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
127159282 12715928 2 F 20160907 20160906 20160919 EXP JP-ACCORD-043801 ACCORD MIYAMAE Y, SHIMIZU H, NAGANUMA A, AIBA M, TANAKA T, OGAWA T, ET AL. (A CASE OF RECTAL NEUROENDOCRINE CARCINOMA WITH METACHRONOUS LIVER METASTASIS TREATED WITH MULTIMODALITY THERAPY). GAN TO KAGAKU RYOHO. 2016 AUG;43(8):1009-13. 62.00 YR F Y 0.00000 20160919 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
127159282 12715928 1 PS FLUOROURACIL. FLUOROURACIL 1 Intravenous bolus FOLFOX4, BOLUS 400 MG/M2 DAY 1 OR 2, CHANGED TO CONTINUOUS INFUSION 600 MG/M2 22 HR DAY 1 OR 2 U 40743 400 MG/M**2 INFUSION
127159282 12715928 2 SS IRINOTECAN IRINOTECAN 1 1 COURSE OF 28 DAYS, DAY 1, 8, 15 U 79068 50 MG/M**2
127159282 12715928 3 SS CARBOPLATIN. CARBOPLATIN 1 1 COURSE OF 28 DAYS, AUC5 DAY 1 U 0
127159282 12715928 4 SS OXALIPLATIN. OXALIPLATIN 1 FOLFOX4, 1 COURSE OF 14 DAYS, 85 MG/M2 DAY 1 OR 2 0 85 MG/M**2
127159282 12715928 5 SS PANITUMUMAB PANITUMUMAB 1 1 COURSE OF 14 DAYS, 6 MG/KG DAY 1 0 6 MG/KG
127159282 12715928 6 SS BEVACIZUMAB BEVACIZUMAB 1 1 COURSE OF 14 DAYS, 5 MG/KG (2 COURSE DAY FROM 10 MG/KG) DAY 1 U 0 5 MG/KG
127159282 12715928 7 C FOLINIC ACID LEUCOVORIN 1 FOLFOX4 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127159282 12715928 1 Rectal cancer
127159282 12715928 2 Rectal cancer
127159282 12715928 3 Rectal cancer
127159282 12715928 4 Rectal cancer
127159282 12715928 5 Rectal cancer
127159282 12715928 6 Rectal cancer
127159282 12715928 7 Rectal cancer

Outcome of event

Event ID CASEID OUTC COD
127159282 12715928 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127159282 12715928 Bone marrow failure
127159282 12715928 Dermatitis acneiform
127159282 12715928 Neuropathy peripheral
127159282 12715928 Neutropenia
127159282 12715928 Paronychia

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
127159282 12715928 1 201201 0
127159282 12715928 2 201109 0
127159282 12715928 3 201109 0
127159282 12715928 4 201201 0
127159282 12715928 5 201201 0
127159282 12715928 6 201206 0