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
124717483 12471748 3 F 20160422 20160712 20160616 20160718 EXP FR-JNJFOC-20160607425 JANSSEN 59.30 YR A F Y 0.00000 20160718 OT FR FR

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
124717483 12471748 1 SS CAELYX DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) N N 0 33 MG LIPOSOME INJECTION
124717483 12471748 2 SS CAELYX DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) N N 0 33 MG LIPOSOME INJECTION
124717483 12471748 3 SS CAELYX DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) FIRST COURSE, 33 MG N N 0 20 MG/KG LIPOSOME INJECTION
124717483 12471748 4 PS CAELYX DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) SECOND COURSE, 33 MG N N 50718 20 MG/KG LIPOSOME INJECTION
124717483 12471748 5 SS GEMZAR GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) FIRST COURSE, 1640MG PER INTAKE ON D1, D8, D15 0 1000 MG/M**2 UNSPECIFIED
124717483 12471748 6 SS GEMZAR GEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) SECOND COURSE, 1640MG PER INTAKE ON D1, D8, D15 0 1000 MG/M**2 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
124717483 12471748 1 Lymphoma
124717483 12471748 2 Lymphoma
124717483 12471748 3 Lymphoma
124717483 12471748 4 Lymphoma
124717483 12471748 5 Lymphoma
124717483 12471748 6 Lymphoma

Outcome of event

Event ID CASEID OUTC COD
124717483 12471748 DS

Reactions reported

Event ID CASEID DRUG REC ACT PT
124717483 12471748 Neuropathy peripheral
124717483 12471748 Off label use
124717483 12471748 Product use issue

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

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
124717483 12471748 1 20160603 0
124717483 12471748 2 20160617 0
124717483 12471748 3 20160422 0
124717483 12471748 4 20160506 0
124717483 12471748 5 20160226 20160311 0
124717483 12471748 6 20160325 20160408 0