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
125394663 12539466 3 F 20130204 20160823 20160708 20160825 EXP JP-AMGEN-JPNSP2016088202 AMGEN TSUDA M, AKAZAWA S, DAIZUMOTO K ET AL.. EXPERIENCES OF USE OF DENOSUMAB FOR UROLOGIC CANCERS METASTASIS TO THE BONE. THE 104TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION. 2016 85.00 YR E M Y 62.00000 KG 20160825 MD 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
125394663 12539466 1 PS RANMARK DENOSUMAB 1 Subcutaneous 120 MG, UNK 125320 120 MG SOLUTION FOR INJECTION
125394663 12539466 2 SS ZOLEDRONIC ACID ZOLEDRONIC ACID 1 Unknown UNK 0
125394663 12539466 3 C CALCIUM LACTATE CALCIUM LACTATE 1 Oral 1 G, TID 1485 G 0 1 G TID
125394663 12539466 4 C ALFAROL ALFACALCIDOL 1 Oral 0.5 MUG, QD 0 .5 UG CAPSULE QD
125394663 12539466 5 C CELECOX CELECOXIB 1 Oral 100 MG, BID 99000 MG 0 100 MG TABLET BID
125394663 12539466 6 C KREMEZIN ACTIVATED CHARCOAL 1 Oral 2 G, TID 2466 G 0 2 G TID
125394663 12539466 7 C KREMEZIN ACTIVATED CHARCOAL 1 2466 G 0
125394663 12539466 8 C NORVASC AMLODIPINE BESYLATE 1 Oral 5 MG, QD 0 5 MG ORODISPERSIBLE TABLET QD
125394663 12539466 9 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 5 MG, BID 0 5 MG BID
125394663 12539466 10 C NEXAVAR SORAFENIB 1 UNK 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125394663 12539466 1 Renal cancer
125394663 12539466 2 Product used for unknown indication
125394663 12539466 3 Hypocalcaemia
125394663 12539466 4 Hypocalcaemia
125394663 12539466 5 Bone pain
125394663 12539466 6 Chronic kidney disease
125394663 12539466 7 Chronic kidney disease
125394663 12539466 8 Hypertension
125394663 12539466 9 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
125394663 12539466 OT
125394663 12539466 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
125394663 12539466 Osteonecrosis of jaw
125394663 12539466 Pneumonia

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
125394663 12539466 1 20120803 20130823 0
125394663 12539466 2 20120604 0
125394663 12539466 3 20120116 20130524 0
125394663 12539466 4 20120803 0
125394663 12539466 5 20111128 20130405 0
125394663 12539466 6 20120604 20130719 0
125394663 12539466 8 2006 0
125394663 12539466 10 20120604 0