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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126355241 | 12635524 | 1 | I | 20150702 | 20151201 | 20160809 | 20160809 | EXP | US-SAOL THERAPEUTICS-2016SAO00346 | SAOL THERAPEUTICS | 45.62 | YR | M | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126355241 | 12635524 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 998 ?G, DAY | U | 20075 | 998 | UG | INJECTION | QD | |||||
| 126355241 | 12635524 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 500 ?G, DAY | U | 20075 | 500 | UG | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126355241 | 12635524 | 1 | Muscle spasticity |
| 126355241 | 12635524 | 2 | Spinal cord injury |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126355241 | 12635524 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126355241 | 12635524 | Device malfunction | |
| 126355241 | 12635524 | Drug withdrawal syndrome | |
| 126355241 | 12635524 | Erythema | |
| 126355241 | 12635524 | Feeling hot | |
| 126355241 | 12635524 | Flushing | |
| 126355241 | 12635524 | Impaired healing | |
| 126355241 | 12635524 | Therapeutic response decreased |
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 |
|---|---|---|---|---|---|---|
| 126355241 | 12635524 | 1 | 20151201 | 0 | ||
| 126355241 | 12635524 | 2 | 20151201 | 0 |