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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127299252 | 12729925 | 2 | F | 2016 | 20160912 | 20160909 | 20160927 | EXP | US-SAOL THERAPEUTICS-2016SAO00576 | SAOL THERAPEUTICS | 56.02 | YR | M | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127299252 | 12729925 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 16.381 ?G, DAY | U | U | 20075 | 16.381 | UG | INJECTION | QD | ||||
| 127299252 | 12729925 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 127299252 | 12729925 | 3 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 131.05 ?G, DAY | U | 0 | 131.5 | UG | QD | ||||||
| 127299252 | 12729925 | 4 | SS | CLONIDINE. | CLONIDINE | 1 | U | 0 | |||||||||||
| 127299252 | 12729925 | 5 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 0.191 MG, DAY | U | 0 | .191 | MG | QD | ||||||
| 127299252 | 12729925 | 6 | SS | FENTANYL. | FENTANYL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127299252 | 12729925 | 1 | Pain |
| 127299252 | 12729925 | 2 | Post laminectomy syndrome |
| 127299252 | 12729925 | 3 | Pain |
| 127299252 | 12729925 | 4 | Post laminectomy syndrome |
| 127299252 | 12729925 | 5 | Pain |
| 127299252 | 12729925 | 6 | Post laminectomy syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127299252 | 12729925 | OT |
| 127299252 | 12729925 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127299252 | 12729925 | Arachnoiditis | |
| 127299252 | 12729925 | Drug withdrawal syndrome | |
| 127299252 | 12729925 | Intentional product use issue | |
| 127299252 | 12729925 | Malaise | |
| 127299252 | 12729925 | Mobility decreased | |
| 127299252 | 12729925 | Neuralgia | |
| 127299252 | 12729925 | 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 |