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
127871661 12787166 1 I 20160921 0 20160927 20160927 DIR FDA-CTU 56.00 YR F N 0.00000 20160927 N PH US US

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
127871661 12787166 1 PS GLEEVEC IMATINIB MESYLATE 1 Oral 1 TAB QD PO D D F0036 20181231 0 1 DF COATED TABLET QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127871661 12787166 1 Leukaemia

Outcome of event

Event ID CASEID OUTC COD
127871661 12787166 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
127871661 12787166 Abdominal pain
127871661 12787166 Bone pain
127871661 12787166 Nausea
127871661 12787166 Pyrexia
127871661 12787166 Vomiting

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

Event ID CASEID RPSR COD
127871661 12787166 HP

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
127871661 12787166 1 20160916 0