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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124845692 | 12484569 | 2 | F | 20120824 | 20160802 | 20160621 | 20160809 | EXP | US-JAZZ-JPI-P-025631 | JAZZ | 35.21 | YR | F | Y | 61.00000 | KG | 20160809 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124845692 | 12484569 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124845692 | 12484569 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124845692 | 12484569 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.25 G, FIRST DOSE | U | 21196 | 4.25 | G | ORAL SOLUTION | ||||||
| 124845692 | 12484569 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, SECOND DOSE | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 124845692 | 12484569 | 5 | C | ARMODAFINIL. | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 124845692 | 12484569 | 6 | C | ESTRADIOL. | ESTRADIOL | 1 | 0.1 %, SINGLE | U | 0 | .1 | PCT | ||||||||
| 124845692 | 12484569 | 7 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Parenteral | UNK | U | 0 | |||||||||
| 124845692 | 12484569 | 8 | C | DIVIGEL | ESTRADIOL | 1 | 5 MG, SINGLE | U | 0 | 5 | MG | ||||||||
| 124845692 | 12484569 | 9 | C | Mixed amphetamine salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124845692 | 12484569 | 1 | Narcolepsy |
| 124845692 | 12484569 | 5 | Product used for unknown indication |
| 124845692 | 12484569 | 6 | Product used for unknown indication |
| 124845692 | 12484569 | 7 | Postoperative care |
| 124845692 | 12484569 | 8 | Narcolepsy |
| 124845692 | 12484569 | 9 | Narcolepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124845692 | 12484569 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124845692 | 12484569 | Cyst removal | |
| 124845692 | 12484569 | Ear infection | |
| 124845692 | 12484569 | Insomnia | |
| 124845692 | 12484569 | Muscle strain | |
| 124845692 | 12484569 | Oophorectomy | |
| 124845692 | 12484569 | Ovarian cyst | |
| 124845692 | 12484569 | Ovarian operation | |
| 124845692 | 12484569 | Ovarian remnant syndrome | |
| 124845692 | 12484569 | Pain | |
| 124845692 | 12484569 | Sciatica | |
| 124845692 | 12484569 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 124845692 | 12484569 | 1 | 20100113 | 201002 | 0 | |
| 124845692 | 12484569 | 2 | 201002 | 201306 | 0 | |
| 124845692 | 12484569 | 3 | 201306 | 0 | ||
| 124845692 | 12484569 | 4 | 201306 | 0 | ||
| 124845692 | 12484569 | 5 | 2010 | 0 | ||
| 124845692 | 12484569 | 6 | 201202 | 0 |