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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126811762 | 12681176 | 2 | F | 20160914 | 20160824 | 20160928 | EXP | US-SAOL THERAPEUTICS-2016SAO00449 | SAOL THERAPEUTICS | 0.00 | F | Y | 0.00000 | 20160928 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126811762 | 12681176 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 519.3 ?G, DAY | U | U | 20075 | 519.3 | UG | INJECTION | QD | ||||
| 126811762 | 12681176 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 5.9 ?G, DAY | U | U | 20075 | 5.9 | UG | INJECTION | QD | ||||
| 126811762 | 12681176 | 3 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 12.983 MG, DAY | U | 0 | 12.983 | MG | QD | ||||||
| 126811762 | 12681176 | 4 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 0.015 ?G, DAY | U | 0 | .015 | UG | QD | ||||||
| 126811762 | 12681176 | 5 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 7.790 MG, DAY | U | 0 | 7.79 | MG | QD | ||||||
| 126811762 | 12681176 | 6 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 0.089 MG, DAY | U | 0 | .089 | MG | QD | ||||||
| 126811762 | 12681176 | 7 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 129.83 ?G, DAY | U | 0 | 129.83 | UG | QD | ||||||
| 126811762 | 12681176 | 8 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 1.48 ?G, DAY | U | 0 | 1.48 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126811762 | 12681176 | 1 | Pain |
| 126811762 | 12681176 | 2 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126811762 | 12681176 | HO |
| 126811762 | 12681176 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126811762 | 12681176 | Decreased appetite | |
| 126811762 | 12681176 | Encephalopathy | |
| 126811762 | 12681176 | Fall | |
| 126811762 | 12681176 | Lethargy | |
| 126811762 | 12681176 | Mental status changes | |
| 126811762 | 12681176 | Off label use | |
| 126811762 | 12681176 | Overdose | |
| 126811762 | 12681176 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 126811762 | 12681176 | 1 | 20160809 | 0 | ||
| 126811762 | 12681176 | 2 | 20160809 | 0 | ||
| 126811762 | 12681176 | 3 | 20160809 | 0 | ||
| 126811762 | 12681176 | 4 | 20160809 | 0 | ||
| 126811762 | 12681176 | 5 | 20160809 | 0 | ||
| 126811762 | 12681176 | 6 | 20160809 | 0 | ||
| 126811762 | 12681176 | 7 | 20160809 | 0 | ||
| 126811762 | 12681176 | 8 | 20160809 | 0 |