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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125240021 | 12524002 | 1 | I | 2015 | 20151221 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022233 | JAZZ | 0.00 | F | Y | 0.00000 | 20160704 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125240021 | 12524002 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
125240021 | 12524002 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
125240021 | 12524002 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
125240021 | 12524002 | 4 | C | NABUMETONE. | NABUMETONE | 1 | UNK | U | 0 | TABLET | |||||||||
125240021 | 12524002 | 5 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
125240021 | 12524002 | 6 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
125240021 | 12524002 | 7 | C | MICROGESTIN FE | ETHINYL ESTRADIOLFERROUS FUMARATENORETHINDRONE ACETATE | 1 | UNK | U | 0 | TABLET | |||||||||
125240021 | 12524002 | 8 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
125240021 | 12524002 | 9 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125240021 | 12524002 | 1 | Narcolepsy |
125240021 | 12524002 | 2 | Cataplexy |
125240021 | 12524002 | 4 | Product used for unknown indication |
125240021 | 12524002 | 5 | Product used for unknown indication |
125240021 | 12524002 | 6 | Product used for unknown indication |
125240021 | 12524002 | 7 | Product used for unknown indication |
125240021 | 12524002 | 8 | Product used for unknown indication |
125240021 | 12524002 | 9 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125240021 | 12524002 | Clumsiness | |
125240021 | 12524002 | Fall | |
125240021 | 12524002 | Laceration | |
125240021 | 12524002 | Ligament sprain | |
125240021 | 12524002 | Muscle strain |
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 |
---|---|---|---|---|---|---|
125240021 | 12524002 | 1 | 201404 | 2014 | 0 | |
125240021 | 12524002 | 2 | 2014 | 2014 | 0 | |
125240021 | 12524002 | 3 | 2014 | 0 | ||
125240021 | 12524002 | 4 | 20141009 | 0 | ||
125240021 | 12524002 | 5 | 20140429 | 0 | ||
125240021 | 12524002 | 6 | 20131101 | 0 | ||
125240021 | 12524002 | 7 | 20131101 | 0 | ||
125240021 | 12524002 | 8 | 20130401 | 0 | ||
125240021 | 12524002 | 9 | 20070401 | 0 |