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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287111 | 12528711 | 1 | I | 20160420 | 20160419 | 20160705 | 20160705 | EXP | US-SAOL THERAPEUTICS-2016SAO00011 | SAOL THERAPEUTICS | 61.76 | YR | M | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287111 | 12528711 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 450 ?G, DAY | 300 | UG | U | U | 20075 | 450 | UG | QD | |||
| 125287111 | 12528711 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 150 ?G, DAY | 300 | UG | U | U | 20075 | 150 | UG | QD | |||
| 125287111 | 12528711 | 3 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 100 ?G, DAY | 300 | UG | U | U | 20075 | 100 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125287111 | 12528711 | 1 | Muscle spasticity |
| 125287111 | 12528711 | 2 | Cerebrovascular accident |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125287111 | 12528711 | OT |
| 125287111 | 12528711 | HO |
| 125287111 | 12528711 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125287111 | 12528711 | Abasia | |
| 125287111 | 12528711 | Drug hypersensitivity | |
| 125287111 | 12528711 | Infection | |
| 125287111 | 12528711 | Somnolence | |
| 125287111 | 12528711 | Therapy non-responder | |
| 125287111 | 12528711 | Weight bearing difficulty |
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 |
|---|---|---|---|---|---|---|
| 125287111 | 12528711 | 2 | 20160419 | 20160420 | 0 | |
| 125287111 | 12528711 | 3 | 20160421 | 0 |