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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125498902 | 12549890 | 2 | F | 201503 | 20160802 | 20160712 | 20160817 | EXP | US-SAOL THERAPEUTICS-2016SAO00119 | SAOL THERAPEUTICS | 25.48 | YR | M | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125498902 | 12549890 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 320 ?G, DAY | U | U | 20075 | 320 | UG | INJECTION | QD | ||||
| 125498902 | 12549890 | 2 | SS | LIORESAL | BACLOFEN | 1 | 664.7 ?G, DAY | U | 0 | 664.7 | UG | INJECTION | QD | ||||||
| 125498902 | 12549890 | 3 | SS | NUEDEXTA | DEXTROMETHORPHAN HYDROBROMIDEQUINIDINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 125498902 | 12549890 | 4 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125498902 | 12549890 | 5 | SS | COLACE | DOCUSATE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 125498902 | 12549890 | 6 | SS | CLARITIN | LORATADINE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125498902 | 12549890 | 1 | Muscle spasticity |
| 125498902 | 12549890 | 2 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125498902 | 12549890 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125498902 | 12549890 | Cerebrospinal fluid leakage | |
| 125498902 | 12549890 | Device computer issue | |
| 125498902 | 12549890 | Device connection issue | |
| 125498902 | 12549890 | Drug withdrawal syndrome | |
| 125498902 | 12549890 | Implant site dehiscence | |
| 125498902 | 12549890 | Implant site discharge | |
| 125498902 | 12549890 | Implant site extravasation | |
| 125498902 | 12549890 | Implant site swelling | |
| 125498902 | 12549890 | Muscle spasms | |
| 125498902 | 12549890 | Torticollis | |
| 125498902 | 12549890 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 125498902 | 12549890 | 2 | 2008 | 0 |