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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118533792 | 11853379 | 2 | F | 20160819 | 20151218 | 20160826 | EXP | US-JAZZ-2014-US-011249 | JAZZ | 0.00 | F | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118533792 | 11853379 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | U | 3078577 | 21196 | 1.5 | G | ORAL SOLUTION | |||||
| 118533792 | 11853379 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSAGE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 118533792 | 11853379 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, BID | U | 3113960 | 21196 | 2 | G | ORAL SOLUTION | |||||
| 118533792 | 11853379 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | U | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 118533792 | 11853379 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, SECOND DOSE | U | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
| 118533792 | 11853379 | 6 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118533792 | 11853379 | 1 | Narcolepsy |
| 118533792 | 11853379 | 6 | Narcolepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118533792 | 11853379 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118533792 | 11853379 | Accident | |
| 118533792 | 11853379 | Autoimmune disorder | |
| 118533792 | 11853379 | Bladder disorder | |
| 118533792 | 11853379 | Dysphonia | |
| 118533792 | 11853379 | Fibromyalgia | |
| 118533792 | 11853379 | Injury | |
| 118533792 | 11853379 | Intervertebral disc degeneration | |
| 118533792 | 11853379 | Multiple allergies | |
| 118533792 | 11853379 | Nasal injury | |
| 118533792 | 11853379 | Sinusitis | |
| 118533792 | 11853379 | Somnambulism | |
| 118533792 | 11853379 | Surgery | |
| 118533792 | 11853379 | VIIth nerve 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 |
|---|---|---|---|---|---|---|
| 118533792 | 11853379 | 1 | 201005 | 2010 | 0 | |
| 118533792 | 11853379 | 3 | 201307 | 0 | ||
| 118533792 | 11853379 | 4 | 201409 | 0 | ||
| 118533792 | 11853379 | 5 | 201409 | 0 |