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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126454081 | 12645408 | 1 | I | 20140306 | 20160811 | 20160811 | PER | US-JAZZ-2014-US-002902 | JAZZ | 0.00 | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126454081 | 12645408 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 3082256 | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126454081 | 12645408 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126454081 | 12645408 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 3117614 | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126454081 | 12645408 | 4 | SS | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 126454081 | 12645408 | 5 | SS | PROVIGIL | MODAFINIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126454081 | 12645408 | 1 | Narcolepsy |
| 126454081 | 12645408 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126454081 | 12645408 | Exposure during pregnancy | |
| 126454081 | 12645408 | Postural orthostatic tachycardia syndrome | |
| 126454081 | 12645408 | Pre-existing condition improved | |
| 126454081 | 12645408 | 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 |
|---|---|---|---|---|---|---|
| 126454081 | 12645408 | 1 | 201012 | 2010 | 0 | |
| 126454081 | 12645408 | 3 | 201303 | 20140218 | 0 |