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
126066912 12606691 2 F 20160808 20160729 20160820 EXP JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-121185 RANBAXY OSAWA G, YOSHIMATSU K, YOKOMIZO H, OTANI T, YANO Y, ITAGAKI H, ET AL. A CASE OF MULTIPLE LUNG AND LIVER METASTASES FROM COLON CANCER TREATED WITH CLINICAL BENEFIT BY HEPATIC ARTERIAL INFUSION CHEMOTHERAPY PLUS CETUXIMAB MONO-THERAPY AFTER STANDARD CHEMOTHERAPY FAILURE. GAN-TO-KAGAKU-RYOHO. 2010;37 (12):2526-2528 61.00 YR F Y 0.00000 20160820 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
126066912 12606691 1 PS OXALIPLATIN. OXALIPLATIN 1 Unknown FIRST LINE THERAPY U 202922
126066912 12606691 2 SS OXALIPLATIN. OXALIPLATIN 1 U 202922
126066912 12606691 3 SS Irinotecan IRINOTECAN 1 Unknown SECOND LINE THERAPY U U 0
126066912 12606691 4 SS Irinotecan IRINOTECAN 1 Unknown THIRD LINE THERAPY U U 0
126066912 12606691 5 SS Calcium folinat LEUCOVORIN CALCIUM 1 Unknown FIRST LINE THERAPY U U 0
126066912 12606691 6 SS Calcium folinat LEUCOVORIN CALCIUM 1 Unknown THIRD LINE THERAPY U U 0
126066912 12606691 7 SS Bevacizumab BEVACIZUMAB 1 Unknown FIRST LINE THERAPY U U 0
126066912 12606691 8 SS Bevacizumab BEVACIZUMAB 1 Unknown SECOND LINE THERAPY U U 0
126066912 12606691 9 SS FLUOROURACIL. FLUOROURACIL 1 Unknown FIRST AND SECOND LINE THERAPY U U 0
126066912 12606691 10 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 1000 MG/M2, 1/WEEK U U 0 1000 MG/M**2 /wk
126066912 12606691 11 SS Cetuximab CETUXIMAB 1 Unknown THIRD-LINE THERAPY U U 0
126066912 12606691 12 SS Cetuximab CETUXIMAB 1 U U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126066912 12606691 1 Colon cancer
126066912 12606691 2 Metastasis
126066912 12606691 3 Colon cancer
126066912 12606691 4 Metastasis
126066912 12606691 5 Colon cancer
126066912 12606691 6 Metastasis
126066912 12606691 7 Metastasis
126066912 12606691 8 Colon cancer
126066912 12606691 9 Metastasis
126066912 12606691 10 Colon cancer
126066912 12606691 11 Metastasis
126066912 12606691 12 Colon cancer

Outcome of event

Event ID CASEID OUTC COD
126066912 12606691 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
126066912 12606691 Anaemia
126066912 12606691 Disease progression
126066912 12606691 Malaise
126066912 12606691 Performance status decreased
126066912 12606691 Therapeutic response decreased

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
126066912 12606691 1 200804 0
126066912 12606691 3 200905 0
126066912 12606691 4 200908 0
126066912 12606691 5 200804 0
126066912 12606691 6 200905 0
126066912 12606691 7 200804 0
126066912 12606691 8 200905 0
126066912 12606691 9 200804 0
126066912 12606691 11 200908 0