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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127779091 | 12777909 | 1 | I | 20160609 | 20160924 | 20160924 | PER | US-JAZZ-2016-US-010782 | JAZZ | 0.00 | F | Y | 0.00000 | 20160924 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127779091 | 12777909 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127779091 | 12777909 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127779091 | 12777909 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127779091 | 12777909 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127779091 | 12777909 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127779091 | 12777909 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127779091 | 12777909 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127779091 | 12777909 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | U | 0 | |||||||||||
| 127779091 | 12777909 | 9 | C | MOTRIN IB | IBUPROFEN | 1 | U | 0 | |||||||||||
| 127779091 | 12777909 | 10 | C | Methylphenidate sr | 2 | U | 0 | ||||||||||||
| 127779091 | 12777909 | 11 | C | QNASL | BECLOMETHASONE DIPROPIONATE | 1 | U | 0 | |||||||||||
| 127779091 | 12777909 | 12 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127779091 | 12777909 | 13 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127779091 | 12777909 | 14 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127779091 | 12777909 | 15 | C | ALEVE | NAPROXEN SODIUM | 1 | U | 0 | |||||||||||
| 127779091 | 12777909 | 16 | C | SEASONIQUE | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | U | 0 | |||||||||||
| 127779091 | 12777909 | 17 | C | WAL ITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 127779091 | 12777909 | 18 | C | Xanax prn | 2 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127779091 | 12777909 | 1 | Narcolepsy |
| 127779091 | 12777909 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127779091 | 12777909 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 127779091 | 12777909 | 1 | 200909 | 200910 | 0 | |
| 127779091 | 12777909 | 2 | 200910 | 200911 | 0 | |
| 127779091 | 12777909 | 3 | 200911 | 2013 | 0 | |
| 127779091 | 12777909 | 4 | 201402 | 2014 | 0 | |
| 127779091 | 12777909 | 5 | 201412 | 2015 | 0 | |
| 127779091 | 12777909 | 6 | 201506 | 201507 | 0 | |
| 127779091 | 12777909 | 7 | 201507 | 0 |