CLOLAR Side Effects

7024225-4 | Acute Graft Versus Host Disease, Acute Respiratory Failure, Dialysis, Herpes Zoster Ophthalmic, Pneumonia, Pneumonia Fungal, Pneumonia Viral, Pulmonary Haemorrhage, Pulmonary Oedema
on Sep 17, 2010 Male patient from UNITED STATES , 22 years of age, weighting 169.3 lb, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: acute graft versus host disease, acute respiratory failure, dialysis (What is dialysis?), herpes zoster ophthalmic, pneumonia (What is pneumonia?), pneumonia fungal, pneumonia viral, pulmonary haemorrhage, pulmonary oedema. Clolar dosage: 21 Mg, Qd, Intravenous. During the same period patient was treated with FLUDARA (62 Mg, Qd, Intravenous) (View Fludara Review and Fludara Label ), BUSULFAN (BUSULFAN) (299 Mg, Qd, Intravenous, 373 Mg, Qd, Intravenous) (View Busulfan (busulfan) Review and Busulfan (busulfan) Label ), ACYCLOVIR (View Acyclovir Review and Acyclovir Label ), AZTREONAM (AZTREONAM) (View Aztreonam (aztreonam) Review and Aztreonam (aztreonam) Label ), CADEXZOMER IODINE (CADEXOMER IODINE) (View Cadexzomer Iodine (cadexomer Iodine) Review and Cadexzomer Iodine (cadexomer Iodine) Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), DAPTOMYCIN (View Daptomycin Review and Daptomycin Label ). Patient was hospitalized.

7018124-1 | Pancytopenia, Sepsis
Patient was taking Clolar (View Usage). Patient had the following side effects: pancytopenia, sepsis (What is sepsis?) on Sep 17, 2010 from UNITED STATES Additional patient health information: Male patient , weighting 135.0 lb, was diagnosed with myelodysplastic syndrome and. Clolar dosage: 26 Mg, Qdx4. During the same period patient was treated with FOLIC ACID (View Folic Acid Review and Folic Acid Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), PROZAC (View Prozac Review and Prozac Label ), CARDIZEM (View Cardizem Review and Cardizem Label ), TOPROL XL (View Toprol-xl Review and Toprol-xl Label ).

7017959-9 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Bacteraemia, Blood Amylase Increased, Capillary Leak Syndrome, Febrile Neutropenia, Hypocalcaemia, Hypokalaemia, Hypophosphataemia
Adverse event was reported on Sep 16, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 625 Mg, Unk) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , 15 years of age, weighting 251.3 lb, After Clolar was administered, patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, bacteraemia, blood amylase increased, capillary leak syndrome, febrile neutropenia, hypocalcaemia, hypokalaemia, hypophosphataemia. During the same period patient was treated with CYTARABINE (12000 Mg, Unk) (View Cytarabine Review and Cytarabine Label ). Patient was hospitalized.

7006039-4 | Dyspnoea, Gastrointestinal Haemorrhage, Hypotension, Pulmonary Oedema, Tumour Lysis Syndrome
on Sep 13, 2010 Male patient from CANADA , weighting 159.4 lb, was diagnosed with acute lymphocytic leukaemia, prophylaxis, septic shock, nausea (What is nausea?), oral herpes and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: dyspnoea, gastrointestinal haemorrhage, hypotension, pulmonary oedema, tumour lysis syndrome. Clolar dosage: 100 Mg, Once. 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 ).


7006006-0 | Febrile Neutropenia, Leukopenia, Pancytopenia, Sepsis
on Sep 09, 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 had the following side 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 ).

7001499-7 | Malignant Neoplasm Progression, Neutropenia
Patient was taking Clolar (View Usage). After Clolar was administered, patient had the following side effects: malignant neoplasm progression, neutropenia on Sep 09, 2010 from ARGENTINA Additional patient health information: Male patient , child 5 years of age, was diagnosed with acute lymphocytic leukaemia and. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with ETOPOSIDE (100 Mg/m2, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (100 Mg/m2, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ).

7000609-5 | Abdominal Pain, Cholecystitis, Dehydration, Diarrhoea, Hypotension, Liver Function Test Abnormal, Mucosal Inflammation, Pyrexia, Sepsis
Adverse event was reported on Sep 10, 2010 by a Female patient taking Clolar (View Usage) (Dosage: 30 Mg, Qdx5) was diagnosed with acute lymphocytic leukaemia and. Location: UNITED STATES , 44 years of age, weighting 113.8 lb, Patient experienced the following unwanted or unexpected effects: abdominal pain (What is abdominal pain?), cholecystitis, dehydration, diarrhoea, hypotension, liver function test abnormal, mucosal inflammation, pyrexia, sepsis (What is sepsis?). During the same period patient was treated with ETOPOSIDE (150 Mg, Qdx5) (View Etoposide Review and Etoposide Label ), MITOXANTRONE (12 Mg, Qdx3) (View Mitoxantrone Review and Mitoxantrone Label ). Patient was hospitalized.

6999970-7 | Amaurosis, Bone Marrow Failure, Cerebral Haematoma, Clostridium Difficile Colitis, Cytomegalovirus Infection, Graft Versus Host Disease, Hypogammaglobulinaemia, Pancytopenia, Pulmonary Mycosis
on Sep 08, 2010 Male patient from ARGENTINA , 33 years of age, was diagnosed with acute lymphocytic leukaemia, non-hodgkin's lymphoma, fungal infection (What is fungal infection?), acute graft versus host disease and was treated with Clolar (View Usage). Patient had the following side effects: amaurosis, bone marrow failure, cerebral haematoma, clostridium difficile colitis, cytomegalovirus infection (What is cytomegalovirus infection?), graft versus host disease, hypogammaglobulinaemia, pancytopenia, pulmonary mycosis. Clolar dosage: . During the same period patient was treated with ETOPOSIDE (Unk) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), AMPHOTERICIN B (Unk) (View Amphotericin B Review and Amphotericin B Label ), FK 506 (View Fk 506 Review and Fk 506 Label ), CORTICOSTEROIDS FOR SYSTEMIC USE (View Corticosteroids For Systemic Use Review and Corticosteroids For Systemic Use Label ). Patient was hospitalized.

6992654-0 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Capillary Leak Syndrome, Febrile Neutropenia, Hypocalcaemia, Hypokalaemia, Hypophosphataemia
on Sep 09, 2010 Male patient from UNITED STATES , 15 years of age, weighting 251.3 lb, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, capillary leak syndrome, febrile neutropenia, hypocalcaemia, hypokalaemia, hypophosphataemia. Clolar dosage: 625 Mg, Unk. During the same period patient was treated with CYTARABINE (12000 Mg, Unk) (View Cytarabine Review and Cytarabine Label ). Patient was hospitalized.

6992056-7 | Aplasia, Sepsis
Patient was taking Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: aplasia, sepsis (What is sepsis?) on Sep 07, 2010 from ARGENTINA Additional patient health information: Male patient , child 9 years of age, was diagnosed with acute lymphocytic leukaemia and. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with ETOPOSIDE (100 Mg/m2, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (100 Mg/m2, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ).

6987192-5 |
Adverse event was reported on Sep 07, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 40 Mg/m2, Qdx5) was diagnosed with acute lymphocytic leukaemia and. Location: ARGENTINA , 18 years of age, . During the same period patient was treated with ETOPOSIDE (100 Mg/m2, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (100 Mg/m2, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ).

6985267-8 | Acute Lymphocytic Leukaemia
on Sep 07, 2010 Female patient from ARGENTINA , 41 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: acute lymphocytic leukaemia. Clolar dosage: Unk. During the same period patient was treated with CYTARABINE (View Cytarabine Review and Cytarabine Label ).

6985057-6 | Acute Lymphocytic Leukaemia, Malignant Neoplasm Progression
on Sep 07, 2010 Female patient from ARGENTINA , child 9 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: acute lymphocytic leukaemia, malignant neoplasm progression. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with CYTARABINE (View Cytarabine Review and Cytarabine Label ).

6984443-8 | Acute Megakaryocytic Leukaemia
Patient was taking Clolar (View Usage). Patient had the following side effects: acute megakaryocytic leukaemia on Sep 06, 2010 from ARGENTINA Additional patient health information: Male patient , child 1 years of age, was diagnosed with acute megakaryocytic leukaemia and. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with ETOPOSIDE (100 Mg/m2, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (100 Mg/m2, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ).

6984421-9 | Acute Lymphocytic Leukaemia
Adverse event was reported on Sep 07, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 40 Mg/m2, Qdx5) was diagnosed with acute lymphocytic leukaemia and. Location: ARGENTINA , child 8 years of age, After Clolar was administered, patient had the following side effects: acute lymphocytic leukaemia. During the same period patient was treated with ETOPOSIDE (100 Mg/m2, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (100 Mg/m2, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ).

6980432-8 | Haemorrhage Intracranial, Pancytopenia
on Aug 23, 2010 Male patient from UNITED STATES , weighting 199.0 lb, was diagnosed with myelodysplastic syndrome, prophylaxis, infection prophylaxis, hypothyroidism, hypertension, hyperlipidaemia, gastrooesophageal reflux disease, insomnia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: haemorrhage intracranial, pancytopenia. Clolar dosage: 9 Mg, Qdx5. During the same period patient was treated with NEULASTA (6 Mg, Once) (View Neulasta Review and Neulasta Label ), 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 Tab Qd) (View Vytorin Review and Vytorin Label ), PROTONIX (40 Mg, Qd) (View Protonix Review and Protonix Label ), AMBIEN (10 Mg, Prn) (View Ambien Review and Ambien Label ).

6974033-5 | Acute Graft Versus Host Disease
on Sep 07, 2010 Male patient from ARGENTINA , 19 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). Patient had the following side effects: acute graft versus host disease. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with ETOPOSIDE (100 Mg/m2, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (100 Mg/m2, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ).

6974030-X | Disease Progression
Patient was taking Clolar (View Usage). After Clolar was administered, patient had the following side effects: disease progression on Sep 06, 2010 from ARGENTINA Additional patient health information: Female patient , 15 years of age, was diagnosed with acute lymphocytic leukaemia and. Clolar dosage: 40 Mg/m2, Qd. During the same period patient was treated with ETOPOSIDE (100 Mcg/m2, Qd) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (100 Mg/m2, Qd) (View Cyclophosphamide Review and Cyclophosphamide Label ).

6974029-3 | Aplasia, Sepsis
Adverse event was reported on Sep 06, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 52 Mg/m2, Qdx5) was diagnosed with acute lymphocytic leukaemia and. Location: ARGENTINA , 17 years of age, Patient experienced the following unwanted or unexpected effects: aplasia, sepsis (What is sepsis?).

6974027-X | Disease Progression
on Sep 06, 2010 Female patient from ARGENTINA , child 12 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). Patient had the following side effects: disease progression. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with ETOPOSIDE (100 Mg/m2, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (100 Mg/m2, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ).

6972759-0 | Febrile Neutropenia, Respiratory Distress, Staphylococcal Bacteraemia
on Sep 03, 2010 Female patient from UNITED STATES , weighting 119.5 lb, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: febrile neutropenia, respiratory distress, staphylococcal bacteraemia. Clolar dosage: 47 Mg, Unk.

6972739-5 | Cardio-respiratory Arrest, Hepatic Failure, Hypotension, Neutropenic Colitis, Oliguria, Tachycardia
Patient was taking Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: cardio-respiratory arrest, hepatic failure, hypotension, neutropenic colitis, oliguria, tachycardia on Aug 26, 2010 from MEXICO Additional patient health information: Female patient , weighting 363.8 lb, was diagnosed with acute leukaemia, prophylaxis, febrile neutropenia, gastritis, pain in extremity, pyrexia, constipation (What is constipation?), neutropenic colitis and. Clolar dosage: Unk. During the same period patient was treated with FLUCONAZOLE (100 Mg, Qd) (View Fluconazole Review and Fluconazole Label ), CEFEPIME (2 G, Qdx3) (View Cefepime Review and Cefepime Label ), OMEPRAZOLE (20 Mg, Qd) (View Omeprazole Review and Omeprazole Label ), LYSINE (1 Unk, Unk) (View Lysine Review and Lysine Label ), ACETAMINOPHEN (1 G, Unk) (View Acetaminophen Review and Acetaminophen Label ), SENNOSIDE (2 Other, Unk) (View Sennoside Review and Sennoside Label ), HYDROCORTISONE (200 Mg, Qdx3) (View Hydrocortisone Review and Hydrocortisone Label ), METRONIDAZOLE (500 Mg, Qdx3) (View Metronidazole Review and Metronidazole Label ).

6972695-X | Epistaxis, Haematemesis, Pulmonary Haemorrhage, Thrombocytopenia
Adverse event was reported on Aug 27, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 40 Mg/m2, Qdx5) was diagnosed with acute lymphocytic leukaemia, bone marrow failure, prophylaxis and. Location: MEXICO , weighting 153.2 lb, Patient had the following side effects: epistaxis, haematemesis, pulmonary haemorrhage, thrombocytopenia. During the same period patient was treated with ETOPOSIDE (175 Mg, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (700 Mg, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ), NEUPOGEN (300 Mcg, Unk) (View Neupogen Review and Neupogen Label ), DEXAMETHASONE (3.5 Mg, Tid) (View Dexamethasone Review and Dexamethasone Label ).

6971596-0 | Cardiac Failure Congestive, Cellulitis, Local Swelling, Mouth Haemorrhage, Swelling Face
on Sep 02, 2010 Female patient from UNITED STATES , weighting 147.7 lb, was diagnosed with acute myeloid leukaemia and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: cardiac failure congestive, cellulitis (What is cellulitis?), local swelling, mouth haemorrhage, swelling face. Clolar dosage: 34 Mg, Qdx5. During the same period patient was treated with ETOPOSIDE (Unk Unk, Qdx5) (View Etoposide Review and Etoposide Label ), MITOXANTRONE (Unk Unk, Qd) (View Mitoxantrone Review and Mitoxantrone Label ). Patient was hospitalized.

6970292-3 | Bronchial Wall Thickening, Bronchitis, Cardiomegaly, Dehydration, Nausea, Neutropenia, Neutropenic Infection, Pancytopenia, Pulmonary Congestion
on Aug 24, 2010 Female patient from UNITED STATES , 73 years of age, weighting 172.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: bronchial wall thickening, bronchitis (What is bronchitis?), cardiomegaly, dehydration, nausea (What is nausea?), neutropenia, neutropenic infection, pancytopenia, pulmonary congestion. Clolar dosage: 19 Mg, Qdx5, Intravenous. During the same period patient was treated with ATENOLOL (View Atenolol Review and Atenolol Label ), CARISOPRODOL (View Carisoprodol Review and Carisoprodol Label ), DIOVAN (View Diovan Review and Diovan Label ), LEXAPRO (View Lexapro Review and Lexapro Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), NIFEDIPINE (View Nifedipine Review and Nifedipine Label ), PREMPRO (ESTROGENS CONJUFATED, MEDROXPROGESTERONE ACETATE) (View Prempro (estrogens Conjufated, Medroxprogesterone Acetate) Review and Prempro (estrogens Conjufated, Medroxprogesterone Acetate) Label ), PRILOSEC (OMEPRAZOLE) (View Prilosec (omeprazole) Review and Prilosec (omeprazole) Label ). Patient was hospitalized.

6970066-3 | Depressed Level Of Consciousness
Patient was taking Clolar (View Usage). Patient had the following side effects: depressed level of consciousness on Sep 03, 2010 from UNITED STATES Additional patient health information: Male patient , weighting 54.01 lb, was diagnosed with acute lymphocytic leukaemia, prophylaxis against graft versus host disease, adenovirus infection, infection prophylaxis, rectal fissure and. Clolar dosage: 52 Mg/m2, Qdx5. During the same period patient was treated with CYTARABINE (1000 Mg/m2, Qd) (View Cytarabine Review and Cytarabine Label ), TACROLIMUS (0.027 Mg/kg, Unk) (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (810 Mg, Qid) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), CIDOFOVIR (25 Mg, Unk) (View Cidofovir Review and Cidofovir Label ), HYDROCORTISONE (1 Unk, Q12hr) (View Hydrocortisone Review and Hydrocortisone Label ), IMMUNE GLOBULIN NOS (4900 Mg, Q3w) (View Immune Globulin Nos Review and Immune Globulin Nos Label ), TRIAMCINOLONE (0.1 Unk, Q12hr) (View Triamcinolone Review and Triamcinolone Label ), ZINC OXIDE (20 Unk, Q4hr) (View Zinc Oxide Review and Zinc Oxide Label ).

6970054-7 | Disease Progression
Adverse event was reported on Aug 30, 2010 by a Female patient taking Clolar (View Usage) (Dosage: 10 Mg, Unk) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , 81 years of age, After Clolar was administered, patient had the following side effects: disease progression. During the same period patient was treated with CYTARABINE (Unk) (View Cytarabine Review and Cytarabine Label ).

6966187-1 | Blood Potassium Decreased, Blood Pressure Increased, Confusional State, Dyspnoea, Epistaxis, Gastrointestinal Haemorrhage, Haemorrhage Intracranial, Pancytopenia, Restlessness
on Aug 23, 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: blood potassium decreased, blood pressure increased, confusional state, dyspnoea, epistaxis, gastrointestinal haemorrhage, haemorrhage intracranial, pancytopenia, restlessness. 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 ).

6966155-X | Haemorrhage Intracranial, Pancytopenia
on Aug 23, 2010 Male patient from UNITED STATES , weighting 199.0 lb, was diagnosed with myelodysplastic syndrome, prophylaxis, infection prophylaxis, hypothyroidism, hypertension, hyperlipidaemia, gastrooesophageal reflux disease, insomnia and was treated with Clolar (View Usage). Patient had the following side effects: haemorrhage intracranial, pancytopenia. Clolar dosage: 9 Mg, Qdx5. During the same period patient was treated with NEULASTA (6 Mg, Once) (View Neulasta Review and Neulasta Label ), 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 Tab Qd) (View Vytorin Review and Vytorin Label ), PROTONIX (40 Mg, Qd) (View Protonix Review and Protonix Label ), AMBIEN (10 Mg, Prn) (View Ambien Review and Ambien Label ).

6964865-1 | Aplasia, Infection, Pneumonia, Varicella
Patient was taking Clolar (View Usage). After Clolar was administered, patient had the following side effects: aplasia, infection (What is infection?), pneumonia (What is pneumonia?), varicella on Aug 24, 2010 from MEXICO Additional patient health information: Female patient , weighting 40.79 lb, was diagnosed with acute lymphocytic leukaemia and. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with ETOPOSIDE (74 Mg, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (300 Mg, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ), NEUPOGEN (60 Mcg, Qd) (View Neupogen Review and Neupogen Label ), PREDNISONE (Unk) (View Prednisone Review and Prednisone Label ), MESNA (Unk) (View Mesna Review and Mesna Label ).

6955764-X | Cellulitis, Local Swelling, Mouth Haemorrhage, Swelling Face
Adverse event was reported on Aug 18, 2010 by a Female patient taking Clolar (View Usage) (Dosage: 34 Mg, Qdx5) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , weighting 147.7 lb, Patient experienced the following unwanted or unexpected effects: cellulitis (What is cellulitis?), local swelling, mouth haemorrhage, swelling face. During the same period patient was treated with ETOPOSIDE (Unk Unk, Qdx5) (View Etoposide Review and Etoposide Label ), MITOXANTRONE (Unk Unk, Qd) (View Mitoxantrone Review and Mitoxantrone Label ). Patient was hospitalized.

6955654-2 | Epistaxis, Haematemesis, Pulmonary Haemorrhage, Thrombocytopenia
on Aug 17, 2010 Male patient from MEXICO , weighting 153.2 lb, was diagnosed with acute lymphocytic leukaemia, bone marrow failure, prophylaxis and was treated with Clolar (View Usage). Patient had the following side effects: epistaxis, haematemesis, pulmonary haemorrhage, thrombocytopenia. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with ETOPOSIDE (175 Mg, Qdx5) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (700 Mg, Qdx5) (View Cyclophosphamide Review and Cyclophosphamide Label ), NEUPOGEN (300 Mcg, Unk) (View Neupogen Review and Neupogen Label ), DEXAMETHASONE (3.5 Mg, Tid) (View Dexamethasone Review and Dexamethasone Label ).

6943333-7 | Aplasia, Infection, Pneumonia, Varicella
on Aug 17, 2010 Female patient from MEXICO , child 7 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: aplasia, infection (What is infection?), pneumonia (What is pneumonia?), varicella. Clolar dosage: 40 Mg/m2, Qdx5. During the same period patient was treated with ETOPOSIDE (Unk) (View Etoposide Review and Etoposide Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), NEUPOGEN (Unk) (View Neupogen Review and Neupogen Label ), PREDNISONE (Unk) (View Prednisone Review and Prednisone Label ), MESNA (Unk) (View Mesna Review and Mesna Label ).

6938440-9 | 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 Aug 12, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 20.50 lb, was diagnosed with acute myeloid leukaemia, antiviral prophylaxis, antifungal prophylaxis and. Clolar dosage: 19.8 Mg, Qdx5. During the same period patient was treated with 03 OKT (19.78 Mg, Qd Tapered Up Then Down) (View 03-okt Review and 03-okt Label ), THIOTEPA (43.5 Mg, Bid) (View Thiotepa Review and Thiotepa Label ), MELPHALAN (26.4 Mg, Qd) (View Melphalan Review and Melphalan Label ), RITUXIMAB (16.5 Mg, Qd) (View Rituximab Review and Rituximab Label ), 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 ).

6936726-5 | Acute Graft Versus Host Disease In Skin, Enterococcal Bacteraemia, Pyrexia, Staphylococcal Bacteraemia
Adverse event was reported on Aug 13, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 27 Mg, Qdx5) was diagnosed with acute lymphocytic leukaemia, antiviral prophylaxis, prophylaxis against graft versus host disease, antifungal prophylaxis and. Location: UNITED STATES , weighting 31.75 lb, Patient had the following side effects: acute graft versus host disease in skin, enterococcal bacteraemia, pyrexia, staphylococcal bacteraemia. During the same period patient was treated with ACYCLOVIR (295 Mg, Unk) (View Acyclovir Review and Acyclovir Label ), IMMUNE GLOBULIN NOS (5 G, Unk) (View Immune Globulin Nos Review and Immune Globulin Nos Label ), FLAGYL (90 Mg, Unk) (View Flagyl Review and Flagyl Label ), CELLCEPT (100 Mg, Unk) (View Cellcept Review and Cellcept Label ), NYSTATIN (500000 U, Unk) (View Nystatin Review and Nystatin Label ). Patient was hospitalized.

6931502-1 | Blood Sodium Decreased, Bronchitis, Cardiomegaly, Dehydration, Fatigue, Fluid Retention, Nausea, Neutropenic Infection, Pancytopenia
on Jul 30, 2010 Female patient from UNITED STATES , 73 years of age, weighting 172.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: blood sodium decreased, bronchitis (What is bronchitis?), cardiomegaly, dehydration, fatigue, fluid retention, nausea (What is nausea?), neutropenic infection, pancytopenia. Clolar dosage: 19 Mg, Qdx5, Intravenous. During the same period patient was treated with ATENOLOL (View Atenolol Review and Atenolol Label ), CARISOPRODOL (View Carisoprodol Review and Carisoprodol Label ), DIOVAN (View Diovan Review and Diovan Label ), LEXAPRO (View Lexapro Review and Lexapro Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), NIFEDIPINE (View Nifedipine Review and Nifedipine Label ), PREMPRO (View Prempro Review and Prempro Label ), PRILOSEC (OMEPRAZOLE) (View Prilosec (omeprazole) Review and Prilosec (omeprazole) Label ). Patient was hospitalized.

6930622-5 | Haemorrhage Intracranial, Pancytopenia
on Aug 11, 2010 Male patient from UNITED STATES , weighting 199.0 lb, was diagnosed with myelodysplastic syndrome, prophylaxis, infection prophylaxis, hypothyroidism, hypertension, hyperlipidaemia, gastrooesophageal reflux disease, insomnia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: haemorrhage intracranial, pancytopenia. Clolar dosage: 9 Mg, Qdx5. During the same period patient was treated with NEULASTA (6 Mg, Once) (View Neulasta Review and Neulasta Label ), 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 Tab Qd) (View Vytorin Review and Vytorin Label ), PROTONIX (40 Mg, Qd) (View Protonix Review and Protonix Label ), AMBIEN (10 Mg, Prn) (View Ambien Review and Ambien Label ).

6930286-0 | Agitation, Aplasia, Cerebral Artery Occlusion, Cerebrovascular Accident, Insomnia, Leukopenia, Palmar-plantar Erythrodysaesthesia Syndrome, Pancytopenia
Patient was taking Clolar (View Usage). Patient had the following side effects: agitation, aplasia, cerebral artery occlusion, cerebrovascular accident, insomnia, leukopenia, palmar-plantar erythrodysaesthesia syndrome, pancytopenia on Aug 05, 2010 from UNITED STATES Additional patient health information: Female patient , child 9 years of age, was diagnosed with acute lymphocytic leukaemia and. Clolar dosage: Unk Unk, Unk. During the same period patient was treated with DIPHENHYDRAMINE (View Diphenhydramine Review and Diphenhydramine Label ).

6928115-4 | Acute Graft Versus Host Disease In Skin, Atrial Fibrillation, Bk Virus Infection, Blood Bilirubin Increased, Diarrhoea, Enterococcal Bacteraemia, Ileus, Pneumonia, Pulmonary Oedema
Adverse event was reported on Aug 05, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 30 Mg/ml, Qd) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , weighting 302.7 lb, After Clolar was administered, patient had the following side effects: acute graft versus host disease in skin, atrial fibrillation (What is atrial fibrillation?), bk virus infection, blood bilirubin increased, diarrhoea, enterococcal bacteraemia, ileus, pneumonia (What is pneumonia?), pulmonary oedema. During the same period patient was treated with BUSULFAN (0.8 Mg/kg, Qid(q6hr)) (View Busulfan Review and Busulfan Label ), INSULIN GLARGINE (18 U, Qd) (View Insulin Glargine Review and Insulin Glargine Label ), LEVOFLOXACIN (250 Mg, Qod) (View Levofloxacin Review and Levofloxacin Label ), METHYLPREDNISOLONE (5 Mg, Qd) (View Methylprednisolone Review and Methylprednisolone Label ), DILTIAZEM (8 Mg, Q1hr) (View Diltiazem Review and Diltiazem Label ), HEPARIN (1.9 Mg, 3x/w) (View Heparin Review and Heparin Label ), FENTANYL (25 Mcg, Q1hr) (View Fentanyl Review and Fentanyl Label ). Patient was hospitalized.

6921726-1 | Malaise, Respiratory Disorder
on Aug 02, 2010 Male patient from UNITED STATES , 18 years of age, weighting 257.9 lb, was diagnosed with acute lymphocytic leukaemia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: malaise, respiratory disorder. Clolar dosage: Unk Unk, Unk.

6920094-9 | Dyspnoea, Gastrointestinal Haemorrhage, Hypotension, Pulmonary Oedema, Tumour Lysis Syndrome
on Jul 20, 2010 Male patient from CANADA , weighting 159.4 lb, was diagnosed with acute lymphocytic leukaemia, prophylaxis, septic shock, nausea (What is nausea?), oral herpes and was treated with Clolar (View Usage). Patient had the following side effects: dyspnoea, gastrointestinal haemorrhage, hypotension, pulmonary oedema, tumour lysis syndrome. Clolar dosage: 100 Mg, Once. 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 ).

6915069-X | Carotid Artery Occlusion, Cerebral Infarction, Decerebration, Hypotension, Mydriasis, Periorbital Oedema, Streptococcal Bacteraemia
Patient was taking Clolar (View Usage). After Clolar was administered, patient had the following side effects: carotid artery occlusion, cerebral infarction, decerebration, hypotension, mydriasis, periorbital oedema, streptococcal bacteraemia on May 26, 2010 from UNITED STATES Additional patient health information: Male patient , child 3 years of age, was diagnosed with acute leukaemia, acute myeloid leukaemia and. Clolar dosage: . During the same period patient was treated with FLUDARABINE (View Fludarabine Review and Fludarabine Label ), GRANULOCYTE COLONY STIMULATING FACTOR (View Granulocyte Colony Stimulating Factor Review and Granulocyte Colony Stimulating Factor Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ).

6914772-5 | Depressed Level Of Consciousness
Adverse event was reported on Jul 30, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 52 Mg/m2, Qdx5) was diagnosed with acute lymphocytic leukaemia, prophylaxis against graft versus host disease, adenovirus infection, infection prophylaxis, rectal fissure and. Location: UNITED STATES , weighting 54.01 lb, Patient experienced the following unwanted or unexpected effects: depressed level of consciousness. During the same period patient was treated with CYTARABINE (1000 Mg/m2, Qd) (View Cytarabine Review and Cytarabine Label ), TACROLIMUS (0.027 Mg/kg, Unk) (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (810 Mg, Qid) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), CIDOFOVIR (25 Mg, Unk) (View Cidofovir Review and Cidofovir Label ), HYDROCORTISONE (1 %, Q12hr) (View Hydrocortisone Review and Hydrocortisone Label ), IMMUNE GLOBULIN NOS (4900 Mg, Q3w) (View Immune Globulin Nos Review and Immune Globulin Nos Label ), TRIAMCINOLONE (0.1 %, Q12hr) (View Triamcinolone Review and Triamcinolone Label ), ZINC OXIDE (20 %, Q4hr) (View Zinc Oxide Review and Zinc Oxide Label ).

6905950-X | Dyspnoea, Gastrointestinal Haemorrhage, Hypotension, Pulmonary Oedema, Tumour Lysis Syndrome
on Jul 20, 2010 Male patient from CANADA , weighting 159.4 lb, was diagnosed with acute lymphocytic leukaemia, prophylaxis, septic shock, nausea (What is nausea?), oral herpes and was treated with Clolar (View Usage). Patient had the following side effects: dyspnoea, gastrointestinal haemorrhage, hypotension, pulmonary oedema, tumour lysis syndrome. Clolar dosage: 100 Mg, Once. 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 ).

6901104-1 | Dyspnoea, Gastrointestinal Haemorrhage, Hypotension, Pulmonary Oedema, Tumour Lysis Syndrome
on Jul 20, 2010 Male patient from CANADA , weighting 159.4 lb, was diagnosed with acute lymphocytic leukaemia, prophylaxis, septic shock, nausea (What is nausea?), oral herpes and was treated with Clolar (View Usage). After Clolar was administered, patient had the following side effects: dyspnoea, gastrointestinal haemorrhage, hypotension, pulmonary oedema, tumour lysis syndrome. Clolar dosage: 100 Mg, Once. 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 ).

6888360-3 | Acute Myeloid Leukaemia
Patient was taking Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: acute myeloid leukaemia on Jul 21, 2010 from BRAZIL Additional patient health information: Male patient , child 2 years of age, was diagnosed with acute myeloid leukaemia and. Clolar dosage: Unk.

6860322-1 | Arthralgia, Chills, Infusion Related Reaction, Muscle Spasms
Adverse event was reported on Jul 19, 2010 by a Male patient taking Clolar (View Usage) (Dosage: 28-44 Mg 3-day Cycles Iv Drip) was diagnosed with acute myeloid leukaemia recurrent and. Location: UNITED STATES , weighting 104.5 lb, Patient had the following side effects: arthralgia, chills, infusion related reaction, muscle spasms. Patient was hospitalized.

6849268-2 | Cardiomegaly, Lung Infiltration, Neutropenia, Pain, Pneumonia, Pulmonary Oedema, Respiratory Disorder
on Jul 02, 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.

6819854-4 | Encephalopathy, Febrile Neutropenia, Hypokalaemia, Hypotension, Mental Status Changes, Pancytopenia, Respiratory Distress, Septic Shock
on Jun 23, 2010 Female patient from UNITED STATES , weighting 185.4 lb, was diagnosed with acute myeloid leukaemia, febrile neutropenia and was treated with Clolar (View Usage). Patient experienced the following unwanted or unexpected effects: encephalopathy, febrile neutropenia, hypokalaemia, hypotension, mental status changes, pancytopenia, respiratory distress, septic shock. Clolar dosage: 60 Mg, Qdx5. During the same period patient was treated with FLUDARABINE (Unk Unk, Unk) (View Fludarabine Review and Fludarabine Label ), ACYCLOVIR (Unk) (View Acyclovir Review and Acyclovir Label ), VFEND (Unk) (View Vfend Review and Vfend Label ), DECADRON (Unk) (View Decadron Review and Decadron Label ), TACROLIMUS (Unk) (View Tacrolimus Review and Tacrolimus Label ), IMIPENEM (View Imipenem Review and Imipenem Label ). Patient was hospitalized.

6815215-2 | Depressed Level Of Consciousness
Patient was taking Clolar (View Usage). Patient had the following side effects: depressed level of consciousness on Jun 23, 2010 from UNITED STATES Additional patient health information: Male patient , weighting 54.01 lb, was diagnosed with acute lymphocytic leukaemia, prophylaxis against graft versus host disease, adenovirus infection, infection prophylaxis, rectal fissure and. Clolar dosage: 52 Mg/m2, Qdx5. During the same period patient was treated with CYTARABINE (1000 Mg/m2, Qd) (View Cytarabine Review and Cytarabine Label ), TACROLIMUS (0.027 Mg/kg, Unk) (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (810 Mg, Qid) (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ), CIDOFOVIR (25 Mg, Unk) (View Cidofovir Review and Cidofovir Label ), HYDROCORTISONE (1 %, Q12hr) (View Hydrocortisone Review and Hydrocortisone Label ), IMMUNE GLOBULIN NOS (4900 Mg, Q3w) (View Immune Globulin Nos Review and Immune Globulin Nos Label ), TRIAMCINOLONE (0.1 %, Q12hr) (View Triamcinolone Review and Triamcinolone Label ), ZINC OXIDE (20 %, Q4hr) (View Zinc Oxide Review and Zinc Oxide Label ).