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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126604271 | 12660427 | 1 | I | 20160203 | 20160802 | 20160817 | 20160817 | EXP | US-SAOL THERAPEUTICS-2016SAO00421 | SAOL THERAPEUTICS | 56.25 | YR | F | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126604271 | 12660427 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 99.92 ?G, DAY | U | U | 20075 | 99.92 | UG | INJECTION | QD | ||||
| 126604271 | 12660427 | 2 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 139.01 ?G, DAY | U | U | 20075 | 139.1 | UG | INJECTION | QD | ||||
| 126604271 | 12660427 | 3 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 99.92 ?G, DAY | U | 0 | 99.92 | UG | QD | ||||||
| 126604271 | 12660427 | 4 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 139.01 ?G, DAY | U | 0 | 139.1 | UG | QD | ||||||
| 126604271 | 12660427 | 5 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 1.998 MG, DAY | U | 0 | 1.998 | MG | QD | ||||||
| 126604271 | 12660427 | 6 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 2.780 MG, DAY | U | 0 | 2.78 | MG | QD | ||||||
| 126604271 | 12660427 | 7 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 5.995 MG, DAY | U | 0 | 5.995 | MG | QD | ||||||
| 126604271 | 12660427 | 8 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 8.341 MG, DAY | U | 0 | 8.341 | MG | QD |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126604271 | 12660427 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126604271 | 12660427 | Hypertension | |
| 126604271 | 12660427 | Respiratory distress |
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 |
|---|---|---|---|---|---|---|
| 126604271 | 12660427 | 1 | 20160203 | 0 | ||
| 126604271 | 12660427 | 2 | 20160203 | 0 | ||
| 126604271 | 12660427 | 3 | 20160203 | 0 | ||
| 126604271 | 12660427 | 4 | 20160203 | 0 | ||
| 126604271 | 12660427 | 5 | 20160203 | 0 | ||
| 126604271 | 12660427 | 6 | 20160203 | 0 | ||
| 126604271 | 12660427 | 7 | 20160203 | 0 | ||
| 126604271 | 12660427 | 8 | 20160203 | 0 |