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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126164791 | 12616479 | 1 | I | 20160510 | 20120717 | 20160802 | 20160802 | EXP | US-SAOL THERAPEUTICS-2016SAO00314 | SAOL THERAPEUTICS | 68.73 | YR | M | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126164791 | 12616479 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | U | U | 20075 | INJECTION | ||||||||
| 126164791 | 12616479 | 2 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 126164791 | 12616479 | 3 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | U | 0 | ||||||||||
| 126164791 | 12616479 | 4 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | U | 0 | ||||||||||
| 126164791 | 12616479 | 5 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126164791 | 12616479 | 1 | Pain |
| 126164791 | 12616479 | 2 | Post laminectomy syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126164791 | 12616479 | HO |
| 126164791 | 12616479 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126164791 | 12616479 | Device issue | |
| 126164791 | 12616479 | Drug withdrawal syndrome | |
| 126164791 | 12616479 | Hypoacusis | |
| 126164791 | 12616479 | Insomnia | |
| 126164791 | 12616479 | Mobility decreased | |
| 126164791 | 12616479 | Off label use | |
| 126164791 | 12616479 | Pain | |
| 126164791 | 12616479 | Restless legs syndrome | |
| 126164791 | 12616479 | Somnolence | |
| 126164791 | 12616479 | Therapy non-responder | |
| 126164791 | 12616479 | Unevaluable event |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |