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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269431 | 12626943 | 1 | I | 20160625 | 20160705 | 20160805 | 20160805 | EXP | US-SAOL THERAPEUTICS-2016SAO00189 | SAOL THERAPEUTICS | 66.25 | YR | M | Y | 0.00000 | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269431 | 12626943 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 150 ?G, DAY | CS0093 | 20075 | 150 | UG | INJECTION | QD | |||||
| 126269431 | 12626943 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 177.9 ?G, DAY | CS0093 | 20075 | 177.9 | UG | INJECTION | QD | |||||
| 126269431 | 12626943 | 3 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 10 MG, 1X/DAY | 0 | 10 | MG | QD | ||||||||
| 126269431 | 12626943 | 4 | C | ENALAPRIL | ENALAPRIL | 1 | 10 MG, 1X/DAY | 0 | 10 | MG | QD | ||||||||
| 126269431 | 12626943 | 5 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | 10 MG, 1X/DAY | 0 | 10 | MG | QD | ||||||||
| 126269431 | 12626943 | 6 | C | HYDROCODONE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE | 1 | 10/325 | 0 | |||||||||||
| 126269431 | 12626943 | 7 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 25 MG, AS NEEDED | 0 | 25 | MG | |||||||||
| 126269431 | 12626943 | 8 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 50 MG, AS NEEDED | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126269431 | 12626943 | 1 | Hemiparesis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126269431 | 12626943 | HO |
| 126269431 | 12626943 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126269431 | 12626943 | Burning sensation | |
| 126269431 | 12626943 | Drug withdrawal syndrome | |
| 126269431 | 12626943 | Hypoaesthesia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |