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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944352 | 12494435 | 2 | F | 20160513 | 20160630 | 20160623 | 20160708 | PER | US-JAZZ-2016-US-011235 | JAZZ | 59.75 | YR | M | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944352 | 12494435 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124944352 | 12494435 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124944352 | 12494435 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124944352 | 12494435 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124944352 | 12494435 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | UNK | U | 21196 | ORAL SOLUTION | |||||||||
| 124944352 | 12494435 | 6 | C | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944352 | 12494435 | 7 | C | MOBIC | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944352 | 12494435 | 8 | C | Aspirin e.c | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944352 | 12494435 | 9 | C | Atorvastatin | ATORVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944352 | 12494435 | 10 | C | MINOXIDIL. | MINOXIDIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944352 | 12494435 | 11 | C | EPIPEN | EPINEPHRINE | 1 | UNK | U | 0 | ||||||||||
| 124944352 | 12494435 | 12 | C | Fluoxetine hcl | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124944352 | 12494435 | 13 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944352 | 12494435 | 14 | C | LORATADINE. | LORATADINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944352 | 12494435 | 15 | C | NASONEX | MOMETASONE FUROATE | 1 | UNK | U | 0 | NASAL SPRAY |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124944352 | 12494435 | 1 | Narcolepsy |
| 124944352 | 12494435 | 2 | Cataplexy |
| 124944352 | 12494435 | 6 | Product used for unknown indication |
| 124944352 | 12494435 | 7 | Product used for unknown indication |
| 124944352 | 12494435 | 8 | Product used for unknown indication |
| 124944352 | 12494435 | 9 | Product used for unknown indication |
| 124944352 | 12494435 | 10 | Product used for unknown indication |
| 124944352 | 12494435 | 11 | Product used for unknown indication |
| 124944352 | 12494435 | 12 | Product used for unknown indication |
| 124944352 | 12494435 | 13 | Product used for unknown indication |
| 124944352 | 12494435 | 14 | Product used for unknown indication |
| 124944352 | 12494435 | 15 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124944352 | 12494435 | Hand fracture | |
| 124944352 | 12494435 | 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 |
|---|---|---|---|---|---|---|
| 124944352 | 12494435 | 1 | 201212 | 2012 | 0 | |
| 124944352 | 12494435 | 2 | 201212 | 201402 | 0 | |
| 124944352 | 12494435 | 3 | 201402 | 0 | ||
| 124944352 | 12494435 | 6 | 20160118 | 0 | ||
| 124944352 | 12494435 | 7 | 20160118 | 0 | ||
| 124944352 | 12494435 | 8 | 20150715 | 0 | ||
| 124944352 | 12494435 | 9 | 20150715 | 0 | ||
| 124944352 | 12494435 | 10 | 20150715 | 0 | ||
| 124944352 | 12494435 | 11 | 20121101 | 0 | ||
| 124944352 | 12494435 | 12 | 20121101 | 0 | ||
| 124944352 | 12494435 | 13 | 20121101 | 0 | ||
| 124944352 | 12494435 | 14 | 20120801 | 0 | ||
| 124944352 | 12494435 | 15 | 20120801 | 0 |