CLOLAR Side Effects

6814605-1 | Febrile Neutropenia, Leukopenia, Pancytopenia, Sepsis
on Jun 23, 2010 Male patient from SOUTH AFRICA , weighting 187.4 lb, was diagnosed with acute lymphocytic leukaemia, prophylaxis, fungal infection (What is fungal infection?), haemorrhage, nausea (What is nausea?) and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: febrile neutropenia, leukopenia, pancytopenia, sepsis (What is sepsis?). Clolar dosage: 50 Mg/m2, Qdx5. During the same period patient was treated with CYCLOPHOSPHAMIDE (400 Mg/m2, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ), ETOPOSIDE (150 Mg/m2, Qdx5) (View Etoposide Review and Etoposide Label ), ACYCLOVIR (200 Mg, Tid) (View Acyclovir Review and Acyclovir Label ), AMPHOTERICIN B (50 Mg, Qd) (View Amphotericin B Review and Amphotericin B Label ), OESTROGEN (25 Mg, Unk) (View Oestrogen Review and Oestrogen Label ), DOLASETRON (100 Mg, Qd) (View Dolasetron Review and Dolasetron Label ), FOLIC ACID (5 Mg, Qd) (View Folic Acid Review and Folic Acid Label ).

6797992-2 | Renal Failure
Patient was taking Clolar (View Usage). Patient had the following side effects: renal failure on Jun 09, 2010 from UNITED STATES Additional patient health information: Male patient , 45 years of age, was diagnosed with haematological malignancy and. Clolar dosage: 40 Mg/m2, Qdx5, Intravenous. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (140 Mg/m2, Qdx2,) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), CAMPATH (20 Mg) (View Campath Review and Campath Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ).

6784848-4 | Candidiasis
Adverse event was reported on Apr 27, 2010 by a Male patient taking Clolar (View Usage) (Dosage: ) was diagnosed with acute leukaemia and. Location: MEXICO , 23 years of age, After Clolar was administered, patient had the following side effects: candidiasis.

6784845-9 | Neutropenia, Sepsis
on Nov 19, 2009 Female patient from UNITED STATES , weighting 114.9 lb, was diagnosed with acute leukaemia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: neutropenia, sepsis (What is sepsis?). Clolar dosage: 60 Mg, Qdx5. During the same period patient was treated with CELEXA (20 Mg, Qd) (View Celexa Review and Celexa Label ), FLUCONAZOLE (200 Mg, Qd) (View Fluconazole Review and Fluconazole Label ), REGLAN (10 Mg, Qid) (View Reglan Review and Reglan Label ).


6784834-4 | Caecitis, Fungal Sepsis, Multi-organ Failure, Neutropenia
on May 27, 2009 Male patient from UNITED STATES , 16 years of age, weighting 154.5 lb, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). Patient had the following side effects: caecitis, fungal sepsis, multi-organ failure, neutropenia. Clolar dosage: Unk Unk, Unk. During the same period patient was treated with GEMTUZUMAB (Unk Unk, Unk) (View Gemtuzumab Review and Gemtuzumab Label ), CLADRIBINE (17 Mg, Unk) (View Cladribine Review and Cladribine Label ), CYTARABINE (920 Mg, Unk) (View Cytarabine Review and Cytarabine Label ).

6782274-5 | Dyspnoea, Hypotension, Pulmonary Oedema, Respiratory Failure, Tumour Lysis Syndrome
Patient was taking Clolar (View Usage). After Clolar was administered, patient had the following side effects: dyspnoea, hypotension, pulmonary oedema, respiratory failure, tumour lysis syndrome on Jun 10, 2010 from CANADA Additional patient health information: Male patient , weighting 159.4 lb, was diagnosed with acute lymphocytic leukaemia, prophylaxis, septic shock, nausea (What is nausea?), oral herpes, fluid overload and. Clolar dosage: 100 Mg, Qd. During the same period patient was treated with SOLU CORTEF (80 Mg, Qd) (View Solu-cortef Review and Solu-cortef Label ), ALLOPURINOL (200 Mg, Qd) (View Allopurinol Review and Allopurinol Label ), MEROPENEM (500 Mg, Qid) (View Meropenem Review and Meropenem Label ), VORICONAZOLE (200 Mg, Bid) (View Voriconazole Review and Voriconazole Label ), VANCOMYCIN (1 G, Bid) (View Vancomycin Review and Vancomycin Label ), ZOFRAN (8 Mg, Tid) (View Zofran Review and Zofran Label ), VALACYCLOVIR (500 Mg, Tid) (View Valacyclovir Review and Valacyclovir Label ), LASIX (20 Mg, Tid) (View Lasix Review and Lasix Label ).

6770488-X |
Adverse event was reported on Apr 13, 2010 by a Male patient taking Clolar (View Usage) (Dosage: Unk) was diagnosed with myelodysplastic syndrome and. Location: UNITED STATES , weighting 198.9 lb, .

6767870-3 | Depressed Level Of Consciousness
on Jun 04, 2010 Male patient from UNITED STATES , child 7 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). Patient had the following side effects: depressed level of consciousness. Clolar dosage: 52 Mg/m2, Qdx5. During the same period patient was treated with CYTARABINE (Unk Unk, Unk) (View Cytarabine Review and Cytarabine Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ).

6762326-6 | Febrile Neutropenia, Sepsis
on May 27, 2010 Male patient from SOUTH AFRICA , weighting 187.4 lb, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: febrile neutropenia, sepsis (What is sepsis?). Clolar dosage: 50 Mg/m2, Qdx5. During the same period patient was treated with CYCLOPHOSPHAMIDE (400 Mg/m2, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ), ETOPOSIDE (150 Mg/m2, Qdx5) (View Etoposide Review and Etoposide Label ).

6757916-0 | Emphysema, Pneumonitis, Pneumothorax Spontaneous Tension, Pulmonary Hypertension, Pulmonary Veno-occlusive Disease
Patient was taking Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: emphysema, pneumonitis, pneumothorax spontaneous tension, pulmonary hypertension (What is pulmonary hypertension?), pulmonary veno-occlusive disease on May 24, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 20.50 lb, was diagnosed with acute leukaemia, antiviral prophylaxis, antifungal prophylaxis, prophylaxis against graft versus host disease and. Clolar dosage: 19.8 Mg, Qdx5. During the same period patient was treated with GANCICLOVIR (45 Mg, Unk) (View Ganciclovir Review and Ganciclovir Label ), MICAFUNGIN (26 Mg, Unk) (View Micafungin Review and Micafungin Label ), PENTAMIDINE ISETHIONATE (37 Mg, Unk) (View Pentamidine Isethionate Review and Pentamidine Isethionate Label ), IMMUNE GLOBULIN NOS (5 G, Unk) (View Immune Globulin Nos Review and Immune Globulin Nos Label ), FOSCARNET (820 Mg, Unk) (View Foscarnet Review and Foscarnet Label ), MYCOPHENOLATE MOFETIL (270 Mg, Unk) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), CYTOGAM (3600 Mg, Unk) (View Cytogam Review and Cytogam Label ).

6754481-9 | Bradycardia, Cardiac Failure Congestive, Cardio-respiratory Arrest, Chest Pain, Confusional State, Dyspnoea, Fall, Hypotension, Hypoxia
Adverse event was reported on May 17, 2010 by a Female patient taking Clolar (View Usage) (Dosage: 30 Mg/m2, Qd, Intravenous) was diagnosed with leukaemia and. Location: UNITED STATES , 56 years of age, weighting 156.1 lb, Patient had the following side effects: bradycardia, cardiac failure congestive, cardio-respiratory arrest, chest pain (What is chest pain?), confusional state, dyspnoea, fall (What is fall?), hypotension, hypoxia. During the same period patient was treated with CAMPATH (20 Mg, Qd, Intravenous) (View Campath Review and Campath Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), PREVACID (View Prevacid Review and Prevacid Label ), ZOLOFT (View Zoloft Review and Zoloft Label ), VANCOMYCIN (View Vancomycin Review and Vancomycin Label ), AZTREONAM (AZTREONAM) (View Aztreonam (aztreonam) Review and Aztreonam (aztreonam) Label ), GANCICLOVIR (View Ganciclovir Review and Ganciclovir Label ), FLAGYL (View Flagyl Review and Flagyl Label ).

6754480-7 | Acidosis, Acute Myeloid Leukaemia, Ascites, Bacillus Infection, Bradycardia, Cardiac Arrest, Cardiopulmonary Failure, Continuous Haemodiafiltration, Disease Complication
on May 17, 2010 Male patient from UNITED STATES , 51 years of age, weighting 160.9 lb, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: acidosis, acute myeloid leukaemia, ascites, bacillus infection, bradycardia, cardiac arrest (What is cardiac arrest?), cardiopulmonary failure, continuous haemodiafiltration, disease complication. Clolar dosage: 54 Mg, Qdx5, Intravenous. During the same period patient was treated with CAMPATH (20 Mg, Qdx5, Intravenous) (View Campath Review and Campath Label ), ANTIBIOTICS (View Antibiotics Review and Antibiotics Label ), ANTIFUNGALS (View Antifungals Review and Antifungals Label ).

6754433-9 | Renal Failure
on May 17, 2010 Female patient from UNITED STATES , 45 years of age, was diagnosed with haematological malignancy and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: renal failure. Clolar dosage: 40 Mg/m2, Qdx5, Intravenous. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (140 Mg/m2, Qdx2) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), CAMPATH (20 Mg) (View Campath Review and Campath Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ).

6745829-X | Acute Myeloid Leukaemia, Hepatosplenomegaly, Sepsis, Septic Shock
Patient was taking Clolar (View Usage). Patient had the following side effects: acute myeloid leukaemia, hepatosplenomegaly, sepsis (What is sepsis?), septic shock on May 17, 2010 from UNITED STATES Additional patient health information: Male patient , weighting 172.0 lb, was diagnosed with acute myeloid leukaemia and. Clolar dosage: 20 Mg/m2, Qdx5. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (190 Mg, Once) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), CAMPATH (20 Mg, Qdx5) (View Campath Review and Campath Label ), NEUPOGEN (480 Unk, Unk) (View Neupogen Review and Neupogen Label ), PROGRAF (2.2 Unk, Unk) (View Prograf Review and Prograf Label ), ZYPREXA (Unk Unk, Unk) (View Zyprexa Review and Zyprexa Label ), LEVOPHED (Unk Unk, Unk) (View Levophed Review and Levophed Label ), VASOPRESSIN (Unk Unk, Unk) (View Vasopressin Review and Vasopressin Label ), DAPTOMYCIN (450 Unk, Unk) (View Daptomycin Review and Daptomycin Label ).

6742371-7 | Multi-organ Failure, Renal Failure, Sepsis
Adverse event was reported on Apr 20, 2010 by a Female patient taking Clolar (View Usage) (Dosage: 40 Unk, Unk) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , 59 years of age, After Clolar was administered, patient had the following side effects: multi-organ failure, renal failure, sepsis (What is sepsis?). During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Unk Unk, Unk) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), ALEMTUZUMAB (Unk Unk, Unk) (View Alemtuzumab Review and Alemtuzumab Label ).

6741451-X | Thrombocytopenia
on May 12, 2010 Male patient from UNITED STATES , weighting 199.0 lb, was diagnosed with myelodysplastic syndrome, infection prophylaxis, hypothyroidism, hypertension, hyperlipidaemia, gastrooesophageal reflux disease, insomnia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: thrombocytopenia. Clolar dosage: 5 Mg/m2, Qdx5. During the same period patient was treated with LEVAQUIN (500 Mg, Qd) (View Levaquin Review and Levaquin Label ), SYNTHROID (125 Mcg, Qd) (View Synthroid Review and Synthroid Label ), TOPROL XL (50 Mg, Qd) (View Toprol-xl Review and Toprol-xl Label ), VYTORIN (1 Unk, Qd, 10/20) (View Vytorin Review and Vytorin Label ), PROTONIX (40 Mg, Qd) (View Protonix Review and Protonix Label ), DIOVAN (View Diovan Review and Diovan Label ), AMBIEN (10 Mg, Qd) (View Ambien Review and Ambien Label ).

6736508-3 | Confusional State, Failure To Thrive, Pneumonia Aspiration, Respiratory Failure, Sepsis
on Apr 20, 2010 Female patient from UNITED STATES , 73 years of age, was diagnosed with myelodysplastic syndrome and was treated with Clolar (View Usage). Patient had the following side effects: confusional state, failure to thrive, pneumonia aspiration, respiratory failure, sepsis (What is sepsis?). Clolar dosage: 30 Unk, Unk. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Unk Unk, Unk) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), ALEMTUZUMAB (Unk Unk, Unk) (View Alemtuzumab Review and Alemtuzumab Label ).

6736493-4 | Arrhythmia, Cardiac Failure Congestive
Patient was taking Clolar (View Usage). After Clolar was administered, patient had the following side effects: arrhythmia (What is arrhythmia?), cardiac failure congestive on Apr 20, 2010 from UNITED STATES Additional patient health information: Female patient , 68 years of age, was diagnosed with acute myeloid leukaemia and. Clolar dosage: 40 Unk, Unk. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Unk Unk, Unk) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), ALEMTUZUMAB (Unk Unk, Unk) (View Alemtuzumab Review and Alemtuzumab Label ).

6736471-5 | Dementia, Multi-organ Failure, Renal Failure
Adverse event was reported on Apr 20, 2010 by a Female patient taking Clolar (View Usage) (Dosage: 30 Unk, Unk) was diagnosed with myelodysplastic syndrome and. Location: UNITED STATES , 62 years of age, Patient experienced the following unwanted or unexpected effects: dementia (What is dementia?), multi-organ failure, renal failure. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Unk Unk, Unk) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), ALEMTUZUMAB (Unk Unk, Unk) (View Alemtuzumab Review and Alemtuzumab Label ).

6736452-1 | Delirium, Multi-organ Failure, Renal Failure
on Apr 20, 2010 Female patient from UNITED STATES , 64 years of age, was diagnosed with myeloproliferative disorder and was treated with Clolar (View Usage). Patient had the following side effects: delirium, multi-organ failure, renal failure. Clolar dosage: 25 Unk, Unk. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Unk Unk, Unk) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), ALEMTUZUMAB (Unk Unk, Unk) (View Alemtuzumab Review and Alemtuzumab Label ).

6736349-7 | Cardiac Failure Congestive, Renal Failure
on Apr 20, 2010 Female patient from UNITED STATES , 67 years of age, was diagnosed with myelodysplastic syndrome and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: cardiac failure congestive, renal failure. Clolar dosage: 30 Unk, Unk. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Unk Unk, Unk) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), ALEMTUZUMAB (Unk Unk, Unk) (View Alemtuzumab Review and Alemtuzumab Label ).

6736257-1 | Hepatic Failure, Renal Failure
Patient was taking Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: hepatic failure, renal failure on Apr 20, 2010 from UNITED STATES Additional patient health information: Female patient , 65 years of age, was diagnosed with lymphoma (What is lymphoma?) and. Clolar dosage: 40 Unk, Unk. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Unk Unk, Unk) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), ALEMTUZUMAB (Unk Unk, Unk) (View Alemtuzumab Review and Alemtuzumab Label ).

6725595-4 | Gastrointestinal Fungal Infection
Adverse event was reported on May 03, 2010 by a Male patient taking Clolar (View Usage) (Dosage: Unk Unk, Unk) was diagnosed with acute lymphocytic leukaemia and. Location: CHINA , 38 years of age, Patient had the following side effects: gastrointestinal fungal infection.

6721471-1 | Cardiomegaly, Lung Infiltration, Neutropenia, Pain, Pneumonia, Pulmonary Oedema, Respiratory Disorder
on May 03, 2010 Male patient from BRAZIL , child 11 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: cardiomegaly, lung infiltration, neutropenia, pain (What is pain?), pneumonia (What is pneumonia?), pulmonary oedema, respiratory disorder. Clolar dosage: 60 Mg, Qd. Patient was hospitalized.

6712855-6 | Acute Lymphocytic Leukaemia Recurrent, Bronchopulmonary Aspergillosis, Dysarthria, Dysphagia, Neutropenic Sepsis, Septic Shock
on Mar 20, 2009 Male patient from SINGAPORE , weighting 137.3 lb, was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: acute lymphocytic leukaemia recurrent, bronchopulmonary aspergillosis, dysarthria, dysphagia, neutropenic sepsis, septic shock. Clolar dosage: 10 Mg/m2, Qd. During the same period patient was treated with CYCLOPHOSPHAMIDE (250 Mg/m2, Qd) (View Cyclophosphamide Review and Cyclophosphamide Label ). Patient was hospitalized.

6707029-9 | Disease Progression, Gamma-glutamyltransferase Increased, Hypokalaemia
Patient was taking Clolar (View Usage). Patient had the following side effects: disease progression, gamma-glutamyltransferase increased, hypokalaemia on Apr 21, 2010 from UNITED STATES Additional patient health information: Male patient , child 4 years of age, weighting 33.51 lb, was diagnosed with acute lymphocytic leukaemia and. Clolar dosage: 52 Mg/m2, Qdx5. During the same period patient was treated with CYTARABINE (1 G/m2, Qdx5) (View Cytarabine Review and Cytarabine Label ).

6706878-0 | Alanine Aminotransferase Increased, Blood Bilirubin Increased, Encephalopathy, Hyponatraemia, Hypophosphataemia, Lymphopenia, Neutropenia, Psychotic Disorder, Retrograde Portal Vein Flow
Adverse event was reported on Apr 20, 2010 by a Female patient taking Clolar (View Usage) (Dosage: 20 Mg, Qd) was diagnosed with acute myeloid leukaemia, sepsis (What is sepsis?) and. Location: UNITED STATES , weighting 235.2 lb, After Clolar was administered, patient had the following side effects: alanine aminotransferase increased, blood bilirubin increased, encephalopathy, hyponatraemia, hypophosphataemia, lymphopenia, neutropenia, psychotic disorder (What is psychotic disorder?), retrograde portal vein flow. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN (3 Mg/m2, Unk) (View Gemtuzumab Ozogamicin Review and Gemtuzumab Ozogamicin Label ), VANCOMYCIN (1 G, Tid) (View Vancomycin Review and Vancomycin Label ), MICAFUNGIN (100 Mg, Qd) (View Micafungin Review and Micafungin Label ), VALACICLOVIR (500 Mg, Qd) (View Valaciclovir Review and Valaciclovir Label ).

6706761-0 | Blood Alkaline Phosphatase Increased, Gamma-glutamyltransferase Increased, Hypocalcaemia, Lymphopenia, Neutropenia, Sepsis, Thrombocytopenia
on Apr 20, 2010 Female patient from UNITED STATES , weighting 150.1 lb, was diagnosed with acute myeloid leukaemia, sepsis (What is sepsis?) and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: blood alkaline phosphatase increased, gamma-glutamyltransferase increased, hypocalcaemia, lymphopenia, neutropenia, sepsis (What is sepsis?), thrombocytopenia. Clolar dosage: 20 Mg, Qd. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN (3 Mg/m2, Qd) (View Gemtuzumab Ozogamicin Review and Gemtuzumab Ozogamicin Label ), VANCOMYCIN (1 G, Tid) (View Vancomycin Review and Vancomycin Label ), MICAFUNGIN (100 Mg, Qd) (View Micafungin Review and Micafungin Label ), AMBISOME (340 Mg, Qd) (View Ambisome Review and Ambisome Label ).

6703422-9 | Renal Failure
on Apr 20, 2010 Male patient from UNITED STATES , 68 years of age, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). Patient had the following side effects: renal failure. Clolar dosage: 30 Mg/m2, Qdx5. During the same period patient was treated with ALLOPURINOL (View Allopurinol Review and Allopurinol Label ).

6703386-8 | Acidosis, Aspartate Aminotransferase Increased, Dyspnoea, Infection, Left Ventricular Dysfunction, Neutropenia, Sepsis, Somnolence, Thrombocytopenia
Patient was taking Clolar (View Usage). After Clolar was administered, patient had the following side effects: acidosis, aspartate aminotransferase increased, dyspnoea, infection (What is infection?), left ventricular dysfunction, neutropenia, sepsis (What is sepsis?), somnolence, thrombocytopenia on Apr 20, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 152.3 lb, was diagnosed with acute myeloid leukaemia, prophylaxis, sepsis (What is sepsis?) and. Clolar dosage: 20 Mg, Unk. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN (3 Mg/m2, Unk) (View Gemtuzumab Ozogamicin Review and Gemtuzumab Ozogamicin Label ), VALTREX (500 Mg, Qd) (View Valtrex Review and Valtrex Label ), MICAFUNGIN (100 Mg, Qd) (View Micafungin Review and Micafungin Label ), DAPTOMYCIN (400 Mg, Qd) (View Daptomycin Review and Daptomycin Label ).

6696877-X |
Adverse event was reported on Apr 13, 2010 by a Male patient taking Clolar (View Usage) (Dosage: Unk) was diagnosed with myelodysplastic syndrome and. Location: UNITED STATES , weighting 198.9 lb, .

6680950-6 | Appendicitis, Device Related Infection, Febrile Neutropenia, Gastrointestinal Fungal Infection
on Apr 05, 2010 Female patient from UNITED STATES , weighting 59.75 lb, was diagnosed with acute myeloid leukaemia, goitre, blood fibrinogen decreased and was treated with Clolar (View Usage). Patient had the following side effects: appendicitis (What is appendicitis?), device related infection, febrile neutropenia, gastrointestinal fungal infection. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with TOPOTECAN (1 Mg/m2, Qdx5) (View Topotecan Review and Topotecan Label ), VINORELBINE (2 Mg/m2, Qd) (View Vinorelbine Review and Vinorelbine Label ), THIOTEPA (15 Mg/m2, Qd) (View Thiotepa Review and Thiotepa Label ), DEXAMETHASONE (Unk Unk, Unk) (View Dexamethasone Review and Dexamethasone Label ), SYNTHROID (Unk Unk, Unk) (View Synthroid Review and Synthroid Label ), FRESH FROZEN PLASMA (Unk Unk, Unk) (View Fresh Frozen Plasma Review and Fresh Frozen Plasma Label ).

6679382-6 | Agitation, Aplasia, Cerebrovascular Accident, Insomnia, Leukopenia, Palmar-plantar Erythrodysaesthesia Syndrome, Pancytopenia
on Apr 01, 2010 Female patient from BRAZIL , child 9 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: agitation, aplasia, cerebrovascular accident, insomnia, leukopenia, palmar-plantar erythrodysaesthesia syndrome, pancytopenia. Clolar dosage: Unk Unk, Unk. During the same period patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (View Diphenhydramine Hydrochloride Review and Diphenhydramine Hydrochloride Label ).

6674236-3 | Cholecystitis Acute, Fungal Infection, Mental Status Changes, Renal Failure Acute, Sepsis
Patient was taking Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: cholecystitis acute, fungal infection (What is fungal infection?), mental status changes, renal failure acute, sepsis (What is sepsis?) on Mar 30, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 278.4 lb, was diagnosed with acute myeloid leukaemia and. Clolar dosage: 10 Mg/m2, Qdx5. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN (3 Mg/m2, Days 1,4,7) (View Gemtuzumab Ozogamicin Review and Gemtuzumab Ozogamicin Label ). Patient was hospitalized.

6663790-3 | Acute Respiratory Distress Syndrome, Bacteraemia, Blood Amylase Increased, Colitis, Hypotension, Lipase Increased, Lung Infection
Adverse event was reported on Mar 23, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 40 Mg/m2, Qdx5 Days 3-7) was diagnosed with acute leukaemia and. Location: UNITED STATES , 16 years of age, Patient had the following side effects: acute respiratory distress syndrome, bacteraemia, blood amylase increased, colitis, hypotension, lipase increased, lung infection. During the same period patient was treated with TOPOTECAN (1 Mg/m2, Qd, Day 0-4) (View Topotecan Review and Topotecan Label ), VINORELBINE (20 Mg/m2, Qw, Days 0, 7, And 14) (View Vinorelbine Review and Vinorelbine Label ), THIOTEPA (15 Mg/m2, Once, Day 2) (View Thiotepa Review and Thiotepa Label ), DEXAMETHASONE (45 Mg/m2, Tid X7 Days) (View Dexamethasone Review and Dexamethasone Label ), GRANULOCYTE COLONY STIMULATING FACTOR (5 Mcg/kg, Qd) (View Granulocyte Colony Stimulating Factor Review and Granulocyte Colony Stimulating Factor Label ), ARA C (70 Mg, Once) (View Ara-c Review and Ara-c Label ).

6651437-1 | Agitation, Aplasia, Insomnia, Leukopenia, Palmar-plantar Erythrodysaesthesia Syndrome, Pancytopenia
on Mar 15, 2010 Female patient from BRAZIL , child 9 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: agitation, aplasia, insomnia, leukopenia, palmar-plantar erythrodysaesthesia syndrome, pancytopenia. Clolar dosage: Unk Unk, Unk. During the same period patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (View Diphenhydramine Hydrochloride Review and Diphenhydramine Hydrochloride Label ).

6651017-8 | Aortic Thrombosis, Blood Creatine Phosphokinase Increased, Cerebellar Haemorrhage, Platelet Count Decreased, Pulmonary Oedema
on Mar 11, 2010 Male patient from UNITED STATES , 67 years of age, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: aortic thrombosis, blood creatine phosphokinase increased, cerebellar haemorrhage, platelet count decreased, pulmonary oedema. Clolar dosage: 20 Mg/m2, Qdx5, Intravenous. During the same period patient was treated with CYTARABINE (100 Mg/m2, Qd, 24 Hr. Continuous, Intravenous) (View Cytarabine Review and Cytarabine Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), TPN (View Tpn Review and Tpn Label ), VORICONAZOLE (View Voriconazole Review and Voriconazole Label ), ACYCLOVIR (View Acyclovir Review and Acyclovir Label ), LASIX (View Lasix Review and Lasix Label ), IMPENEM (IMIPENEM) (View Impenem (imipenem) Review and Impenem (imipenem) Label ).

6632153-9 | Acidosis, Aspartate Aminotransferase Increased, Dyspnoea, Infection, Left Ventricular Dysfunction, Neutropenia, Somnolence, Thrombocytopenia
Patient was taking Clolar (View Usage). Patient had the following side effects: acidosis, aspartate aminotransferase increased, dyspnoea, infection (What is infection?), left ventricular dysfunction, neutropenia, somnolence, thrombocytopenia on Mar 01, 2010 from UNITED STATES Additional patient health information: Female patient , 51 years of age, was diagnosed with acute myeloid leukaemia and. Clolar dosage: 20 Mg, Unk. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN (Unk Unk, Unk) (View Gemtuzumab Ozogamicin Review and Gemtuzumab Ozogamicin Label ).

6631708-5 | Alanine Aminotransferase Increased, Blood Bilirubin Increased, Encephalopathy, Hyponatraemia, Hypophosphataemia, Lymphopenia, Neutropenia, Psychotic Disorder, Retrograde Portal Vein Flow
Adverse event was reported on Mar 01, 2010 by a Female patient taking Clolar (View Usage) (Dosage: 20 Mg, Unk) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , 38 years of age, After Clolar was administered, patient had the following side effects: alanine aminotransferase increased, blood bilirubin increased, encephalopathy, hyponatraemia, hypophosphataemia, lymphopenia, neutropenia, psychotic disorder (What is psychotic disorder?), retrograde portal vein flow. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN (Unk Unk, Unk) (View Gemtuzumab Ozogamicin Review and Gemtuzumab Ozogamicin Label ).

6631647-X | Blood Alkaline Phosphatase Increased, Gamma-glutamyltransferase Increased, Hypocalcaemia, Lymphopenia, Neutropenia, Thrombocytopenia
on Mar 01, 2010 Female patient from UNITED STATES , 21 years of age, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: blood alkaline phosphatase increased, gamma-glutamyltransferase increased, hypocalcaemia, lymphopenia, neutropenia, thrombocytopenia. Clolar dosage: 20 Mg, Unk. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN (Unk Unk, Unk) (View Gemtuzumab Ozogamicin Review and Gemtuzumab Ozogamicin Label ).

6627784-6 | Aspartate Aminotransferase Increased, Atrial Fibrillation, Cough, Engraftment Syndrome, Epistaxis, Fluid Overload, Gastrooesophageal Reflux Disease, Haemorrhagic Stroke, Hypocalcaemia
on Feb 22, 2010 Female patient from UNITED STATES , 65 years of age, weighting 141.8 lb, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). Patient had the following side effects: aspartate aminotransferase increased, atrial fibrillation (What is atrial fibrillation?), cough, engraftment syndrome, epistaxis, fluid overload, gastrooesophageal reflux disease, haemorrhagic stroke, hypocalcaemia. Clolar dosage: 40 Mg/m2, Qdx5, Intravenous. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (140 Mg/m2, Once, Intravenous) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), SIROLIMUS (RAPAMUNE) (View Sirolimus (rapamune) Review and Sirolimus (rapamune) Label ). Patient was hospitalized.

6596944-5 | Aortic Thrombosis, Haemorrhage, Nervous System Disorder
Patient was taking Clolar (View Usage). After Clolar was administered, patient had the following side effects: aortic thrombosis, haemorrhage, nervous system disorder on Feb 01, 2010 from UNITED STATES Additional patient health information: Male patient , 67 years of age, was diagnosed with acute myeloid leukaemia and. Clolar dosage: 20 Mg/m2, Qdx5, Intravenous. During the same period patient was treated with CYTARABINE (100 Mg/m2, Qd 24 Hr. Continuous, Intravenous) (View Cytarabine Review and Cytarabine Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), TPN (NICOTANAMIDE, PYRIDOXINE HYDROCHLORIDE, TYROSINE) (View Tpn (nicotanamide, Pyridoxine Hydrochloride, Tyrosine) Review and Tpn (nicotanamide, Pyridoxine Hydrochloride, Tyrosine) Label ), VORICONAZOLE (View Voriconazole Review and Voriconazole Label ), ACYCLOVIR (View Acyclovir Review and Acyclovir Label ), LASIX (View Lasix Review and Lasix Label ), IMIPENEM (IMIPENEM) (View Imipenem (imipenem) Review and Imipenem (imipenem) Label ).

6592858-5 | Alanine Aminotransferase Increased, Convulsion, Disease Progression, Klebsiella Sepsis, Neutropenic Colitis, Non-hodgkin's Lymphoma, Pneumatosis Intestinalis, Respiratory Distress, White Blood Cell Count Decreased
Adverse event was reported on Feb 04, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 40 Mg/m2, Qdx5, Intravenous) was diagnosed with t-cell lymphoma refractory and. Location: SINGAPORE , child 4 years of age, weighting 35.27 lb, Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, convulsion, disease progression, klebsiella sepsis, neutropenic colitis, non-hodgkin's lymphoma, pneumatosis intestinalis, respiratory distress, white blood cell count decreased. During the same period patient was treated with ETOPOSIDE (100 Mg/m2, Qdx5, Intravenous) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (400 Mg/m2, Qdx5, Intravenous) (View Cyclophosphamide Review and Cyclophosphamide Label ), CLOXACILLIN BENZATHINE (View Cloxacillin Benzathine Review and Cloxacillin Benzathine Label ), ZOFRAN (View Zofran Review and Zofran Label ).

6588791-5 | Thrombocytopenia
on Feb 08, 2010 Male patient from UNITED STATES , weighting 199.0 lb, was diagnosed with myelodysplastic syndrome, infection prophylaxis, hypothyroidism, hypertension, hyperlipidaemia, gastrooesophageal reflux disease, insomnia and was treated with Clolar (View Usage). Patient had the following side effects: thrombocytopenia. Clolar dosage: 9 Mg, Qdx5. During the same period patient was treated with LEVAQUIN (500 Mg, Qd) (View Levaquin Review and Levaquin Label ), SYNTHROID (125 Mcg, Qd) (View Synthroid Review and Synthroid Label ), TOPROL XL (50 Mg, Qd) (View Toprol-xl Review and Toprol-xl Label ), VYTORIN (1 Unk, Qd, 10/20) (View Vytorin Review and Vytorin Label ), PROTONIX (40 Mg, Qd) (View Protonix Review and Protonix Label ), DIOVAN (View Diovan Review and Diovan Label ), AMBIEN (10 Mg, Qd) (View Ambien Review and Ambien Label ).

6574334-9 | Apnoea, Blood Culture Positive, Bradycardia, Cardio-respiratory Arrest, Febrile Neutropenia, Hypersensitivity, Hypotension
on Jan 19, 2010 Male patient from HONG KONG , child 9 years of age, weighting 68.78 lb, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: apnoea, blood culture positive, bradycardia, cardio-respiratory arrest, febrile neutropenia, hypersensitivity, hypotension. Clolar dosage: 40 Mg, Qdx5, Intravenous. During the same period patient was treated with CYCLOPHOSPHAMIDE (470 Mg, Qd) (View Cyclophosphamide Review and Cyclophosphamide Label ), ETOPOSIDE (107 Mg, Once) (View Etoposide Review and Etoposide Label ).

6552568-7 | Ascites, Blood Bilirubin Increased, Collapse Of Lung, Continuous Haemodiafiltration, Electrocardiogram Qt Prolonged, Hepatosplenomegaly, Multi-organ Failure, Pericarditis, Peritoneal Haemorrhage
Patient was taking Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: ascites, blood bilirubin increased, collapse of lung, continuous haemodiafiltration, electrocardiogram qt prolonged, hepatosplenomegaly, multi-organ failure, pericarditis, peritoneal haemorrhage on Jan 13, 2010 from UNITED STATES Additional patient health information: Male patient , 23 years of age, weighting 213.8 lb, was diagnosed with acute myeloid leukaemia and. Clolar dosage: 40 Mg/m2, Once, Intravenous; 20 Mg/m2, Once, Intravenous. During the same period patient was treated with THIOTEPA (32 Mg, Qd, Intravenous) (View Thiotepa Review and Thiotepa Label ), VINORELBINE TARTRATE (22 Mg, Once, Intravenous) (View Vinorelbine Tartrate Review and Vinorelbine Tartrate Label ), TOPOTECAN (2.1 Mg, Qdx5, Intravenous) (View Topotecan Review and Topotecan Label ), RASBURICASE (RASBURICASE) (View Rasburicase (rasburicase) Review and Rasburicase (rasburicase) Label ), ONDANSETRON (View Ondansetron Review and Ondansetron Label ), AMIKACIN SULFATE (View Amikacin Sulfate Review and Amikacin Sulfate Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ). Patient was hospitalized.

6551614-4 | Pain, Rhabdomyosarcoma
Adverse event was reported on Jan 11, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 76 Mg, Qdx5, Intravenous) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , 18 years of age, weighting 156.5 lb, Patient had the following side effects: pain (What is pain?), rhabdomyosarcoma. During the same period patient was treated with ALLOPURINOL (View Allopurinol Review and Allopurinol Label ), HYDROCORTONE (View Hydrocortone Review and Hydrocortone Label ), ZOFRAN (View Zofran Review and Zofran Label ).

6539640-2 | Anuria, Blood Culture Positive, Haemodialysis, Renal Failure Acute, Sepsis, Staphylococcal Infection
on Dec 18, 2008 Male patient from UNITED STATES , 23 years of age, weighting 216.5 lb, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: anuria, blood culture positive, haemodialysis, renal failure acute, sepsis (What is sepsis?), staphylococcal infection (What is staphylococcal infection?). Clolar dosage: 40 Mg/m2, Once, Intravenous; 20 Mg/m2, Once, Intravenous. During the same period patient was treated with THIOTEPA (32 Mg, Qd, Intravenous) (View Thiotepa Review and Thiotepa Label ), VINORELBINE TARTRATE (42 Mg, Once, Intravenous) (View Vinorelbine Tartrate Review and Vinorelbine Tartrate Label ), TOPOTECAN (TOPOTECAN HYDROCHLORIDE) (2.1 Mg, Qdx5, Intravenous) (View Topotecan (topotecan Hydrochloride) Review and Topotecan (topotecan Hydrochloride) Label ), RASBURICASE (RASBURICASE) (View Rasburicase (rasburicase) Review and Rasburicase (rasburicase) Label ), ONDANSETRON (View Ondansetron Review and Ondansetron Label ), AMIKACIN SULFATE (View Amikacin Sulfate Review and Amikacin Sulfate Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ). Patient was hospitalized.

6539619-0 | Infusion Related Reaction, Pain, Rhabdomyosarcoma
on Jun 25, 2009 Male patient from UNITED STATES , 18 years of age, weighting 156.5 lb, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: infusion related reaction, pain (What is pain?), rhabdomyosarcoma. Clolar dosage: 76 Mg, Qdx5, Intravenous. During the same period patient was treated with ALLOPURINOL (View Allopurinol Review and Allopurinol Label ), HYDROCORTONE (View Hydrocortone Review and Hydrocortone Label ), ZOFRAN (View Zofran Review and Zofran Label ).

6537876-8 | Acute Leukaemia, Blast Cell Count Increased, Disease Progression, No Therapeutic Response
Patient was taking Clolar (View Usage). Patient had the following side effects: acute leukaemia, blast cell count increased, disease progression, no therapeutic response on Feb 18, 2009 from BRAZIL Additional patient health information: Male patient , child 6 years of age, was diagnosed with acute leukaemia and. Clolar dosage: .