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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126230311 | 12623031 | 1 | I | 20160720 | 20160720 | 20160804 | 20160804 | EXP | US-SAOL THERAPEUTICS-2016SAO00318 | SAOL THERAPEUTICS | 68.19 | YR | M | Y | 110.66000 | KG | 20160804 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126230311 | 12623031 | 1 | PS | LIORESAL | BACLOFEN | 1 | 149.79 ?G, DAY | Y | U | 20075 | 149.79 | UG | INJECTION | QD | |||||
| 126230311 | 12623031 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 135.07 ?G, DAY | Y | U | 20075 | 135.7 | UG | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126230311 | 12623031 | 1 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126230311 | 12623031 | OT |
| 126230311 | 12623031 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126230311 | 12623031 | Cerebral disorder | |
| 126230311 | 12623031 | Device failure | |
| 126230311 | 12623031 | Hemiparesis | |
| 126230311 | 12623031 | Pyrexia | |
| 126230311 | 12623031 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 126230311 | 12623031 | 1 | 20160720 | 0 | ||
| 126230311 | 12623031 | 2 | 20160720 | 0 |