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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114730242 | 11473024 | 2 | F | 2014 | 20160805 | 20150908 | 20160812 | EXP | US-JAZZ-2014-US-008302 | JAZZ | 0.00 | F | Y | 0.00000 | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114730242 | 11473024 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 3118404 | 21196 | 2.25 | G | ORAL SOLUTION | |||||
| 114730242 | 11473024 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 114730242 | 11473024 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 3118406 | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 114730242 | 11473024 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DECREASED DOSE | Y | 21196 | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114730242 | 11473024 | 1 | Narcolepsy |
| 114730242 | 11473024 | 2 | Somnolence |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114730242 | 11473024 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114730242 | 11473024 | Bipolar disorder | |
| 114730242 | 11473024 | Depression | |
| 114730242 | 11473024 | Incorrect dose administered |
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 |
|---|---|---|---|---|---|---|
| 114730242 | 11473024 | 1 | 201406 | 2014 | 0 | |
| 114730242 | 11473024 | 2 | 2014 | 2014 | 0 | |
| 114730242 | 11473024 | 3 | 2014 | 0 |