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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127867091 | 12786709 | 1 | I | 20160516 | 20160927 | 20160927 | EXP | US-SAOL THERAPEUTICS-2016SAO00708 | SAOL THERAPEUTICS | 0.00 | F | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127867091 | 12786709 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 250 ?G, DAY | U | U | 20075 | 250 | UG | INJECTION | QD | ||||
| 127867091 | 12786709 | 2 | SS | LIORESAL | BACLOFEN | 1 | 100 ?GDAY | U | U | 20075 | 100 | UG | INJECTION | QD | |||||
| 127867091 | 12786709 | 3 | SS | BACLOFEN. | BACLOFEN | 1 | Oral | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127867091 | 12786709 | 1 | Muscle spasticity |
| 127867091 | 12786709 | 2 | Cerebrovascular accident |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127867091 | 12786709 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127867091 | 12786709 | Drug withdrawal syndrome | |
| 127867091 | 12786709 | Immunisation reaction | |
| 127867091 | 12786709 | Irritability |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |