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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128003451 | 12800345 | 1 | I | 20160524 | 20160525 | 20160930 | 20160930 | EXP | US-SAOL THERAPEUTICS-2016SAO00739 | SAOL THERAPEUTICS | 47.16 | YR | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128003451 | 12800345 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 34.49 ?G, DAY | U | U | 20075 | 34.49 | UG | INJECTION | QD | ||||
| 128003451 | 12800345 | 2 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 128003451 | 12800345 | 3 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 3448.9 ?G, DAY | U | 0 | 3448.9 | UG | QD | ||||||
| 128003451 | 12800345 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 | ||||||||||||
| 128003451 | 12800345 | 5 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 128003451 | 12800345 | 6 | C | NUCYNTA | TAPENTADOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 128003451 | 12800345 | 7 | C | CELEBREX | CELECOXIB | 1 | 0 | ||||||||||||
| 128003451 | 12800345 | 8 | C | XANAX | ALPRAZOLAM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 128003451 | 12800345 | 1 | Pain |
| 128003451 | 12800345 | 2 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 128003451 | 12800345 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 128003451 | 12800345 | Device failure | |
| 128003451 | 12800345 | Influenza like illness | |
| 128003451 | 12800345 | 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 |