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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127299241 | 12729924 | 1 | I | 20160420 | 20160909 | 20160909 | EXP | US-SAOL THERAPEUTICS-2016SAO00301 | SAOL THERAPEUTICS | 0.00 | M | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127299241 | 12729924 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 149.82 ?G, DAY | Y | U | 20075 | 149.82 | UG | INJECTION | QD | ||||
| 127299241 | 12729924 | 2 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 125.01 ?G, DAY | U | 20075 | 125.1 | UG | INJECTION | QD | |||||
| 127299241 | 12729924 | 3 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 74.912 ?G, DAY | Y | 0 | 74.914 | UG | QD | ||||||
| 127299241 | 12729924 | 4 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 62.51 ?G, DAY | U | 0 | 62.51 | UG | QD | ||||||
| 127299241 | 12729924 | 5 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 8.0905 MG, DAY | Y | 0 | 8.9 | MG | QD | ||||||
| 127299241 | 12729924 | 6 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 7.501 MG, DAY | U | 0 | 7.501 | MG | QD | ||||||
| 127299241 | 12729924 | 7 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 1.4982 MG, DAY | Y | 0 | 1.498 | MG | QD | ||||||
| 127299241 | 12729924 | 8 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 1.2501 MG, DAY | U | 0 | 1.25 | MG | QD | ||||||
| 127299241 | 12729924 | 9 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | UNKNOWN | 0 | |||||||||||
| 127299241 | 12729924 | 10 | C | OXYDODONE | OXYCODONE | 1 | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127299241 | 12729924 | 1 | Pain |
| 127299241 | 12729924 | 2 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127299241 | 12729924 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127299241 | 12729924 | Implant site extravasation | |
| 127299241 | 12729924 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127299241 | 12729924 | 1 | 20160309 | 20160316 | 0 | |
| 127299241 | 12729924 | 2 | 20160316 | 0 | ||
| 127299241 | 12729924 | 3 | 20160309 | 20160316 | 0 | |
| 127299241 | 12729924 | 4 | 20160316 | 0 | ||
| 127299241 | 12729924 | 5 | 20160309 | 20160316 | 0 | |
| 127299241 | 12729924 | 6 | 20160316 | 0 | ||
| 127299241 | 12729924 | 7 | 20160309 | 20160316 | 0 | |
| 127299241 | 12729924 | 8 | 20160316 | 0 |