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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125229151 | 12522915 | 1 | I | 2016 | 20160617 | 20160701 | 20160701 | EXP | US-SAOL THERAPEUTICS-2016SAO00019 | SAOL THERAPEUTICS | 0.00 | F | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125229151 | 12522915 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 107.45 ?G, DAILY | 20075 | 107.45 | UG | INJECTION | |||||||
| 125229151 | 12522915 | 2 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | 6.14 MG, DAILY | 0 | 6.14 | MG | |||||||||
| 125229151 | 12522915 | 3 | SS | CLONIDINE. | CLONIDINE | 1 | 153.50 ?G, DAILY | 0 | 153.5 | UG | |||||||||
| 125229151 | 12522915 | 4 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 4.605 TO 3 MG, DAILY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125229151 | 12522915 | 1 | Pain |
| 125229151 | 12522915 | 2 | Pain |
| 125229151 | 12522915 | 3 | Pain |
| 125229151 | 12522915 | 4 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125229151 | 12522915 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125229151 | 12522915 | Medical device site pain | |
| 125229151 | 12522915 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |