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
114794082 11479408 2 F 20110323 20160906 20150909 20160927 PER FR-JAZZ-JPI-P-015918 JAZZ 0.00 M Y 96.00000 KG 20160927 CN FR FR

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
114794082 11479408 1 PS XYREM SODIUM OXYBATE 1 Oral 2.25 G, BID 76.7740021 G 21196 2.25 G ORAL SOLUTION
114794082 11479408 2 SS XYREM SODIUM OXYBATE 1 Oral 3.75 G, BID 76.7740021 G 21196 3.75 G ORAL SOLUTION
114794082 11479408 3 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, BID 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 4 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G FIRST DOSE/3 G SECOND DOSE 76.7740021 G 21196 ORAL SOLUTION
114794082 11479408 5 SS XYREM SODIUM OXYBATE 1 Oral TOOK ONLY FIRST DOSE 4.5 GRAM 76.7740021 G 21196 ORAL SOLUTION
114794082 11479408 6 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, BID 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 7 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G FIRST DOSE/3 G SECOND DOSE 76.7740021 G 21196 ORAL SOLUTION
114794082 11479408 8 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G FIRST DOSE/3 G SECOND DOSE 76.7740021 G 21196 ORAL SOLUTION
114794082 11479408 9 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G FIRST DOSE/3 G SECOND DOSE 76.7740021 G 21196 ORAL SOLUTION
114794082 11479408 10 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G FIRST DOSE/3 G SECOND DOSE 76.7740021 G 21196 ORAL SOLUTION
114794082 11479408 11 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G FIRST DOSE/3 G SECOND DOSE 76.7740021 G 21196 ORAL SOLUTION
114794082 11479408 12 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, BID 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 13 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, BID 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 14 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, QD 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 15 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, BID 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 16 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G , QD 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 17 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G , BID 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 18 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G , QD 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 19 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, BID 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 20 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, FIRST DOSE 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 21 SS XYREM SODIUM OXYBATE 1 Oral 3 G, SECOND DOSE 76.7740021 G 21196 3 G ORAL SOLUTION
114794082 11479408 22 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, FIRST DOSE 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 23 SS XYREM SODIUM OXYBATE 1 Oral 3.5 G, SECOND DOSE 76.7740021 G 21196 3.5 G ORAL SOLUTION
114794082 11479408 24 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, FIRST DOSE 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 25 SS XYREM SODIUM OXYBATE 1 Oral 3 G, SECOND DOSE 76.7740021 G 21196 3 G ORAL SOLUTION
114794082 11479408 26 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, FIRST DOSE 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 27 SS XYREM SODIUM OXYBATE 1 Oral 3 G, SECOND DOSE 76.7740021 G 21196 3 G ORAL SOLUTION
114794082 11479408 28 SS XYREM SODIUM OXYBATE 1 Oral 4 G, FIRST DOSE 76.7740021 G 21196 4 G ORAL SOLUTION
114794082 11479408 29 SS XYREM SODIUM OXYBATE 1 Oral 3 G, SECOND DOSE 76.7740021 G 21196 3 G ORAL SOLUTION
114794082 11479408 30 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, FIRST DOSE 76.7740021 G 21196 4.5 G ORAL SOLUTION
114794082 11479408 31 SS XYREM SODIUM OXYBATE 1 Oral 3 G, SECOND DOSE 76.7740021 G 21196 3 G ORAL SOLUTION
114794082 11479408 32 C Ritaline LP METHYLPHENIDATE HYDROCHLORIDE 1 UNK, BID U 0
114794082 11479408 33 C EFFEXOR VENLAFAXINE HYDROCHLORIDE 1 U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
114794082 11479408 1 Narcolepsy

Outcome of event

no results found

Reactions reported

Event ID CASEID DRUG REC ACT PT
114794082 11479408 Asthenia
114794082 11479408 Drug administration error
114794082 11479408 Drug ineffective
114794082 11479408 Enuresis
114794082 11479408 Exercise tolerance decreased
114794082 11479408 Fatigue
114794082 11479408 Feeling abnormal
114794082 11479408 Malaise
114794082 11479408 Treatment noncompliance
114794082 11479408 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
114794082 11479408 1 20110322 20110421 0
114794082 11479408 2 20110422 20110526 0
114794082 11479408 3 20110527 2011 0
114794082 11479408 4 20110801 20111109 0
114794082 11479408 5 20111110 20111118 0
114794082 11479408 6 20111119 20111222 0
114794082 11479408 7 20120704 20120805 0
114794082 11479408 8 20120806 20120916 0
114794082 11479408 9 20121030 20121128 0
114794082 11479408 10 20121129 0
114794082 11479408 11 20130216 20130329 0
114794082 11479408 12 20130330 20130507 0
114794082 11479408 13 20130507 20130511 0
114794082 11479408 14 20130512 2013 0
114794082 11479408 15 20130710 20130718 0
114794082 11479408 16 20130719 20130719 0
114794082 11479408 17 20130720 20130726 0
114794082 11479408 18 20130727 20130727 0
114794082 11479408 19 20130728 20131012 0
114794082 11479408 20 20131013 20131028 0
114794082 11479408 21 20131013 20131028 0
114794082 11479408 22 20131106 20131206 0
114794082 11479408 23 20131106 20131206 0
114794082 11479408 24 20131220 20140214 0
114794082 11479408 25 20131220 20140214 0
114794082 11479408 26 20140328 0
114794082 11479408 27 20140328 0
114794082 11479408 28 20150909 20150916 0
114794082 11479408 29 20150909 20150916 0
114794082 11479408 30 20150917 0
114794082 11479408 31 20150917 0