The Safety Rates Drug Report

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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
125396111 12539611 1 I 20160601 20160708 20160708 EXP JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-119825 RANBAXY GOTO A, ITOH M, WAKASUGI H, KANNO S, YABANA T, MITSUHASHI K, ET AL. A CASE OF RECURRENT GASTRIC CANCER SHOWING PARTIAL RESPONSE TO CAPECITABINE/CDDP AFTER TREATMENT WITH S-1/ CDDP. GAN-TO-KAGAKU-RYOHO. 2012;39(10):1563-1566 71.00 YR M Y 55.00000 KG 20160708 OT 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
125396111 12539611 1 SS CAPECITABINE. CAPECITABINE 1 Unknown 3000 MG, DAILY, ON DAY 1-14 U 0 3000 MG
125396111 12539611 2 SS CISPLATIN. CISPLATIN 1 Unknown 60 MG/M2, Q3WKS, ON DAY 1 U U 0 60 MG/M**2
125396111 12539611 3 C CAPECITABINE. CAPECITABINE 1 Unknown 2400 MG, DAILY U U 0 2400 MG
125396111 12539611 4 PS Irinotecan IRINOTECAN 1 Unknown 150 MG/M2, FORTNIGHT U U 78805 150 MG/M**2
125396111 12539611 5 SS PACLITAXEL. PACLITAXEL 1 Unknown 80 MG/M2, ON DAY 1,8, 15, Q4WKS U U 0 80 MG/M**2
125396111 12539611 6 SS DOCETAXEL. DOCETAXEL 1 Unknown 60 MG/M2, Q3WKS U U 0 60 MG/M**2

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125396111 12539611 1 Gastric cancer stage III
125396111 12539611 2 Gastric cancer stage III
125396111 12539611 3 Gastric cancer stage III
125396111 12539611 4 Gastric cancer stage III
125396111 12539611 5 Gastric cancer stage III
125396111 12539611 6 Gastric cancer stage III

Outcome of event

Event ID CASEID OUTC COD
125396111 12539611 HO
125396111 12539611 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125396111 12539611 Decreased appetite
125396111 12539611 Disease progression
125396111 12539611 Drug effect incomplete
125396111 12539611 Nausea

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
125396111 12539611 1 20110614 0
125396111 12539611 2 20110614 0
125396111 12539611 4 20090907 0
125396111 12539611 5 20091212 0
125396111 12539611 6 20100311 0