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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125321362 | 12532136 | 2 | F | 20160621 | 20160707 | 20160706 | 20160722 | EXP | US-SAOL THERAPEUTICS-2016SAO00087 | SAOL THERAPEUTICS | 0.00 | F | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125321362 | 12532136 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | UNK | U | U | UNKNOWN | 20075 | INJECTION | ||||||
| 125321362 | 12532136 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 125321362 | 12532136 | 3 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | U | U | 0 | |||||||||
| 125321362 | 12532136 | 4 | SS | MORPHINE | MORPHINE | 1 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125321362 | 12532136 | 1 | Pain |
| 125321362 | 12532136 | 2 | Neuropathy peripheral |
| 125321362 | 12532136 | 3 | Pain |
| 125321362 | 12532136 | 4 | Neuropathy peripheral |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125321362 | 12532136 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125321362 | 12532136 | Device end of service | |
| 125321362 | 12532136 | Muscle spasticity | |
| 125321362 | 12532136 | Pain |
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 |
|---|---|---|---|---|---|---|
| 125321362 | 12532136 | 1 | 201606 | 0 |