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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126453861 | 12645386 | 1 | I | 20140609 | 20160811 | 20160811 | PER | US-JAZZ-2014-US-007262 | JAZZ | 0.00 | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126453861 | 12645386 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 3097762 | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126453861 | 12645386 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 3097762 | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126453861 | 12645386 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 3118402 | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126453861 | 12645386 | 4 | SS | PROVIGIL | MODAFINIL | 1 | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126453861 | 12645386 | 1 | Cataplexy |
| 126453861 | 12645386 | 2 | Narcolepsy |
| 126453861 | 12645386 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126453861 | 12645386 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126453861 | 12645386 | Anxiety | |
| 126453861 | 12645386 | Depression | |
| 126453861 | 12645386 | Dyspnoea | |
| 126453861 | 12645386 | Feeling hot | |
| 126453861 | 12645386 | Hepatic enzyme increased | |
| 126453861 | 12645386 | Mental impairment |
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 |
|---|---|---|---|---|---|---|
| 126453861 | 12645386 | 1 | 201207 | 201207 | 0 | |
| 126453861 | 12645386 | 2 | 201207 | 201208 | 0 | |
| 126453861 | 12645386 | 3 | 201208 | 2015 | 0 |