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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238661 | 12523866 | 1 | I | 201512 | 20151221 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022293 | JAZZ | 39.38 | YR | F | Y | 0.00000 | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238661 | 12523866 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125238661 | 12523866 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125238661 | 12523866 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125238661 | 12523866 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, SECOND DOSE | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 125238661 | 12523866 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, THIRD DOSE | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 125238661 | 12523866 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125238661 | 12523866 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125238661 | 12523866 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125238661 | 12523866 | 9 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, SECOND DOSE | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 125238661 | 12523866 | 10 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, THIRD DOSE | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 125238661 | 12523866 | 11 | SS | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | U | 0 | SUPPOSITORY | ||||||||||
| 125238661 | 12523866 | 12 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238661 | 12523866 | 13 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238661 | 12523866 | 14 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238661 | 12523866 | 15 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 125238661 | 12523866 | 16 | C | NAPROXEN. | NAPROXEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238661 | 12523866 | 17 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238661 | 12523866 | 18 | C | Calcium | CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238661 | 12523866 | 19 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 125238661 | 12523866 | 20 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125238661 | 12523866 | 1 | Narcolepsy |
| 125238661 | 12523866 | 2 | Cataplexy |
| 125238661 | 12523866 | 11 | Product used for unknown indication |
| 125238661 | 12523866 | 12 | Product used for unknown indication |
| 125238661 | 12523866 | 13 | Product used for unknown indication |
| 125238661 | 12523866 | 14 | Product used for unknown indication |
| 125238661 | 12523866 | 15 | Product used for unknown indication |
| 125238661 | 12523866 | 16 | Product used for unknown indication |
| 125238661 | 12523866 | 17 | Product used for unknown indication |
| 125238661 | 12523866 | 18 | Product used for unknown indication |
| 125238661 | 12523866 | 19 | Product used for unknown indication |
| 125238661 | 12523866 | 20 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125238661 | 12523866 | Drug hypersensitivity |
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 |
|---|---|---|---|---|---|---|
| 125238661 | 12523866 | 1 | 201007 | 201008 | 0 | |
| 125238661 | 12523866 | 3 | 201205 | 2013 | 0 | |
| 125238661 | 12523866 | 4 | 201205 | 2013 | 0 | |
| 125238661 | 12523866 | 5 | 201205 | 2013 | 0 | |
| 125238661 | 12523866 | 6 | 201401 | 2014 | 0 | |
| 125238661 | 12523866 | 8 | 201407 | 0 | ||
| 125238661 | 12523866 | 9 | 201407 | 0 | ||
| 125238661 | 12523866 | 10 | 201407 | 0 | ||
| 125238661 | 12523866 | 12 | 20151124 | 0 | ||
| 125238661 | 12523866 | 13 | 20150320 | 0 | ||
| 125238661 | 12523866 | 14 | 20131226 | 0 | ||
| 125238661 | 12523866 | 15 | 20131201 | 0 | ||
| 125238661 | 12523866 | 16 | 20130101 | 0 | ||
| 125238661 | 12523866 | 17 | 20100601 | 0 | ||
| 125238661 | 12523866 | 18 | 20100101 | 0 | ||
| 125238661 | 12523866 | 19 | 20100101 | 0 | ||
| 125238661 | 12523866 | 20 | 20100101 | 0 |