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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117795762 | 11779576 | 2 | F | 2008 | 20160706 | 20151125 | 20160713 | EXP | US-JAZZ-JPI-P-033199 | JAZZ | 0.00 | F | Y | 53.00000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117795762 | 11779576 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 117795762 | 11779576 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 117795762 | 11779576 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 117795762 | 11779576 | 4 | SS | PREGABALIN. | PREGABALIN | 1 | SINGLE | U | 0 | ||||||||||
| 117795762 | 11779576 | 5 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK UNKNOWN, SINGLE | U | 0 | ||||||||||
| 117795762 | 11779576 | 6 | C | Iron | IRON | 1 | U | 0 | |||||||||||
| 117795762 | 11779576 | 7 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Parenteral | UNK UNKNOWN, SINGLE | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117795762 | 11779576 | 1 | Narcolepsy |
| 117795762 | 11779576 | 4 | Fibromyalgia |
| 117795762 | 11779576 | 5 | Somnolence |
| 117795762 | 11779576 | 6 | Serum ferritin decreased |
| 117795762 | 11779576 | 7 | Vitamin B12 decreased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117795762 | 11779576 | HO |
| 117795762 | 11779576 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117795762 | 11779576 | Agitation | |
| 117795762 | 11779576 | Headache | |
| 117795762 | 11779576 | Hypoaesthesia | |
| 117795762 | 11779576 | Hysterectomy | |
| 117795762 | 11779576 | Intervertebral disc protrusion | |
| 117795762 | 11779576 | Irritability | |
| 117795762 | 11779576 | Nausea | |
| 117795762 | 11779576 | Uterine haemorrhage | |
| 117795762 | 11779576 | Weight decreased | |
| 117795762 | 11779576 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 117795762 | 11779576 | 1 | 20080327 | 200805 | 0 | |
| 117795762 | 11779576 | 2 | 200805 | 200809 | 0 | |
| 117795762 | 11779576 | 3 | 200810 | 0 |