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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127428791 | 12742879 | 1 | I | 201608 | 20160830 | 20160914 | 20160914 | EXP | US-SAOL THERAPEUTICS-2016SAO00618 | SAOL THERAPEUTICS | 12.06 | YR | F | Y | 34.92000 | KG | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127428791 | 12742879 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 130 ?G, DAY | U | U | 20075 | 130 | UG | INJECTION | QD |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127428791 | 12742879 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127428791 | 12742879 | Cerebrospinal fluid leakage | |
| 127428791 | 12742879 | Nausea | |
| 127428791 | 12742879 | Systemic infection | |
| 127428791 | 12742879 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |