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
124325432 12432543 2 F 20160630 20160603 20160715 EXP JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-117803 RANBAXY HIRANO A, KODA K, SUZUKI M, YAMAZAKI M, TEZUKA T, KOSUGI C, ET AL. EVALUATION OF MODIFIED OPTIMOX1 PLUS BEVACIZUMAB AS THE NEOADJUVANT THERAPY FOR HIGHLY ADVANCED RECTAL CANCERS. GAN-TO-KAGAKU-RYOHO. 2012;39 (7):1087-1091 50.00 YR F Y 0.00000 20160715 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
124325432 12432543 1 SS Calcium folinat LEUCOVORIN CALCIUM 1 Parenteral 200 MG/M2/2 HOURS, CYCLICAL U U 0 200 MG/M**2
124325432 12432543 2 SS 5-Fluorouracil FLUOROURACIL 1 Parenteral 400 MG/M2/BOLUS, CYCLICAL U U 0 400 MG/M**2
124325432 12432543 3 SS 5-Fluorouracil FLUOROURACIL 1 Parenteral 2400 MG/M2/46 HOURS, UNK U U 0 2400 MG/M**2
124325432 12432543 4 PS OXALIPLATIN. OXALIPLATIN 1 Parenteral 85 MG/M2/2 HOURS, CYCLICAL U U 202922 85 MG/M**2
124325432 12432543 5 SS Bevacizumab BEVACIZUMAB 1 Parenteral 5 MG/KG/30MIN, CYCLICAL U U 0 5 MG/KG

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
124325432 12432543 1 Rectal cancer
124325432 12432543 2 Rectal cancer
124325432 12432543 3 Rectal cancer
124325432 12432543 4 Rectal cancer
124325432 12432543 5 Rectal cancer

Outcome of event

Event ID CASEID OUTC COD
124325432 12432543 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
124325432 12432543 Disease progression
124325432 12432543 Female genital tract fistula
124325432 12432543 Neurotoxicity

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

no results found

Therapies reported

no results found