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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126911431 | 12691143 | 1 | I | 20160729 | 20160730 | 20160826 | 20160826 | EXP | US-SAOL THERAPEUTICS-2016SAO00486 | SAOL THERAPEUTICS | 45.62 | YR | F | Y | 0.00000 | 20160826 | OT | US | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126911431 | 12691143 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 29.98 ?G, DAY | U | U | 20075 | 29.98 | UG | INJECTION | QD | ||||
126911431 | 12691143 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
126911431 | 12691143 | 3 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 599.6 ?G, DAY | U | 0 | 599.6 | UG | QD | ||||||
126911431 | 12691143 | 4 | SS | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | Intrathecal | 2.998 MG, DAY | U | 0 | 2.998 | MG | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126911431 | 12691143 | 1 | Pain |
126911431 | 12691143 | 2 | Post laminectomy syndrome |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126911431 | 12691143 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126911431 | 12691143 | Device battery issue | |
126911431 | 12691143 | Device failure | |
126911431 | 12691143 | Off label use | |
126911431 | 12691143 | Unresponsive to stimuli |
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 |
---|---|---|---|---|---|---|
126911431 | 12691143 | 1 | 20160810 | 0 | ||
126911431 | 12691143 | 3 | 20160810 | 0 | ||
126911431 | 12691143 | 4 | 20160810 | 0 |