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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125837763 | 12583776 | 3 | F | 2008 | 20160824 | 20160722 | 20160907 | EXP | US-SAOL THERAPEUTICS-2016SAO00123 | SAOL THERAPEUTICS | 42.75 | YR | F | Y | 58.96000 | KG | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125837763 | 12583776 | 1 | PS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | Intrathecal | 1301.5 ?G, DAY | U | U | UNK | 20075 | 1301.5 | UG | INJECTION | QD | |||
| 125837763 | 12583776 | 2 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 4.881 MG, DAY | U | 0 | 4.881 | MG | INJECTION | QD | |||||
| 125837763 | 12583776 | 3 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Oral | 1 TABLETS, 1X/DAY | 0 | 1 | DF | TABLET | QD | ||||||
| 125837763 | 12583776 | 4 | C | IBUPROFEN. | IBUPROFEN | 1 | 1 TABLETS, AS NEEDED | 0 | 1 | DF | TABLET | ||||||||
| 125837763 | 12583776 | 5 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 1 TABLETS, AS NEEDED | 0 | 1 | DF | TABLET | ||||||||
| 125837763 | 12583776 | 6 | C | VALIUM | DIAZEPAM | 1 | Oral | 1 TABLETS, 1X/DAY | 0 | 1 | DF | TABLET | QD | ||||||
| 125837763 | 12583776 | 7 | C | LAMICTAL | LAMOTRIGINE | 1 | Oral | 1 TABLETS, 1X/DAY | 0 | 1 | DF | TABLET | QD | ||||||
| 125837763 | 12583776 | 8 | C | GABAPENTIN. | GABAPENTIN | 1 | 1 TABLETS, 3X/DAY | 0 | 1 | DF | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125837763 | 12583776 | 1 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125837763 | 12583776 | HO |
| 125837763 | 12583776 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125837763 | 12583776 | Back pain | |
| 125837763 | 12583776 | Bunion operation | |
| 125837763 | 12583776 | Device failure | |
| 125837763 | 12583776 | Drug withdrawal syndrome | |
| 125837763 | 12583776 | Foot deformity | |
| 125837763 | 12583776 | Gait disturbance | |
| 125837763 | 12583776 | Irritability | |
| 125837763 | 12583776 | Knee deformity | |
| 125837763 | 12583776 | Limb asymmetry | |
| 125837763 | 12583776 | Pain | |
| 125837763 | 12583776 | Paraplegia | |
| 125837763 | 12583776 | Rheumatoid arthritis | |
| 125837763 | 12583776 | Tenotomy |
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 |
|---|---|---|---|---|---|---|
| 125837763 | 12583776 | 5 | 20150923 | 0 | ||
| 125837763 | 12583776 | 6 | 20160516 | 0 | ||
| 125837763 | 12583776 | 8 | 20150430 | 0 |