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
127396081 12739608 1 I 20160720 20160913 20160913 EXP RS-JNJFOC-20160728156 JANSSEN COLOVIC N. PERIPARTUM CARDIOMYOPATHY IN A PATIENT TREATED FOR ACUTE MYELOID LEUKEMIA. SRPSKI ARHIV ZA CELOKUPNO LEKARSTVO 2016;144(1-2):77-80. 30.00 YR A F Y 0.00000 20160913 OT RS RS

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
127396081 12739608 1 PS DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) ON DAY1, 3 AND 5 U U 50718 60 MG LIPOSOME INJECTION
127396081 12739608 2 SS ITRACONAZOLE. ITRACONAZOLE 1 Intravenous (not otherwise specified) U U 20083 UNSPECIFIED
127396081 12739608 3 SS FLUCONAZOLE. FLUCONAZOLE 1 Unknown U U 999999 UNSPECIFIED
127396081 12739608 4 SS MITOXANTRONE HCL MITOXANTRONE HYDROCHLORIDE 1 Intravenous (not otherwise specified) FROM D1 TO D4 U 0 15 MG UNKNOWN
127396081 12739608 5 SS VORICONAZOLE. VORICONAZOLE 1 Unknown U 0 UNSPECIFIED
127396081 12739608 6 SS AMPHOTERICIN B. AMPHOTERICIN B 1 Unknown U 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127396081 12739608 1 Acute myeloid leukaemia
127396081 12739608 2 Antifungal treatment
127396081 12739608 3 Antifungal treatment
127396081 12739608 4 Acute myeloid leukaemia
127396081 12739608 5 Antifungal treatment
127396081 12739608 6 Antifungal treatment

Outcome of event

Event ID CASEID OUTC COD
127396081 12739608 LT
127396081 12739608 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127396081 12739608 Off label use
127396081 12739608 Peripartum cardiomyopathy
127396081 12739608 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
127396081 12739608 4 200411 0