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Clolar (Clofarabine) - Febrile Neutropenia - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Febrile Neutropenia (14)

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

Possible Clolar side effects in female

Reported by a physician from Australia on 2012-07-19

Patient: female

Reactions: Atrial Fibrillation, Febrile Neutropenia, Constipation, Delusion, Haemoglobin Decreased, Fatigue, Myocardial Infarction, Hallucination, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2010-10-25
    End date: 2010-10-29

Clolar
    Dosage: unk
    Start date: 2010-11-29
    End date: 2010-12-03

Other drugs received by patient: Metformin Hydrochloride



Possible Clolar side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Enterovesical Fistula, Oedema Peripheral, Febrile Neutropenia, Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 3820 mg, qd for induction treatment, for 5 days
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-03-16
    End date: 2012-03-20

Cytarabine
    Dosage: 3600 mg, qd, for 4 days
    Start date: 2012-04-28
    End date: 2012-05-01

Neupogen
    Dosage: 300 mcg, qd
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-03-15
    End date: 2012-04-04

Clolar
    Dosage: 57.3 mg, qd, for 5 days
    Start date: 2012-03-16
    End date: 2012-03-20

Neupogen
    Dosage: 300 mcg, qd
    Start date: 2012-04-28
    End date: 2012-05-01

Clolar
    Dosage: 46 mg, qd for consolidation treatment
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-28

Other drugs received by patient: Nicotine; Docusate; Lorazepam; Hydrocodone Bitartrate and Acetaminophen; Ondansetron (Zofran); Omeprazole; Lorazepam; Zolpidem; Acyclovir; Senna-Mint WAF; Oxycodone HCL; Levaquin; Voriconazole



Possible Clolar side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14

Patient: male

Reactions: Sepsis, Febrile Neutropenia, Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clolar



Possible Clolar side effects in 66 year old male

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

Patient: 66 year old male

Reactions: Febrile Neutropenia, Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clolar



Possible Clolar side effects in male

Reported by a physician from United States on 2012-06-05

Patient: male

Reactions: Enterovesical Fistula, Oedema Peripheral, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia

Clolar
    Dosage: 46 mg, qd for consolidation treatment
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-28

Clolar
    Dosage: for induction treatment
    Start date: 2012-03-16
    End date: 2012-03-20

Neupogen
    Dosage: unk
    Indication: Acute Myeloid Leukaemia

Other drugs received by patient: Oxycodone Hydrochloride; Docusate; Levaquin; Acyclovir; Hydrocodone Bitartrate and Acetaminophen; Lorazepam; Voriconazole; Nicotine; Omeprazole; Lorazepam; Zolpidem; Senna-Mint WAF; Ondansetron



Possible Clolar side effects in male

Reported by a physician from Argentina on 2012-05-23

Patient: male

Reactions: Acute Lymphocytic Leukaemia, Device Related Sepsis, Vomiting, Rash Erythematous, Febrile Neutropenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Etoposide
    Dosage: 150 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia

Cyclophosphamide
    Dosage: 440 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia

Clolar
    Dosage: 40 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia



Possible Clolar side effects in male

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

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Cardio-Respiratory Arrest, Mouth Haemorrhage, Unresponsive To Stimuli, Febrile Neutropenia, Pleural Effusion, Pancytopenia, Pneumonitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Clolar



Possible Clolar side effects in male

Reported by a consumer/non-health professional from Australia on 2011-12-19

Patient: male

Reactions: Pleural Effusion, Febrile Neutropenia, Urinary Retention, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: 20 mg/m2, qdx5 cycle 1
    Indication: Acute Leukaemia
    Start date: 2011-01-18
    End date: 2011-01-22

Clolar
    Dosage: 20 mg/m2, qdx5 cycle 3

Clolar
    Dosage: 20 mg/m2, qdx5 cycle 4
    End date: 2011-04-16

Ondansetron
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Clolar
    Dosage: 20 mg/m2, qdx5 cycle 2



Possible Clolar side effects in 11 year old male

Reported by a physician from Colombia on 2011-12-02

Patient: 11 year old male, weighing 41.0 kg (90.2 pounds)

Reactions: Capillary Leak Syndrome, Vomiting, Respiratory Failure, Chest Pain, Febrile Neutropenia, Fluid Retention

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 400/m2 x 5 days
    Indication: Acute Lymphocytic Leukaemia

Etoposide
    Dosage: 100/m2 x 5 days
    Indication: Acute Lymphocytic Leukaemia

Clolar
    Dosage: 40 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-05-05

Other drugs received by patient: Dexamethasone; Hydroxyzine



Possible Clolar side effects in 8 year old female

Reported by a physician from Colombia on 2011-12-02

Patient: 8 year old female, weighing 20.0 kg (44.0 pounds)

Reactions: Sepsis, Febrile Neutropenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Etoposide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Clolar
    Dosage: 40 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia

Cyclophosphamide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Other drugs received by patient: Fluconazole; Ciprofloxacin



Possible Clolar side effects in 11 year old female

Reported by a physician from Colombia on 2011-11-30

Patient: 11 year old female, weighing 35.0 kg (77.0 pounds)

Reactions: Large Intestine Perforation, Stomatitis, Neutropenic Colitis, Anaemia, Febrile Neutropenia, Pyrexia, Klebsiella Bacteraemia, Burkholderia Cepacia Complex Sepsis, Thrombocytopenia, Sinusitis, Leukopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: 60 mg (52 mg/m2), qdx5 (cycle 1)
    Indication: Acute Lymphocytic Leukaemia

Clolar
    Dosage: 60 mg (52 mg/m2), qdx5 (cycle 2)

Other drugs received by patient: Acetaminophen; Hydrocortisone; Hydroxyzine; Ranitidine; Ondansetron



Possible Clolar side effects in 11 year old female

Reported by a physician from Colombia on 2011-10-11

Patient: 11 year old female, weighing 35.0 kg (77.0 pounds)

Reactions: Large Intestine Perforation, Neutropenic Colitis, Stomatitis, Anaemia, Febrile Neutropenia, Pyrexia, Klebsiella Bacteraemia, Death, Thrombocytopenia, Sinusitis, Leukopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Clolar
    Dosage: 60 mg (52 mg/m2), qdx5 (cycle 1)
    Indication: Acute Lymphocytic Leukaemia

Clolar
    Dosage: 60 mg (52 mg/m2), qdx5 (cycle 2)

Other drugs received by patient: Hydrocortisone; Ondansetron; Acetaminophen; Hydroxyzine; Ranitidine



Possible Clolar side effects in 8 year old female

Reported by a physician from Colombia on 2011-10-11

Patient: 8 year old female, weighing 20.0 kg (44.0 pounds)

Reactions: Sepsis, Febrile Neutropenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Clolar
    Dosage: 40 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia

Cyclosporine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Etoposide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Other drugs received by patient: Ciprofloxacin; Fluconazole



Possible Clolar side effects in female

Reported by a physician from Venezuela on 2011-10-05

Patient: female, weighing 6.9 kg (15.2 pounds)

Reactions: Pulmonary Sepsis, Hepatotoxicity, Febrile Neutropenia, Acute Respiratory Failure, Lower Respiratory Tract Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Clolar
    Dosage: 52 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-08-09

Clolar
    Indication: Acute Leukaemia

Other drugs received by patient: Ciprofloxacin; Bactron; Fluconazole

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