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
127801671 12780167 1 I 0 20160923 20160923 DIR US-FDA-351427 FDA-CTU 35.00 YR F N 0.00000 20160923 N OT 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
127801671 12780167 1 PS CREON PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE 1 Oral 24,000 UNITS ORAL D D 0 24000 DF
127801671 12780167 2 SS PULMOZYME DORNASE ALFA 1 Respiratory (inhalation) D D 0 BID

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127801671 12780167 1 Cystic fibrosis
127801671 12780167 2 Cystic fibrosis

Outcome of event

Event ID CASEID OUTC COD
127801671 12780167 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
127801671 12780167 Abdominal pain

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

Event ID CASEID RPSR COD
127801671 12780167 HP

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
127801671 12780167 1 20150703 0
127801671 12780167 2 20150605 0