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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287102 | 12528710 | 2 | F | 20151127 | 20160805 | 20160705 | 20160819 | EXP | US-SAOL THERAPEUTICS-2016SAO00034 | SAOL THERAPEUTICS | 55.59 | YR | M | Y | 55.78000 | KG | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287102 | 12528710 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | UNK | 2610.46509 | UG | Y | 20075 | INJECTION | ||||||
| 125287102 | 12528710 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 104.41 ?G, DAY | 2610.46509 | UG | Y | DS0092A | 20075 | 104.41 | UG | INJECTION | QD | ||
| 125287102 | 12528710 | 3 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 50 ?G, DAY | 2610.46509 | UG | Y | 20075 | 50 | UG | INJECTION | QD | |||
| 125287102 | 12528710 | 4 | SS | LIORESAL | BACLOFEN | 1 | UNK | 2610.46509 | UG | Y | 20075 | INJECTION | |||||||
| 125287102 | 12528710 | 5 | SS | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 6 | SS | ALBUTEROL. | ALBUTEROL | 1 | UNK | U | 0 | ||||||||||
| 125287102 | 12528710 | 7 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 8 | SS | PRAVACHOL | PRAVASTATIN SODIUM | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 9 | SS | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 10 | SS | KENALOG | TRIAMCINOLONE ACETONIDE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 11 | SS | HUMALOG | INSULIN LISPRO | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 12 | SS | SENOKOT | SENNOSIDES | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 13 | SS | VIAGRA | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 14 | SS | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | U | 0 | CREAM | ||||||||||
| 125287102 | 12528710 | 15 | SS | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 16 | SS | TECFIDERA | DIMETHYL FUMARATE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 17 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 18 | SS | NEURONTIN | GABAPENTIN | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 19 | SS | GLUCOTROL | GLIPIZIDE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 20 | SS | HYDRODIURIL | HYDROCHLOROTHIAZIDE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 21 | SS | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 22 | SS | FISH OIL | FISH OIL | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 23 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 24 | SS | NORVASC | AMLODIPINE BESYLATE | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 25 | SS | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 26 | SS | BOTOX | ONABOTULINUMTOXINA | 1 | U | 0 | |||||||||||
| 125287102 | 12528710 | 27 | SS | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125287102 | 12528710 | 1 | Multiple sclerosis |
| 125287102 | 12528710 | 2 | Quadriplegia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125287102 | 12528710 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125287102 | 12528710 | Device failure | |
| 125287102 | 12528710 | Drug withdrawal syndrome | |
| 125287102 | 12528710 | Headache | |
| 125287102 | 12528710 | Myalgia | |
| 125287102 | 12528710 | Urinary retention |
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 |
|---|---|---|---|---|---|---|
| 125287102 | 12528710 | 1 | 20040820 | 20151103 | 0 | |
| 125287102 | 12528710 | 2 | 20151103 | 20151128 | 0 | |
| 125287102 | 12528710 | 3 | 20151215 | 0 |