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
125861581 12586158 1 I 20160205 20160725 20160725 PER US-JAZZ-2016-US-002277 JAZZ 0.00 F Y 0.00000 20160725 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
125861581 12586158 1 PS XYREM SODIUM OXYBATE 1 Oral 2.25 G, BID 21196 2.25 G ORAL SOLUTION
125861581 12586158 2 SS XYREM SODIUM OXYBATE 1 Oral DOSE ADJUSTMENTS 21196 ORAL SOLUTION
125861581 12586158 3 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, BID 21196 4.5 G ORAL SOLUTION
125861581 12586158 4 SS NUVIGIL ARMODAFINIL 1 UNK Y 0 TABLET
125861581 12586158 5 C CONCERTA METHYLPHENIDATE HYDROCHLORIDE 1 UNK U 0 TABLET

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125861581 12586158 1 Narcolepsy
125861581 12586158 2 Cataplexy
125861581 12586158 4 Product used for unknown indication
125861581 12586158 5 Product used for unknown indication

Outcome of event

no results found

Reactions reported

Event ID CASEID DRUG REC ACT PT
125861581 12586158 Unevaluable event

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
125861581 12586158 1 201207 201207 0
125861581 12586158 3 201501 0
125861581 12586158 4 20120512 20151001 0