The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
120898463 12089846 3 F 20160909 20160218 20160915 EXP NO-SZ09-PHHY2014NO070895 NO-FRESENIUS KABI-FK201600783 FRESENIUS KABI 65.00 YR F Y 0.00000 20160915 OT NO NO

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
120898463 12089846 1 PS CYTARABINE (Manufacturer Unknown) CYTARABINE 1 Intravenous (not otherwise specified) U UNKNOWN 76512 200 MG/M**2 UNKNOWN
120898463 12089846 2 SS CYTARABINE (Manufacturer Unknown) CYTARABINE 1 Intrathecal U UNKNOWN 76512 40 MG UNKNOWN
120898463 12089846 3 SS ASPARAGINASE ASPARAGINASE 1 Intravenous (not otherwise specified) 0 10000 IU UNKNOWN
120898463 12089846 4 SS ASPARAGINASE ASPARAGINASE 1 Intravenous (not otherwise specified) 0 10 IU UNKNOWN
120898463 12089846 5 SS METHOTREXATE. METHOTREXATE 1 Intrathecal 0 1500 MG/M**2 SOLUTION FOR INJECTION
120898463 12089846 6 SS METHOTREXATE. METHOTREXATE 1 Intratracheal 0 15 MG SOLUTION FOR INJECTION
120898463 12089846 7 SS PREDNISONE. PREDNISONE 1 Intrathecal 0 10 MG UNKNOWN
120898463 12089846 8 SS PREDNISONE. PREDNISONE 1 Oral 0 40 MG/M**2 UNKNOWN
120898463 12089846 9 SS VINCRISTINE VINCRISTINE 1 Intravenous (not otherwise specified) 0 1.5 MG/M**2 UNKNOWN
120898463 12089846 10 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Intravenous (not otherwise specified) 0 750 MG/M**2
120898463 12089846 11 SS DAUNORUBICIN DAUNORUBICIN 1 Intravenous (not otherwise specified) 0 50 MG/M**2 UNKNOWN
120898463 12089846 12 SS DOXORUBICIN DOXORUBICIN 1 Intravenous (not otherwise specified) 0 30 MG/M**2 UNKNOWN
120898463 12089846 13 SS MERCAPTOPURINE. MERCAPTOPURINE 1 Oral 0 35 MG/M**2
120898463 12089846 14 SS THIOGUANINE THIOGUANINE 1 Intravenous (not otherwise specified) 0 150 MG/M**2 UNKNOWN
120898463 12089846 15 SS G-CSF GRANULOCYTE COLONY-STIMULATING FACTOR NOS 1 Unknown 0 10 UG/KG UNKNOWN
120898463 12089846 16 SS L-ASPARAGINASE ASPARAGINASE 1 Intravenous (not otherwise specified) 0 10 IU

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
120898463 12089846 1 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 3 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 5 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 7 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 9 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 10 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 11 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 12 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 13 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 14 Precursor T-lymphoblastic lymphoma/leukaemia
120898463 12089846 15 Peripheral blood stem cell apheresis
120898463 12089846 16 Precursor T-lymphoblastic lymphoma/leukaemia

Outcome of event

Event ID CASEID OUTC COD
120898463 12089846 OT
120898463 12089846 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
120898463 12089846 Febrile neutropenia
120898463 12089846 Haematotoxicity
120898463 12089846 Intracranial venous sinus thrombosis

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found