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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127867071 | 12786707 | 1 | I | 201210 | 20121023 | 20160927 | 20160927 | EXP | US-SAOL THERAPEUTICS-2016SAO00635 | SAOL THERAPEUTICS | 52.45 | YR | F | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127867071 | 12786707 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 1.876 MG, DAY | U | U | 20075 | 1.876 | MG | INJECTION | QD | ||||
| 127867071 | 12786707 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 0.399 MGDAY | U | U | 20075 | .399 | MG | INJECTION | QD | ||||
| 127867071 | 12786707 | 3 | SS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 0.199 MG, DAY | U | U | 20075 | .199 | MG | INJECTION | QD | ||||
| 127867071 | 12786707 | 4 | SS | BACLOFEN. | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 127867071 | 12786707 | 5 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 663.07 ?GDAY | U | 0 | 663.7 | UG | QD | ||||||
| 127867071 | 12786707 | 6 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 119.88 ?GDAY | U | 0 | 119.88 | UG | QD | ||||||
| 127867071 | 12786707 | 7 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 59.94 ?G, DAY | U | 0 | 59.94 | UG | QD | ||||||
| 127867071 | 12786707 | 8 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 22.523 MGDAY | U | 0 | 22.523 | MG | QD | ||||||
| 127867071 | 12786707 | 9 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 4.795 MG, DAY | U | 0 | 4.795 | MG | QD | ||||||
| 127867071 | 12786707 | 10 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 2.398 MG, DAY | U | 0 | 2.398 | MG | QD | ||||||
| 127867071 | 12786707 | 11 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 9.384 MGDAY | U | 0 | 9.384 | MG | QD | ||||||
| 127867071 | 12786707 | 12 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 1.997 MGDAY | U | 0 | 1.997 | MG | QD | ||||||
| 127867071 | 12786707 | 13 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 0.999 MG, DAY | U | 0 | .999 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127867071 | 12786707 | 1 | Back pain |
| 127867071 | 12786707 | 2 | Spinal pain |
| 127867071 | 12786707 | 3 | Pain |
| 127867071 | 12786707 | 4 | Post laminectomy syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127867071 | 12786707 | HO |
| 127867071 | 12786707 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127867071 | 12786707 | Accidental overdose | |
| 127867071 | 12786707 | Device infusion issue | |
| 127867071 | 12786707 | Incontinence | |
| 127867071 | 12786707 | Lethargy | |
| 127867071 | 12786707 | Medication error | |
| 127867071 | 12786707 | Off label use | |
| 127867071 | 12786707 | Respiratory depression |
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 |
|---|---|---|---|---|---|---|
| 127867071 | 12786707 | 1 | 20121022 | 0 | ||
| 127867071 | 12786707 | 2 | 20121022 | 0 | ||
| 127867071 | 12786707 | 3 | 20121023 | 0 | ||
| 127867071 | 12786707 | 5 | 20121022 | 0 | ||
| 127867071 | 12786707 | 6 | 20121022 | 0 | ||
| 127867071 | 12786707 | 7 | 20121023 | 0 | ||
| 127867071 | 12786707 | 8 | 20121022 | 0 | ||
| 127867071 | 12786707 | 9 | 20121022 | 0 | ||
| 127867071 | 12786707 | 10 | 20121023 | 0 | ||
| 127867071 | 12786707 | 11 | 20121022 | 0 | ||
| 127867071 | 12786707 | 12 | 20121022 | 0 | ||
| 127867071 | 12786707 | 13 | 20121023 | 0 |