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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114741442 | 11474144 | 2 | F | 200809 | 20160718 | 20150908 | 20160725 | EXP | US-JAZZ-2013-US-002155 | JAZZ | 41.00 | YR | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114741442 | 11474144 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.25 G, BID | U | 3067655 | 21196 | 1.25 | G | ORAL SOLUTION | |||||
| 114741442 | 11474144 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 3067655 | 21196 | 2.25 | G | ORAL SOLUTION | |||||
| 114741442 | 11474144 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 3117614 | 21196 | 3 | G | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114741442 | 11474144 | 1 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114741442 | 11474144 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114741442 | 11474144 | Balance disorder | |
| 114741442 | 11474144 | Insomnia | |
| 114741442 | 11474144 | Memory impairment | |
| 114741442 | 11474144 | Muscle spasms | |
| 114741442 | 11474144 | Muscular weakness | |
| 114741442 | 11474144 | Nerve injury | |
| 114741442 | 11474144 | Pain | |
| 114741442 | 11474144 | Product use issue | |
| 114741442 | 11474144 | Restless legs syndrome | |
| 114741442 | 11474144 | Spinal cord injury |
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 |
|---|---|---|---|---|---|---|
| 114741442 | 11474144 | 1 | 200809 | 200809 | 0 | |
| 114741442 | 11474144 | 2 | 200809 | 200810 | 0 | |
| 114741442 | 11474144 | 3 | 200810 | 0 |