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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125860221 | 12586022 | 1 | I | 20160202 | 20160725 | 20160725 | PER | US-JAZZ-2016-US-001964 | JAZZ | 0.00 | M | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125860221 | 12586022 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125860221 | 12586022 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125860221 | 12586022 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125860221 | 12586022 | 4 | SS | NUVIGIL | ARMODAFINIL | 1 | UNK | 0 | TABLET | ||||||||||
| 125860221 | 12586022 | 5 | C | ADVIL | IBUPROFEN | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125860221 | 12586022 | 1 | Narcolepsy |
| 125860221 | 12586022 | 2 | Cataplexy |
| 125860221 | 12586022 | 4 | Product used for unknown indication |
| 125860221 | 12586022 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125860221 | 12586022 | Fatigue | |
| 125860221 | 12586022 | Headache | |
| 125860221 | 12586022 | Impaired driving ability |
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 |
|---|---|---|---|---|---|---|
| 125860221 | 12586022 | 1 | 201510 | 201510 | 0 | |
| 125860221 | 12586022 | 3 | 201511 | 0 | ||
| 125860221 | 12586022 | 4 | 20150923 | 0 | ||
| 125860221 | 12586022 | 5 | 20150930 | 0 |