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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117484843 | 11748484 | 3 | F | 2015 | 20160915 | 20151117 | 20160923 | EXP | US-JAZZ-2015-US-019173 | JAZZ | 0.00 | F | Y | 113.38000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117484843 | 11748484 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 117484843 | 11748484 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 117484843 | 11748484 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117484843 | 11748484 | 1 | Fibromyalgia |
| 117484843 | 11748484 | 2 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117484843 | 11748484 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117484843 | 11748484 | Arthritis | |
| 117484843 | 11748484 | Colitis | |
| 117484843 | 11748484 | Contusion | |
| 117484843 | 11748484 | Cystitis | |
| 117484843 | 11748484 | Fall | |
| 117484843 | 11748484 | Gastritis | |
| 117484843 | 11748484 | Gastrointestinal disorder | |
| 117484843 | 11748484 | Intentional product use issue | |
| 117484843 | 11748484 | Osteopenia | |
| 117484843 | 11748484 | Osteoporosis | |
| 117484843 | 11748484 | Sleep apnoea syndrome | |
| 117484843 | 11748484 | Tinnitus | |
| 117484843 | 11748484 | Ulcer | |
| 117484843 | 11748484 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 117484843 | 11748484 | 1 | 200505 | 2005 | 0 | |
| 117484843 | 11748484 | 2 | 200505 | 2005 | 0 | |
| 117484843 | 11748484 | 3 | 2008 | 0 |