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 |