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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127077972 | 12707797 | 2 | F | 20151210 | 20160908 | 20160901 | 20160922 | EXP | US-SAOL THERAPEUTICS-2016SAO00507 | SAOL THERAPEUTICS | 54.37 | YR | F | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127077972 | 12707797 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 828.3 ?G, DAY | U | U | N642246 | 20075 | 828.3 | UG | INJECTION | QD | |||
| 127077972 | 12707797 | 2 | SS | LIORESAL | BACLOFEN | 1 | 970 ?G, DAY | U | U | 20075 | 970 | UG | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127077972 | 12707797 | 1 | Muscle spasticity |
| 127077972 | 12707797 | 2 | Spinal cord injury |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127077972 | 12707797 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127077972 | 12707797 | Cerebrospinal fluid leakage | |
| 127077972 | 12707797 | Device infusion issue | |
| 127077972 | 12707797 | Drug withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 127077972 | 12707797 | 1 | 20160817 | 0 | ||
| 127077972 | 12707797 | 2 | 20160908 | 0 |