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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124845372 | 12484537 | 2 | F | 201512 | 20160627 | 20160621 | 20160701 | EXP | US-JAZZ-2016-US-010984 | JAZZ | 28.09 | YR | F | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124845372 | 12484537 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 124845372 | 12484537 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 124845372 | 12484537 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124845372 | 12484537 | 4 | C | CELEBREX | CELECOXIB | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124845372 | 12484537 | 5 | C | DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONEETHINYL ESTRADIOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124845372 | 12484537 | 6 | C | DAYTRANA | METHYLPHENIDATE | 1 | 30 MG/9 HOUR | U | 0 | PATCH | |||||||||
| 124845372 | 12484537 | 7 | C | Omega 3 fish oil | FISH OILOMEGA-3 FATTY ACIDS | 1 | UNK | U | 0 | ||||||||||
| 124845372 | 12484537 | 8 | C | Mvi | VITAMINS | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124845372 | 12484537 | 1 | Hypersomnia |
| 124845372 | 12484537 | 4 | Product used for unknown indication |
| 124845372 | 12484537 | 5 | Product used for unknown indication |
| 124845372 | 12484537 | 6 | Product used for unknown indication |
| 124845372 | 12484537 | 7 | Product used for unknown indication |
| 124845372 | 12484537 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124845372 | 12484537 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124845372 | 12484537 | Pre-existing condition improved | |
| 124845372 | 12484537 | Rheumatoid arthritis | |
| 124845372 | 12484537 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 124845372 | 12484537 | 1 | 200903 | 2009 | 0 | |
| 124845372 | 12484537 | 2 | 200905 | 2010 | 0 | |
| 124845372 | 12484537 | 3 | 201010 | 0 | ||
| 124845372 | 12484537 | 4 | 20160401 | 0 | ||
| 124845372 | 12484537 | 5 | 201401 | 0 | ||
| 124845372 | 12484537 | 6 | 200909 | 0 | ||
| 124845372 | 12484537 | 7 | 200903 | 0 |