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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127017051 | 12701705 | 1 | I | 20160417 | 20160831 | 20160831 | PER | US-JAZZ-2016-US-007280 | JAZZ | 0.00 | F | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127017051 | 12701705 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
| 127017051 | 12701705 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127017051 | 12701705 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127017051 | 12701705 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127017051 | 12701705 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127017051 | 12701705 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127017051 | 12701705 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127017051 | 12701705 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENT | 21196 | ORAL SOLUTION | |||||||||
| 127017051 | 12701705 | 9 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127017051 | 12701705 | 10 | SS | TAMIFLU | OSELTAMIVIR PHOSPHATE | 1 | 0 | ||||||||||||
| 127017051 | 12701705 | 11 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 127017051 | 12701705 | 12 | C | LOESTRIN NOS | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | U | 0 | |||||||||||
| 127017051 | 12701705 | 13 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127017051 | 12701705 | 1 | Narcolepsy |
| 127017051 | 12701705 | 2 | Cataplexy |
| 127017051 | 12701705 | 10 | Influenza like illness |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127017051 | 12701705 | Fatigue | |
| 127017051 | 12701705 | Influenza like illness |
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 |
|---|---|---|---|---|---|---|
| 127017051 | 12701705 | 1 | 200411 | 200411 | 0 | |
| 127017051 | 12701705 | 3 | 200501 | 2005 | 0 | |
| 127017051 | 12701705 | 4 | 200704 | 200705 | 0 | |
| 127017051 | 12701705 | 5 | 200705 | 200706 | 0 | |
| 127017051 | 12701705 | 6 | 200706 | 2007 | 0 | |
| 127017051 | 12701705 | 7 | 200904 | 200906 | 0 | |
| 127017051 | 12701705 | 9 | 201505 | 0 |