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
126432971 12643297 1 I 20160805 20160811 20160811 EXP IT-CIPLA LTD.-2016IT17074 CIPLA GRANDE R, GEMMA D, SPERDUTI I, GELIBTER A, GIAMPAOLO MA, TROMBETTA G ET AL.,. CHANGING MONOCLONAL ANTIBODY KEEPING UNALTERED THE CHEMOTHERAPY REGIMEN IN METASTATIC COLORECTAL CANCER PATIENTS: IS EFFICACY MAINTAINED?. SPRINGERPLUS. 2013;2:185 0.00 Y 0.00000 20160811 OT IT IT

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
126432971 12643297 1 PS Irinotecan IRINOTECAN 1 Intravenous (not otherwise specified) 180 MG/M2, OVER 90 MINUTES, DAY 1 U U 77219 180 MG/M**2
126432971 12643297 2 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous bolus 400 MG/M2, DAYS 1,2 U U 0 400 MG/M**2
126432971 12643297 3 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 1200 MG/M2/ DIE, OVER 46 HOURS U U 0 1200 MG/M**2
126432971 12643297 4 SS Folinic acid LEUCOVORIN 1 Intravenous (not otherwise specified) 100 MG/M2, DAY 1 TO 2 OVER 120 MINUTES U U 0 100 MG/M**2
126432971 12643297 5 SS Bevacizumab BEVACIZUMAB 1 Unknown 5 MG/KG, DAY1 U 0 5 MG/KG

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126432971 12643297 1 Colorectal cancer metastatic
126432971 12643297 2 Colorectal cancer metastatic
126432971 12643297 4 Colorectal cancer metastatic
126432971 12643297 5 Colorectal cancer metastatic

Outcome of event

Event ID CASEID OUTC COD
126432971 12643297 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
126432971 12643297 Disease progression

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

no results found

Therapies reported

no results found