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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127000081 | 12700008 | 1 | I | 20160809 | 20160830 | 20160830 | EXP | US-SAOL THERAPEUTICS-2016SAO00519 | SAOL THERAPEUTICS | 0.00 | F | Y | 0.00000 | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127000081 | 12700008 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 28.62 ?G, DAY | U | U | 20075 | 28.62 | UG | INJECTION | QD | ||||
| 127000081 | 12700008 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 127000081 | 12700008 | 3 | SS | BACLOFEN. | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 127000081 | 12700008 | 4 | SS | BACLOFEN. | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 127000081 | 12700008 | 5 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 28.62 ?G, DAY | U | 0 | 28.62 | UG | QD | ||||||
| 127000081 | 12700008 | 6 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 400 ?G, DAY | U | 0 | 400 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127000081 | 12700008 | 1 | Back pain |
| 127000081 | 12700008 | 2 | Pain |
| 127000081 | 12700008 | 3 | Parkinson's disease |
| 127000081 | 12700008 | 4 | Movement disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127000081 | 12700008 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127000081 | 12700008 | Hospice care | |
| 127000081 | 12700008 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |