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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124904592 | 12490459 | 2 | F | 201605 | 20160705 | 20160622 | 20160713 | EXP | US-JAZZ-2016-US-009982 | JAZZ | 37.40 | YR | F | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124904592 | 12490459 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 124904592 | 12490459 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 124904592 | 12490459 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 124904592 | 12490459 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.25 G, SECOND DOSE | 21196 | 4.25 | G | ORAL SOLUTION | |||||||
| 124904592 | 12490459 | 5 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 6 | C | Xyralid | 2 | 3-0.5, 4.5 EXTERNAL | U | 0 | |||||||||||
| 124904592 | 12490459 | 7 | C | Xyralid | 2 | UNK | U | 0 | |||||||||||
| 124904592 | 12490459 | 8 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124904592 | 12490459 | 9 | C | ATIVAN | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 10 | C | BUPRENORPHINE. | BUPRENORPHINE | 1 | 2 MG | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 11 | C | BUPRENORPHINE. | BUPRENORPHINE | 1 | 8 MG | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 12 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124904592 | 12490459 | 13 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124904592 | 12490459 | 14 | C | QUASENSE | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 15 | C | QUASENSE | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 16 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 17 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 18 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 19 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 20 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124904592 | 12490459 | 21 | C | MINASTRIN 24 FE | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | UNK | U | 0 | CHEWABLE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124904592 | 12490459 | 1 | Hypersomnia |
| 124904592 | 12490459 | 5 | Product used for unknown indication |
| 124904592 | 12490459 | 6 | Product used for unknown indication |
| 124904592 | 12490459 | 8 | Product used for unknown indication |
| 124904592 | 12490459 | 9 | Product used for unknown indication |
| 124904592 | 12490459 | 10 | Product used for unknown indication |
| 124904592 | 12490459 | 12 | Product used for unknown indication |
| 124904592 | 12490459 | 14 | Product used for unknown indication |
| 124904592 | 12490459 | 16 | Product used for unknown indication |
| 124904592 | 12490459 | 18 | Product used for unknown indication |
| 124904592 | 12490459 | 19 | Product used for unknown indication |
| 124904592 | 12490459 | 20 | Product used for unknown indication |
| 124904592 | 12490459 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124904592 | 12490459 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124904592 | 12490459 | Face injury | |
| 124904592 | 12490459 | Insomnia | |
| 124904592 | 12490459 | Loss of consciousness | |
| 124904592 | 12490459 | Musculoskeletal discomfort | |
| 124904592 | 12490459 | Restless legs syndrome |
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 |
|---|---|---|---|---|---|---|
| 124904592 | 12490459 | 1 | 201403 | 201403 | 0 | |
| 124904592 | 12490459 | 3 | 201504 | 0 | ||
| 124904592 | 12490459 | 4 | 201504 | 0 | ||
| 124904592 | 12490459 | 5 | 20160114 | 20160119 | 0 | |
| 124904592 | 12490459 | 6 | 20151014 | 20151014 | 0 | |
| 124904592 | 12490459 | 7 | 20160114 | 20160119 | 0 | |
| 124904592 | 12490459 | 8 | 20151014 | 0 | ||
| 124904592 | 12490459 | 9 | 20151014 | 20151014 | 0 | |
| 124904592 | 12490459 | 10 | 20151014 | 20160520 | 0 | |
| 124904592 | 12490459 | 11 | 20140314 | 20151014 | 0 | |
| 124904592 | 12490459 | 12 | 20140314 | 20151014 | 0 | |
| 124904592 | 12490459 | 13 | 20151014 | 0 | ||
| 124904592 | 12490459 | 14 | 20140314 | 20151014 | 0 | |
| 124904592 | 12490459 | 15 | 20151014 | 201603 | 0 | |
| 124904592 | 12490459 | 16 | 20140314 | 20151014 | 0 | |
| 124904592 | 12490459 | 17 | 20151014 | 0 | ||
| 124904592 | 12490459 | 18 | 20140314 | 20151014 | 0 | |
| 124904592 | 12490459 | 19 | 201606 | 201606 | 0 | |
| 124904592 | 12490459 | 20 | 201606 | 201606 | 0 | |
| 124904592 | 12490459 | 21 | 201604 | 0 |