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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269453 | 12626945 | 3 | F | 20160625 | 20160825 | 20160805 | 20160909 | EXP | US-SAOL THERAPEUTICS-2016SAO00320 | SAOL THERAPEUTICS | 32.40 | YR | M | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269453 | 12626945 | 1 | PS | LIORESAL | BACLOFEN | 1 | UNK | 20075 | INJECTION | ||||||||||
| 126269453 | 12626945 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 382.3 ?G, DAY | 20075 | 382.3 | UG | INJECTION | QD | ||||||
| 126269453 | 12626945 | 3 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 498.2 ?G, DAY | 20075 | 498.2 | UG | INJECTION | QD | ||||||
| 126269453 | 12626945 | 4 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 749 ?G, DAY | 20075 | 749 | UG | INJECTION | QD | ||||||
| 126269453 | 12626945 | 5 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 360 ?G, DAY | 20075 | 360 | UG | INJECTION | QD | ||||||
| 126269453 | 12626945 | 6 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 540-570 ?G, DAY | 20075 | 540 | UG | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126269453 | 12626945 | 1 | Muscle spasticity |
| 126269453 | 12626945 | 2 | Spinal cord injury |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126269453 | 12626945 | HO |
| 126269453 | 12626945 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126269453 | 12626945 | Device alarm issue | |
| 126269453 | 12626945 | Device battery issue | |
| 126269453 | 12626945 | Drug withdrawal syndrome | |
| 126269453 | 12626945 | Hypertonia | |
| 126269453 | 12626945 | Pneumonia | |
| 126269453 | 12626945 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 126269453 | 12626945 | 1 | 20160713 | 0 | ||
| 126269453 | 12626945 | 2 | 20160713 | 20160720 | 0 | |
| 126269453 | 12626945 | 3 | 20160720 | 0 | ||
| 126269453 | 12626945 | 4 | 201607 | 0 | ||
| 126269453 | 12626945 | 5 | 201607 | 20160810 | 0 | |
| 126269453 | 12626945 | 6 | 20160810 | 0 |