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
126364101 12636410 1 I 201509 20160725 20160809 20160809 EXP JP-ACCORD-042972 ACCORD KIBA T, SAITO Y, OTOMO C, SATO M, MEGURO T. [A PANCREATIC CANCER PATIENT IN WHOM PEGFILGRASTIM PROPHYLAXIS DID NOT PREVENT SEVERE NEUTROPENIA CAUSED BY THE FOLFIRINOX REGIMEN]. GAN TO KAGAKU RYOHO. 2016 JUL;43(7):913-5. 62.00 YR M Y 0.00000 20160809 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
126364101 12636410 1 PS FLUOROURACIL. FLUOROURACIL 1 (BOLUS) 400 MG/M2, (CONTINUOUS INFUSION) 2,400 MG/M2 WAS INITIATED IN THE STANDARD THERAPEUTIC DOSE Y 40743 2400 MG/M**2
126364101 12636410 2 SS GEMCITABINE/GEMCITABINE HYDROCHLORIDE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 14 COURSES WAS PERFORMED U 91594 1000 MG/M**2
126364101 12636410 3 SS IRINOTECAN IRINOTECAN 1 DOSE ADMITTED 65% DOSE AS 150 MG/BODY Y 79068
126364101 12636410 4 SS OXALIPLATIN. OXALIPLATIN 1 65% OF DOSE AS 85MG/BODY, Y 0
126364101 12636410 5 SS CALCIUM LEVOFOLINATE LEVOLEUCOVORIN CALCIUM 1 Y 0 200 MG/M**2
126364101 12636410 6 SS PACLITAXEL/PACLITAXEL LIPOSOME PACLITAXEL 1 3 WEEKS ADMINISTRATION WITH 1 WEEK REST DRUG??NAB-PACLITAXEL U 0 125 MG/M**2

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126364101 12636410 1 Pancreatic carcinoma
126364101 12636410 2 Pancreatic carcinoma
126364101 12636410 3 Pancreatic carcinoma
126364101 12636410 4 Pancreatic carcinoma
126364101 12636410 5 Pancreatic carcinoma
126364101 12636410 6 Pancreatic carcinoma

Outcome of event

Event ID CASEID OUTC COD
126364101 12636410 HO
126364101 12636410 LT

Reactions reported

Event ID CASEID DRUG REC ACT PT
126364101 12636410 Febrile neutropenia
126364101 12636410 Gait disturbance
126364101 12636410 Neutropenia

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

no results found

Therapies reported

no results found