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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126556602 | 12655660 | 2 | F | 20160718 | 20160822 | 20160816 | 20160906 | EXP | US-SAOL THERAPEUTICS-2016SAO00385 | SAOL THERAPEUTICS | 73.82 | YR | F | Y | 85.26000 | KG | 20160906 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126556602 | 12655660 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 100 ?G, DAY | 20075 | 100 | UG | INJECTION | QD | ||||||
126556602 | 12655660 | 2 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | 20075 | INJECTION | |||||||||||
126556602 | 12655660 | 3 | SS | MORPHINE | MORPHINE | 1 | 1.5 MG, DAY | 0 | 1.5 | MG | QD | ||||||||
126556602 | 12655660 | 4 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 1.8 MG, DAY | 0 | 1.8 | MG | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126556602 | 12655660 | 1 | Pain |
126556602 | 12655660 | 2 | Muscle spasms |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126556602 | 12655660 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126556602 | 12655660 | Cellulitis | |
126556602 | 12655660 | Off label use | |
126556602 | 12655660 | Rash |
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 |
---|---|---|---|---|---|---|
126556602 | 12655660 | 1 | 20151028 | 0 |