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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127069031 | 12706903 | 1 | I | 20140506 | 20140614 | 20160901 | 20160901 | EXP | US-JAZZ-2014-US-007600 | JAZZ | 79.78 | YR | M | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127069031 | 12706903 | 1 | PS | PRIALT | ZICONOTIDE ACETATE | 1 | Intrathecal | 0.037 ?G, QH | Y | 21060 | .037 | UG | |||||||
| 127069031 | 12706903 | 2 | SS | PRIALT | ZICONOTIDE ACETATE | 1 | Y | 21060 | |||||||||||
| 127069031 | 12706903 | 3 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 31.216 ?G, QH | Y | 0 | 31.216 | UG | INJECTION | ||||||
| 127069031 | 12706903 | 4 | SS | FENTANYL. | FENTANYL | 1 | Y | 0 | INJECTION | ||||||||||
| 127069031 | 12706903 | 5 | SS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 2.122 ?G, QH | Y | 0 | 2.122 | UG | INJECTION | ||||||
| 127069031 | 12706903 | 6 | SS | BACLOFEN. | BACLOFEN | 1 | Y | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127069031 | 12706903 | 1 | Pain |
| 127069031 | 12706903 | 2 | Post laminectomy syndrome |
| 127069031 | 12706903 | 3 | Pain |
| 127069031 | 12706903 | 4 | Post laminectomy syndrome |
| 127069031 | 12706903 | 5 | Pain |
| 127069031 | 12706903 | 6 | Post laminectomy syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127069031 | 12706903 | OT |
| 127069031 | 12706903 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127069031 | 12706903 | Cardiac disorder | |
| 127069031 | 12706903 | Device issue | |
| 127069031 | 12706903 | Loss of consciousness | |
| 127069031 | 12706903 | Overdose |
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 |
|---|---|---|---|---|---|---|
| 127069031 | 12706903 | 1 | 20140408 | 0 | ||
| 127069031 | 12706903 | 3 | 20140408 | 0 | ||
| 127069031 | 12706903 | 5 | 20140408 | 0 |