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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126420681 | 12642068 | 1 | I | 2010 | 20110510 | 20160810 | 20160810 | EXP | US-SAOL THERAPEUTICS-2016SAO00376 | SAOL THERAPEUTICS | 0.00 | M | Y | 0.00000 | 20160810 | CN | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126420681 | 12642068 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 1200 ?G, DAY | U | U | 20075 | 1200 | UG | INJECTION | QD | ||||
| 126420681 | 12642068 | 2 | SS | LIORESAL | BACLOFEN | 1 | U | U | 20075 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126420681 | 12642068 | 1 | Muscle spasticity |
| 126420681 | 12642068 | 2 | Spinal cord injury |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126420681 | 12642068 | OT |
| 126420681 | 12642068 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126420681 | 12642068 | Device failure | |
| 126420681 | 12642068 | Drug withdrawal syndrome | |
| 126420681 | 12642068 | Hospitalisation | |
| 126420681 | 12642068 | Implant site extravasation | |
| 126420681 | 12642068 | Implant site scar | |
| 126420681 | 12642068 | Muscle spasticity | |
| 126420681 | 12642068 | Therapeutic response decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |