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Index of reports
> Cases with Respiratory Failure (7)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Clolar (Clofarabine) where reactions include respiratory failure. 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
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:
Clolar
Dosage: 52 mg/m2, dose level 3
Indication: Bone Marrow Conditioning Regimen
Start date: 2012-07-13
End date: 2012-07-17
Cytarabine
Dosage: unk
Indication: Bone Marrow Conditioning Regimen
Start date: 2012-07-12
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 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:
Clolar
Dosage: 40 mg/m2, qdx5
Indication: Acute Lymphocytic Leukaemia
Start date: 2011-05-05
Cyclophosphamide
Dosage: 400/m2 x 5 days
Indication: Acute Lymphocytic Leukaemia
Etoposide
Dosage: 100/m2 x 5 days
Indication: Acute Lymphocytic Leukaemia
Other drugs received by patient: Dexamethasone; Hydroxyzine
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