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

 
 



Index of reports > Cases with Sepsis (15)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Clolar (Clofarabine) where reactions include sepsis. 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:
Clolar
    Dosage: 74.4 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-19
    End date: 2012-06-23

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

Epinephrine
    Dosage: 4 df, unk
    Indication: Cardiac Arrest
    Start date: 2012-07-14
    End date: 2012-07-14

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

Etoposide
    Dosage: unk
    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

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 female

Reported by a physician from United States on 2012-08-21

Patient: female, weighing 25.0 kg (55.0 pounds)

Reactions: Ischaemia, Pulmonary Alveolar Haemorrhage, Pericardial Effusion, Renal Failure, Cardiac Failure, Respiratory Failure, Sepsis, Pleural Effusion, Hypertension, Fusarium Infection

Adverse event resulted in: death, life threatening event, disablity

Drug(s) suspected as cause:
Clolar
    Dosage: 70 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-10
    End date: 2012-01-11

Fludara
    Dosage: 140 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-11
    End date: 2012-06-15

Mozobil
    Dosage: 6 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-16
    End date: 2012-06-18

Thymoglobulin
    Dosage: 254 mg, qd
    Start date: 2012-06-16
    End date: 2012-06-19

Thymoglobulin
    Dosage: 229.9 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-15
    End date: 2012-01-18

Other drugs received by patient: Meropenem; Fentanyl Citrate; Cytarabine; Thiotepa; Melphalan Hydrochloride; Dilaudid; Busulfan



Possible Clolar side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female, weighing 25.0 kg (55.0 pounds)

Reactions: Ischaemia, Pulmonary Alveolar Haemorrhage, Pericardial Effusion, Renal Failure, Respiratory Failure, Cardiac Failure, Sepsis, Pleural Effusion, Fusarium Infection, Hypertension

Adverse event resulted in: death, life threatening event, disablity

Drug(s) suspected as cause:
Clolar
    Dosage: 70 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-10
    End date: 2012-01-11

Fludara
    Dosage: 140 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-11
    End date: 2012-06-15

Mozobil
    Dosage: 6 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-16
    End date: 2012-06-18

Thymoglobulin
    Dosage: 229.9 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-15
    End date: 2012-01-18

Thymoglobulin
    Dosage: 254 mg, qd
    Start date: 2012-06-16
    End date: 2012-06-19

Other drugs received by patient: Busulfan; Thiotepa; Dilaudid; Meropenem; Cytarabine; Melphalan Hydrochloride; Fentanyl Citrate



Possible Clolar side effects in female

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

Patient: female, weighing 25.2 kg (55.4 pounds)

Reactions: Ischaemia, Pulmonary Alveolar Haemorrhage, Pericardial Effusion, Renal Failure, Cardiac Failure, Respiratory Failure, Sepsis, Pleural Effusion, Fusarium Infection, Hypertension

Adverse event resulted in: death, life threatening event, disablity

Drug(s) suspected as cause:
Clolar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-10
    End date: 2012-01-11

Fludara
    Dosage: 140 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-11
    End date: 2012-06-15

Mozobil
    Dosage: 6 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-16
    End date: 2012-06-18

Thymoglobulin
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-15
    End date: 2012-01-18

Thymoglobulin
    Dosage: unk
    Start date: 2012-06-16
    End date: 2012-06-19

Other drugs received by patient: Melphalan Hydrochloride; Busulfan; Fentanyl; Thiotepa; Cytarabine; Dilaudid; Meropenem



Possible Clolar side effects in female

Reported by a physician from United States on 2012-08-13

Patient: female, weighing 25.2 kg (55.4 pounds)

Reactions: Ischaemia, Pulmonary Alveolar Haemorrhage, Pericardial Effusion, Renal Failure, Respiratory Failure, Cardiac Failure, Sepsis, Pleural Effusion, Fusarium Infection, Hypertension

Adverse event resulted in: death, life threatening event, disablity

Drug(s) suspected as cause:
Clolar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-10
    End date: 2012-01-11

Fludara
    Dosage: 140 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-11
    End date: 2012-06-15

Mozobil
    Dosage: 6 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-16
    End date: 2012-06-18

Thymoglobulin
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-15
    End date: 2012-01-18

Thymoglobulin
    Dosage: unk
    Start date: 2012-06-16
    End date: 2012-06-19

Other drugs received by patient: Meropenem; Melphalan Hydrochloride; Cytarabine; Busulfan; Dilaudid; Fentanyl; Thiotepa



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 11 year old male

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

Patient: 11 year old male

Reactions: Multi-Organ Failure, Cardiac Failure, Hypotension, Sepsis, Electrolyte Imbalance

Adverse event resulted in: death

Drug(s) suspected as cause:
Clolar
    Dosage: unk

Clolar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Cyclophosphamide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Cyclophosphamide
    Dosage: unk

Etoposide
    Dosage: unk

Etoposide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia



Possible Clolar side effects in 62 year old male

Reported by a physician from United States on 2012-03-28

Patient: 62 year old male, weighing 71.0 kg (156.2 pounds)

Reactions: Multi-Organ Failure, Sepsis, Acute Myeloid Leukaemia, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: 37.2 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-01-24

Clolar
    Dosage: 37.2 mg, unk
    Start date: 2012-02-17
    End date: 2012-02-17



Possible Clolar side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-28

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Transfusion-Related Acute Lung Injury, Sepsis, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: 20 mg/m2, qdx5 consolidation
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-01-23
    End date: 2012-01-27

Clolar
    Dosage: cycle ii of induction
    Start date: 2011-10-25
    End date: 2011-10-28

Clolar
    Dosage: cycle i of induction
    Start date: 2011-10-04
    End date: 2011-10-08

Other drugs received by patient: Ciprofloxacin HCL; Voriconazole; Oxycodone HCL; Ondansetron; Ondansetron; Compazine; Compazine



Possible Clolar side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Transfusion-Related Acute Lung Injury, Sepsis, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: 20 mg/m2, qdx5 consolidation
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-01-23
    End date: 2012-01-27

Clolar
    Dosage: cycle i of induction
    Start date: 2011-10-04
    End date: 2011-10-08

Clolar
    Dosage: cycle ii of induction
    Start date: 2011-10-25
    End date: 2011-10-28

Other drugs received by patient: Voriconazole; Ondansetron; Ondansetron; Compazine; Oxycodone HCL; Compazine; Ciprofloxacin Hydrochloride



Possible Clolar side effects in male

Reported by a physician from United States on 2012-03-06

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Transfusion-Related Acute Lung Injury, Sepsis, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar



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

Cyclophosphamide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Etoposide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Other drugs received by patient: Fluconazole; Ciprofloxacin



Possible Clolar side effects in 17 year old male

Reported by a physician from Argentina on 2011-12-01

Patient: 17 year old male

Reactions: Grand MAL Convulsion, Sepsis, Neutropenia, Status Epilepticus, Erythema

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: 40 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia Recurrent
    Start date: 2011-10-24
    End date: 2011-10-28

Cyclophosphamide
    Dosage: 440 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia Recurrent
    Start date: 2011-10-24
    End date: 2011-10-28

Etoposide
    Dosage: 100 mg/m2, qdx5
    Indication: Acute Lymphocytic Leukaemia Recurrent
    Start date: 2011-10-24
    End date: 2011-10-28

Other drugs received by patient: Acetaminophen; Benadryl



Possible Clolar side effects in 6 year old female

Reported by a physician from Argentina on 2011-10-17

Patient: 6 year old female

Reactions: Death, Sepsis, Haematotoxicity

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: 40 mg/m2, qdx5 (cycle 1)
    Indication: Acute Lymphocytic Leukaemia Recurrent
    Start date: 2010-11-02

Clolar
    Dosage: 40 mg/m2, qdx5 (cycle 2)

Cyclophosphamide
    Dosage: unk (cycle 1)
    Indication: Acute Lymphocytic Leukaemia Recurrent
    Start date: 2010-11-02

Cyclophosphamide
    Dosage: unk (cycle 2)

Etoposide
    Dosage: unk (cycle 1)
    Indication: Acute Lymphocytic Leukaemia Recurrent
    Start date: 2010-11-02

Etoposide
    Dosage: unk (cycle 2)



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

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