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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126271011 | 12627101 | 1 | I | 20150630 | 20160803 | 20160805 | 20160805 | EXP | NO-NOMAADVRE-PASRAPP-2016-0002377 | NO-ALLERGAN-1664769US | ALLERGAN | 29.00 | YR | M | Y | 80.00000 | KG | 20160805 | CN | NO | NO |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126271011 | 12627101 | 1 | PS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | 25 UNITS, SINGLE | 103000 | POWDER FOR INJECTION | QD | ||||||||
126271011 | 12627101 | 2 | SS | BOTOX | ONABOTULINUMTOXINA | 1 | 103000 | POWDER FOR INJECTION |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126271011 | 12627101 | 1 | Drooling |
126271011 | 12627101 | 2 | Dysphagia |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126271011 | 12627101 | DE |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126271011 | 12627101 | Death | |
126271011 | 12627101 | Off label use |
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 |
---|---|---|---|---|---|---|
126271011 | 12627101 | 1 | 20150626 | 20150626 | 0 |