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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126081942 | 12608194 | 2 | F | 20160813 | 20160729 | 20160826 | EXP | US-SAOL THERAPEUTICS-2016SAO00284 | SAOL THERAPEUTICS | 0.00 | M | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126081942 | 12608194 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 178.72 ?G, DAY | U | U | 20075 | 178.72 | UG | INJECTION | QD | ||||
| 126081942 | 12608194 | 2 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 272.17 ?G, DAY | U | 0 | 272.17 | UG | INJECTION | QD | |||||
| 126081942 | 12608194 | 3 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 18.387 MG, DAY | 0 | 18.387 | MG | QD | |||||||
| 126081942 | 12608194 | 4 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 13.989 MG, DAY | U | 0 | 13.989 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126081942 | 12608194 | 1 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126081942 | 12608194 | HO |
| 126081942 | 12608194 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126081942 | 12608194 | Fall | |
| 126081942 | 12608194 | Hypoventilation | |
| 126081942 | 12608194 | Off label use | |
| 126081942 | 12608194 | Rib fracture | |
| 126081942 | 12608194 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126081942 | 12608194 | 2 | 20160824 | 0 | ||
| 126081942 | 12608194 | 4 | 20160824 | 0 |