Cytarabine
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Daunorubicin HCL
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2007-09-20
End date: 2007-09-22
Possible Mylotarg side effects in 74 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-07
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Multi-Organ Failure, Sepsis, Febrile Neutropenia, Atrial Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-11-22
End date: 2011-11-22
Azacitidine
Dosage: 160 milligram
Start date: 2011-11-15
End date: 2011-11-21
Possible Mylotarg side effects in 74 year old male
Reported by a physician from United States on 2012-02-10
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Multi-Organ Failure, Sepsis, Febrile Neutropenia, Atrial Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 mg/m2 over 2 hours on day 8
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-22
End date: 2011-11-22
Azacitidine
Dosage: 75 mg/m2 on days 1-7, 160 mg per day
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-15
End date: 2011-11-21
Possible Mylotarg side effects in 74 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-13
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Multi-Organ Failure, Sepsis, Febrile Neutropenia, Atrial Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Azacitidine
Dosage: 75 milligram/sq. meter
Start date: 2011-11-15
End date: 2011-11-21
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-11-22
End date: 2011-11-22
Possible Mylotarg side effects in 74 year old male
Reported by a physician from United States on 2011-12-28
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Multi-Organ Failure, Sepsis, Atrial Fibrillation, Febrile Neutropenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 mg/m2 over 2 hours on day 8, total dose administered this course 6.45mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-22
End date: 2011-11-22
Azacitidine
Dosage: 75mg/m2 on days 1-7, 160mg per day, total dose administered this course 1121mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-15
End date: 2011-11-21
Possible Mylotarg side effects in 74 year old male
Reported by a physician from United States on 2011-12-27
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Vomiting, Dyspnoea, Nausea, Tachycardia, Febrile Neutropenia, Atrial Fibrillation, Multi-Organ Failure, Sepsis, Tachypnoea
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Azacitidine
Dosage: 75mg/m2 on days 1-7, 160mg per day, total dose administered this course 1121mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-15
End date: 2011-11-21
Mylotarg
Dosage: 3 mg/m2 over 2 hours on day 8, total dose administered this course 6.45mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-22
End date: 2011-11-22
Possible Mylotarg side effects in 51 year old male
Reported by a physician from United Kingdom on 2011-12-15
Patient: 51 year old male
Reactions: Urine Output Decreased, General Physical Health Deterioration, Purpura, Ascites, Multi-Organ Failure, Weight Increased, Venoocclusive Disease, Dialysis, Sepsis, Aspartate Aminotransferase Increased, Pleural Effusion, Blood Creatinine Increased
Adverse event resulted in: death
Drug(s) suspected as cause:
Daunorubicin Citrate Liposome
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-23
End date: 2011-10-03
Daunorubicin Citrate Liposome
Indication: Myelodysplastic Syndrome
Mylotarg
Cytarabine
Other drugs received by patient: Piperacillin and Tazobactam; Vancomycin; Linezolid; Gentamycin Sulfate; Meropenem; Caspofungin Acetate
Possible Mylotarg side effects in female
Reported by a physician from Japan on 2011-11-03
Patient: female
Reactions: Multi-Organ Failure, Sepsis, Venoocclusive Liver Disease, General Physical Health Deterioration
Drug(s) suspected as cause:
Mylotarg
|
