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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126081951 | 12608195 | 1 | I | 201604 | 20160525 | 20160729 | 20160729 | EXP | US-SAOL THERAPEUTICS-2016SAO00062 | SAOL THERAPEUTICS | 55.00 | YR | Y | 0.00000 | 20160729 | CN | US | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126081951 | 12608195 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 190.2 ?G, DAY | U | U | UNKNOWN | 20075 | 190.2 | UG | QD | ||||
| 126081951 | 12608195 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 158 ?G, DAY | U | U | UNKNOWN | 20075 | 158 | UG | QD | ||||
| 126081951 | 12608195 | 3 | SS | BACLOFEN. | BACLOFEN | 1 | Oral | U | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126081951 | 12608195 | OT |
| 126081951 | 12608195 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126081951 | 12608195 | Device damage | |
| 126081951 | 12608195 | Muscle spasticity | |
| 126081951 | 12608195 | Therapy non-responder | |
| 126081951 | 12608195 | Urinary tract infection | |
| 126081951 | 12608195 | Wound |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |