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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125574741 | 12557474 | 1 | I | 20160525 | 20160526 | 20160714 | 20160714 | EXP | US-SAOL THERAPEUTICS-2016SAO00146 | SAOL THERAPEUTICS | 48.85 | YR | F | Y | 0.00000 | 20160714 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125574741 | 12557474 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 375.7 ?G, DAY | U | U | 20075 | 375.7 | UG | INJECTION | QD | ||||
125574741 | 12557474 | 2 | C | GABAPENTIN. | GABAPENTIN | 1 | U | U | 0 | ||||||||||
125574741 | 12557474 | 3 | C | TRAMADOL. | TRAMADOL | 1 | 0 |
Indications of drugs used
no results found |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125574741 | 12557474 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125574741 | 12557474 | Hyperreflexia | |
125574741 | 12557474 | Muscle rigidity | |
125574741 | 12557474 | Muscle spasticity | |
125574741 | 12557474 | Tremor | |
125574741 | 12557474 | Underdose |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |