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
127840301 12784030 1 I 20160920 20160927 20160927 EXP CN-SA-2016SA178315 AVENTIS WANG J, WANG Y, WU L, ZHANG J, LAI W AND WANG Z. PEG-ASPARGASE AND DEP REGIMEN COMBINATION THERAPY FOR REFRACTORY EPSTEIN-BARR VIRUS-ASSOCIATED HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS. JOURNAL OF HEMATOLOGY + ONCOLOGY. (2016) 9:84. DOI 10.1186/S13045-016-0317-7. 0.00 A Y 0.00000 20160927 OT CN CN

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
127840301 12784030 1 PS ANTI-THYMOCYTE GLOBULIN (RABBIT) LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN 1 Unknown DOSE: U UNKNOWN 103869 3 MG/KG
127840301 12784030 2 SS METHOTREXATE. METHOTREXATE 1 Unknown U UNKNOWN 0 15 MG/M**2 QD
127840301 12784030 3 SS METHOTREXATE. METHOTREXATE 1 Unknown U UNKNOWN 0 10 MG/M**2 QD
127840301 12784030 4 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Unknown 15 MG/KG/DAY FOR DAYS 1 TO 3, 0.75 MG/KG/DAY FOR DAYS 4 TO 7, AND 0.25 MG/KG/DAY FOR DAYS 8 TO 10 U UNKNOWN 0 QD
127840301 12784030 5 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Unknown 15 MG/KG/DAY FOR DAYS 1 TO 3, 0.75 MG/KG/DAY FOR DAYS 4 TO 7, AND 0.25 MG/KG/DAY FOR DAYS 8 TO 10 U UNKNOWN 0 QD
127840301 12784030 6 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Unknown DOSE:1.8 GRAM(S)/SQUARE METER U UNKNOWN 0 QD
127840301 12784030 7 SS PEGASPARGASE PEGASPARGASE 1 Unknown DOSE: 2000 U/M2 U UNKNOWN 0
127840301 12784030 8 SS PEGASPARGASE PEGASPARGASE 1 Unknown DOSE: 2000 U/M2 U UNKNOWN 0
127840301 12784030 9 SS ETOPOSIDE. ETOPOSIDE 1 Unknown U UNKNOWN 0 100 MG/M**2 /wk
127840301 12784030 10 SS ETOPOSIDE. ETOPOSIDE 1 Unknown U UNKNOWN 0 100 MG/M**2 /wk
127840301 12784030 11 SS ETOPOSIDE. ETOPOSIDE 1 Unknown U UNKNOWN 0 100 MG/M**2 /wk
127840301 12784030 12 SS ETOPOSIDE. ETOPOSIDE 1 Unknown U UNKNOWN 0 5 MG/KG QD
127840301 12784030 13 SS ETOPOSIDE. ETOPOSIDE 1 Unknown U UNKNOWN 0 5 MG/KG QD
127840301 12784030 14 SS ETOPOSIDE. ETOPOSIDE 1 Unknown U UNKNOWN 0 5 MG/KG QD
127840301 12784030 15 SS CYCLOSPORIN A CYCLOSPORINE 1 Intravenous (not otherwise specified) U UNKNOWN 0 3 MG/KG QD
127840301 12784030 16 SS DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) U UNKNOWN 0 25 MG/M**2 INJECTION QD
127840301 12784030 17 SS DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) U UNKNOWN 0 25 MG/M**2 INJECTION QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127840301 12784030 1 Prophylaxis against graft versus host disease
127840301 12784030 2 Prophylaxis against graft versus host disease
127840301 12784030 3 Prophylaxis against graft versus host disease
127840301 12784030 4 Epstein-Barr virus infection
127840301 12784030 5 Histiocytosis haematophagic
127840301 12784030 6 Stem cell transplant
127840301 12784030 7 Epstein-Barr virus infection
127840301 12784030 8 Histiocytosis haematophagic
127840301 12784030 9 Epstein-Barr virus infection
127840301 12784030 10 Histiocytosis haematophagic
127840301 12784030 11 Stem cell transplant
127840301 12784030 12 Epstein-Barr virus infection
127840301 12784030 13 Histiocytosis haematophagic
127840301 12784030 14 Stem cell transplant
127840301 12784030 15 Prophylaxis against graft versus host disease
127840301 12784030 16 Epstein-Barr virus infection
127840301 12784030 17 Histiocytosis haematophagic

Outcome of event

Event ID CASEID OUTC COD
127840301 12784030 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127840301 12784030 Graft versus host disease

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

no results found

Therapies reported

no results found