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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126493161 | 12649316 | 1 | I | 2012 | 20120718 | 20160812 | 20160812 | EXP | US-JAZZ-JPI-P-022860 | JAZZ | 0.00 | F | Y | 0.00000 | 20160812 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126493161 | 12649316 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
126493161 | 12649316 | 2 | SS | METOPROLOL. | METOPROLOL | 1 | UNK | 0 | |||||||||||
126493161 | 12649316 | 3 | C | Amphetamine mixed salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 10 MG, BID | U | 0 | 10 | MG | ||||||||
126493161 | 12649316 | 4 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | U | 0 | ||||||||||
126493161 | 12649316 | 5 | C | BOTOX | ONABOTULINUMTOXINA | 1 | UNK | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126493161 | 12649316 | 1 | Insomnia |
126493161 | 12649316 | 2 | Product used for unknown indication |
126493161 | 12649316 | 3 | Product used for unknown indication |
126493161 | 12649316 | 4 | Product used for unknown indication |
126493161 | 12649316 | 5 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126493161 | 12649316 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126493161 | 12649316 | Fatigue | |
126493161 | 12649316 | Ventricular tachycardia |
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 |
---|---|---|---|---|---|---|
126493161 | 12649316 | 1 | 20111108 | 0 |