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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126199202 | 12619920 | 2 | F | 2016 | 20160812 | 20160803 | 20160826 | EXP | US-SAOL THERAPEUTICS-2016SAO00302 | SAOL THERAPEUTICS | 44.50 | YR | F | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126199202 | 12619920 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | 297.39 ?G, DAY | U | U | 20075 | 297.39 | UG | INJECTION | QD | |||||
| 126199202 | 12619920 | 2 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | 299.83 ?G, DAY | U | U | 20075 | 299.83 | UG | INJECTION | QD | |||||
| 126199202 | 12619920 | 3 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 315.14 ?G, DAY | U | U | 20075 | 315.14 | UG | INJECTION | QD | ||||
| 126199202 | 12619920 | 4 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 420.2 ?G, DAY | U | U | 20075 | 420.2 | UG | INJECTION | QD | ||||
| 126199202 | 12619920 | 5 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 126199202 | 12619920 | 6 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 5.948 MG, DAY | 0 | 5.948 | MG | QD | |||||||
| 126199202 | 12619920 | 7 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 5.997 MG, DAY | 0 | 5.997 | MG | QD | |||||||
| 126199202 | 12619920 | 8 | SS | MORPHINE | MORPHINE | 1 | 6.303 MG, DAY | 0 | 6.303 | MG | QD | ||||||||
| 126199202 | 12619920 | 9 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 7.930 MG, DAY | 0 | 7.93 | MG | QD | |||||||
| 126199202 | 12619920 | 10 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | 7.995 ?G, DAY | 0 | 7.995 | UG | QD | ||||||||
| 126199202 | 12619920 | 11 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | 8.404 ?G, DAY | 0 | 8.404 | UG | QD | ||||||||
| 126199202 | 12619920 | 12 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 8.404 MG, DAY | 0 | 8.404 | MG | QD | |||||||
| 126199202 | 12619920 | 13 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 39.65 ?G, DAY | 0 | 39.65 | UG | QD | |||||||
| 126199202 | 12619920 | 14 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 39.98 ?G, DAY | 0 | 39.98 | UG | QD | |||||||
| 126199202 | 12619920 | 15 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 42.02 ?G, DAY | 0 | 42.2 | UG | QD | |||||||
| 126199202 | 12619920 | 16 | SS | CLONIDINE. | CLONIDINE | 1 | 42.02 ?G, DAY | 0 | 42.2 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126199202 | 12619920 | 1 | Lumbar radiculopathy |
| 126199202 | 12619920 | 2 | Pain |
| 126199202 | 12619920 | 4 | Lumbar radiculopathy |
| 126199202 | 12619920 | 5 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126199202 | 12619920 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126199202 | 12619920 | Device dislocation | |
| 126199202 | 12619920 | Drug withdrawal syndrome | |
| 126199202 | 12619920 | Hypoaesthesia | |
| 126199202 | 12619920 | Impaired healing | |
| 126199202 | 12619920 | Medical device site discharge | |
| 126199202 | 12619920 | Medical device site erythema | |
| 126199202 | 12619920 | Medical device site infection | |
| 126199202 | 12619920 | Medical device site pain | |
| 126199202 | 12619920 | Medical device site vesicles |
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 |
|---|---|---|---|---|---|---|
| 126199202 | 12619920 | 1 | 20150924 | 0 | ||
| 126199202 | 12619920 | 2 | 20160120 | 0 | ||
| 126199202 | 12619920 | 3 | 20160218 | 0 | ||
| 126199202 | 12619920 | 4 | 20160414 | 0 | ||
| 126199202 | 12619920 | 6 | 20150924 | 0 | ||
| 126199202 | 12619920 | 7 | 20160120 | 0 | ||
| 126199202 | 12619920 | 8 | 20160218 | 0 | ||
| 126199202 | 12619920 | 9 | 20150924 | 0 | ||
| 126199202 | 12619920 | 10 | 20160120 | 0 | ||
| 126199202 | 12619920 | 11 | 20160218 | 0 | ||
| 126199202 | 12619920 | 12 | 20160414 | 0 | ||
| 126199202 | 12619920 | 13 | 20150924 | 0 | ||
| 126199202 | 12619920 | 14 | 20160120 | 20150924 | 0 | |
| 126199202 | 12619920 | 15 | 20160218 | 0 | ||
| 126199202 | 12619920 | 16 | 20160414 | 0 |