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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126491132 | 12649113 | 2 | F | 201508 | 20160909 | 20160812 | 20160923 | EXP | US-SAOL THERAPEUTICS-2016SAO00371 | SAOL THERAPEUTICS | 68.79 | YR | F | Y | 97.30000 | KG | 20160923 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126491132 | 12649113 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 5.137 ?G, DAY | U | U | 20075 | 5.137 | UG | INJECTION | QD | ||||
| 126491132 | 12649113 | 2 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 126491132 | 12649113 | 3 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 924.7 ?G, DAY | U | 0 | 924.7 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126491132 | 12649113 | 1 | Pain |
| 126491132 | 12649113 | 2 | Back pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126491132 | 12649113 | OT |
| 126491132 | 12649113 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126491132 | 12649113 | Corynebacterium infection | |
| 126491132 | 12649113 | Deep vein thrombosis | |
| 126491132 | 12649113 | Implant site infection | |
| 126491132 | 12649113 | Off label use | |
| 126491132 | 12649113 | Skin lesion | |
| 126491132 | 12649113 | Spinal operation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |