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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119327003 | 11932700 | 3 | F | 20160701 | 20160120 | 20160708 | EXP | US-JAZZ-2016-US-000677 | JAZZ | 0.00 | F | Y | 0.00000 | 20160708 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119327003 | 11932700 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 119327003 | 11932700 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 119327003 | 11932700 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 119327003 | 11932700 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 119327003 | 11932700 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 119327003 | 11932700 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 119327003 | 11932700 | 7 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | U | 0 | |||||||||||
| 119327003 | 11932700 | 8 | C | Imipramine | IMIPRAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119327003 | 11932700 | 9 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 119327003 | 11932700 | 10 | C | DIOVAN | VALSARTAN | 1 | UNK | U | 0 | TABLET | |||||||||
| 119327003 | 11932700 | 11 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119327003 | 11932700 | 1 | Narcolepsy |
| 119327003 | 11932700 | 2 | Cataplexy |
| 119327003 | 11932700 | 7 | Schizophrenia |
| 119327003 | 11932700 | 8 | Cataplexy |
| 119327003 | 11932700 | 9 | Cataplexy |
| 119327003 | 11932700 | 10 | Product used for unknown indication |
| 119327003 | 11932700 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119327003 | 11932700 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119327003 | 11932700 | Drug ineffective | |
| 119327003 | 11932700 | Schizophrenia |
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 |
|---|---|---|---|---|---|---|
| 119327003 | 11932700 | 1 | 200605 | 200607 | 0 | |
| 119327003 | 11932700 | 2 | 200607 | 200904 | 0 | |
| 119327003 | 11932700 | 3 | 200904 | 2009 | 0 | |
| 119327003 | 11932700 | 4 | 201110 | 201306 | 0 | |
| 119327003 | 11932700 | 5 | 201306 | 201312 | 0 | |
| 119327003 | 11932700 | 6 | 201312 | 2014 | 0 | |
| 119327003 | 11932700 | 8 | 20151107 | 0 | ||
| 119327003 | 11932700 | 9 | 20151107 | 0 | ||
| 119327003 | 11932700 | 10 | 20131210 | 20150101 | 0 | |
| 119327003 | 11932700 | 11 | 20010101 | 20010101 | 0 |