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
126078001 12607800 1 I 20160726 20160729 20160729 EXP JP-JNJFOC-20160723360 JANSSEN IKEHATA Y, TANAKA T, ICHIHARA K, KOBAYASHI K, KITAMURA H, TAKAHASHI S, ET AL. INCIDENCE AND RISK FACTORS FOR ACUTE KIDNEY INJURY AFTER RADICAL CYSTECTOMY. INTERNATIONAL JOURNAL OF UROLOGY 01-JUL-2016;23/7:558-563. 0.00 Y 0.00000 20160729 MD JP JP

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
126078001 12607800 1 PS DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE 1 Unknown U U 50718 LIPOSOME INJECTION
126078001 12607800 2 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Unknown U 0 UNSPECIFIED
126078001 12607800 3 SS CISPLATIN. CISPLATIN 1 Unknown U 0 UNSPECIFIED
126078001 12607800 4 SS METHOTREXATE. METHOTREXATE 1 Unknown U 0 UNSPECIFIED
126078001 12607800 5 SS VINBLASTIN VINBLASTINE 1 Unknown U 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126078001 12607800 1 Bladder cancer
126078001 12607800 2 Bladder cancer
126078001 12607800 3 Bladder cancer
126078001 12607800 4 Bladder cancer
126078001 12607800 5 Bladder cancer

Outcome of event

Event ID CASEID OUTC COD
126078001 12607800 OT
126078001 12607800 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
126078001 12607800 Acute kidney injury
126078001 12607800 Off label use
126078001 12607800 Product use issue

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

no results found

Therapies reported

no results found