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Clolar (Clofarabine) - Pyrexia - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Pyrexia (16)

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

Possible Clolar side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: male, weighing 121.9 kg (268.2 pounds)

Reactions: Pruritus, Unresponsive To Stimuli, Device Related Infection, Pyrexia, Candidiasis, Abscess Limb, Ventricular Extrasystoles, Metabolic Acidosis, Dyspnoea, Hypotension, Pancytopenia, Tremor, Convulsion, Respiratory Failure, Fungal Infection, Ventricular Tachycardia, Sepsis, Respiratory Arrest, Pulse Absent, Sinus Tachycardia, Hypertension, Feeling Abnormal, Cardiac Arrest, Escherichia Infection, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epinephrine
    Dosage: 4 df, unk
    Indication: Cardiac Arrest
    Start date: 2012-07-14
    End date: 2012-07-14

Cyclophosphamide
    Dosage: daily for 5 days
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-19
    End date: 2012-06-23

Oncaspar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-02
    End date: 2012-07-02

Epinephrine
    Dosage: unk
    Start date: 2012-07-14
    End date: 2012-07-14

Clolar
    Dosage: 74.4 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-19
    End date: 2012-06-23

Etoposide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-19
    End date: 2012-06-23

Vincristine Sulfate
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-02
    End date: 2012-07-02

Other drugs received by patient: Colace; Bactrim; Stomatitis Mouthwash; Prilosec; Lortab; Cymbalta; Ondansetron; Ambien



Possible Clolar side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male, weighing 115.0 kg (253.0 pounds)

Reactions: Dyspnoea, Pneumonia, Haemoptysis, Rales, Musculoskeletal Pain, Hypotension, Pyrexia, Atrioventricular Block Second Degree, Lung Consolidation, Pulmonary Haemorrhage, Chest Pain, Tachypnoea, Pleural Effusion, Cough

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Busulfan
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-08-04
    End date: 2012-08-08

Clolar
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-08-03
    End date: 2012-08-08

Other drugs received by patient: Vancomycin; Zosyn; Micafungin; Voriconazole; Tacrolimus; Oxycodone HCL; Antibiotics; Methotrexate; Azithromycin; Neupogen; Coreg



Possible Clolar side effects in female

Reported by a physician from United States on 2012-08-16

Patient: female

Reactions: Pyrexia, Pupils Unequal, Cerebral Ischaemia, Pleural Effusion, Brain Oedema, Intracranial Pressure Increased, Staphylococcal Bacteraemia, Pupil Fixed, Blood Pressure Systolic Decreased, Pupillary Reflex Impaired, Cerebral Artery Stenosis, Brain Stem Haemorrhage, Brain Herniation, Hyperreflexia, Ascites, Convulsion, Venoocclusive Disease, Bacteraemia, Respiratory Failure, Meningitis Bacterial, Mental Disorder, Acute Myeloid Leukaemia Recurrent

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-07-12

Clolar
    Dosage: 52 mg/m2, dose level 3
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-07-13
    End date: 2012-07-17



Possible Clolar side effects in 12 year old female

Reported by a physician from Argentina on 2012-05-25

Patient: 12 year old female

Reactions: Acute Lymphocytic Leukaemia, Neutropenia, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Etoposide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-07-01

Clolar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-07-01

Cytoxan
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-07-01



Possible Clolar side effects in female

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

Patient: female, weighing 41.7 kg (91.7 pounds)

Reactions: Contusion, Skin Exfoliation, Pyrexia, Haematemesis, Oral Candidiasis, Skin Discolouration, Epistaxis, Blood Pressure Increased, Swelling Face, Stomatitis, Vomiting, Pain in Extremity, Nausea, Acute Lymphocytic Leukaemia, Renal Failure, Diarrhoea

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar

Other drugs received by patient: Promethazine; Vinorelbine; Zosyn; Linezolid; Amphojel; Meropenem; Nystatin; Norvasc; Octreotide Acetate; Dexamethasone; Vinorelbine; Caphosol; Vinorelbine; Pepcid; Zoloft; Bactrim; Caspofungin Acetate; Thiotepa; RED Blood Cells, Concentrated; Platelets; Allopurinol; Acyclovir; Solutions FOR Parenteral Nutrition; Oxycodone HCL; Neupogen; Ondansetron; Lorazepam; Zithromax; Vfend; Vancomycin; Octreotide Acetate; Topotecan; Cefepime; Imodium; Dexamethasone; D5 1 / 2 NS + KCL 20 MEQ / L; Imodium



Possible Clolar side effects in female

Reported by a physician from United States on 2012-04-11

Patient: female, weighing 41.7 kg (91.7 pounds)

Reactions: Contusion, Skin Exfoliation, Pyrexia, Haematemesis, Oral Candidiasis, Skin Discolouration, Epistaxis, Blood Pressure Increased, Swelling Face, Vomiting, Nausea, Pain in Extremity, Acute Lymphocytic Leukaemia, Mucosal Inflammation, Renal Failure, Diarrhoea

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar

Other drugs received by patient: D5 1 / 2 NS + KCL 20 MEQ / L; Vfend; Pepcid; Zoloft; Solutions FOR Parenteral Nutrition; Imodium; Thiotepa; Ondansetron; Lorazepam; Vinorelbine; Vinorelbine; Zosyn; Zithromax; Norvasc; Bactrim; Octreotide Acetate; Oxycodone HCL; Acyclovir; Caphosol; Neupogen; Promethazine; Nystatin; Platelets; Cefepime; Imodium; RED Blood Cells, Concentrated; Allopurinol; Vinorelbine; Amphojel; Meropenem; Vancomycin; Dexamethasone; Dexamethasone; Topotecan; Linezolid; Caspofungin Acetate; Octreotide Acetate



Possible Clolar side effects in male

Reported by a physician from Argentina on 2012-01-16

Patient: male

Reactions: Acute Lymphocytic Leukaemia, Neutropenia, Pyrexia

Adverse event resulted in: death

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

Etoposide
    Dosage: 150 mg/m2, unk
    Indication: Acute Lymphocytic Leukaemia

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



Possible Clolar side effects in male

Reported by a physician from Argentina on 2012-01-16

Patient: male

Reactions: Acute Lymphocytic Leukaemia, Fanconi Syndrome, Pyrexia, Neutropenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 440 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia Recurrent

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

Etoposide
    Dosage: 150 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia Recurrent



Possible Clolar side effects in male

Reported by a physician from Argentina on 2012-01-13

Patient: male

Reactions: Acute Lymphocytic Leukaemia, Fanconi Syndrome, Pyrexia, Neutropenia

Adverse event resulted in: death

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

Etoposide
    Dosage: 150 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia Recurrent

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



Possible Clolar side effects in male

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

Patient: male

Reactions: Acute Lymphocytic Leukaemia, Drug Ineffective, Neutropenia, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Etoposide
    Dosage: 150 mg/m2, qdx5, 1cycle
    Indication: Acute Lymphocytic Leukaemia

Clolar
    Dosage: 40 mg/m2, qdx5 1 cycle
    Indication: Acute Lymphocytic Leukaemia

Cyclophosphamide
    Dosage: 440 mg/m2, qdx5 1 cycle
    Indication: Acute Lymphocytic Leukaemia



Possible Clolar side effects in female

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

Patient: female

Reactions: Acute Lymphocytic Leukaemia, Neoplasm Progression, Neutropenia, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Clolar

Other drugs received by patient: Etoposide; Cyclophosphamide



Possible Clolar side effects in male

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

Patient: male

Reactions: Acute Lymphocytic Leukaemia Recurrent, Neutropenia, Pyrexia, Rash Pruritic

Adverse event resulted in: death

Drug(s) suspected as cause:
Clolar
    Dosage: 40 mg/m2, qdx5 (1 cycle)

Clolar
    Dosage: 40 mg/m2, 1 cycle
    Indication: Acute Lymphocytic Leukaemia Recurrent

Other drugs received by patient: Etoposide; Cyclophosphamide



Possible Clolar side effects in 8 year old male

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

Patient: 8 year old male, weighing 19.0 kg (41.8 pounds)

Reactions: Diarrhoea, Dysuria, Pyrexia, Staphylococcal Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: 40 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-02-01

Cyclophosphamide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Etoposide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia



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 8 year old male

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

Patient: 8 year old male, weighing 19.0 kg (41.8 pounds)

Reactions: Escherichia Test Positive, Bacteraemia, Diarrhoea, Dysuria, Pyrexia, Culture Urine Positive, Staphylococcal Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cyclosporine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Etoposide
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Clolar
    Dosage: 40 mg/m2, qdx5
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-01



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

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