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
126421141 12642114 1 I 20160721 20160810 20160810 EXP US-JNJFOC-20160807046 JANSSEN RYTTING ME, JABBOUR E, JORGENSEN J, RAVANDI F, FRANKLIN A, KADIA T. FINAL RESULTS OF A SINGLE INSTITUTION EXPERIENCE WITH A PEDIATRIC-BASED REGIMEN, THE AUGMENTED BERLINFRANKFURTM?NSTER, IN ADOLESCENTS AND YOUNG ADULTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA, AND COMPARISON TO THE HYPER-CVAD REGIMEN. AMERICAN JOURNAL OF HEMATOLOGY 2016;91 (8):819-823. 0.00 Y 0.00000 20160810 MD US US

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
126421141 12642114 1 PS DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE 1 Unknown N 50718 LIPOSOME INJECTION
126421141 12642114 2 SS VINCRISTINE VINCRISTINE 1 Unknown 0 UNSPECIFIED
126421141 12642114 3 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Unknown 0 UNSPECIFIED
126421141 12642114 4 SS DEXAMETHASONE. DEXAMETHASONE 1 Unknown 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126421141 12642114 1 Acute lymphocytic leukaemia
126421141 12642114 2 Acute lymphocytic leukaemia
126421141 12642114 3 Acute lymphocytic leukaemia
126421141 12642114 4 Acute lymphocytic leukaemia

Outcome of event

Event ID CASEID OUTC COD
126421141 12642114 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
126421141 12642114 Off label use
126421141 12642114 Product use issue
126421141 12642114 Sepsis

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

no results found

Therapies reported

no results found