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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125583051 | 12558305 | 1 | I | 20140220 | 20140224 | 20160714 | 20160714 | EXP | US-SAOL THERAPEUTICS-2016SAO00160 | SAOL THERAPEUTICS | 53.90 | YR | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125583051 | 12558305 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 61.96 ?G, DAY | U | U | 20075 | 61.96 | UG | INJECTION | QD | ||||
| 125583051 | 12558305 | 2 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 3.098 MG, DAY | U | 0 | 3.098 | MG | QD | ||||||
| 125583051 | 12558305 | 3 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 5.163 MG, DAY | U | 0 | 5.163 | MG | QD | ||||||
| 125583051 | 12558305 | 4 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 154.89 ?G, DAY | U | 0 | 154.89 | UG | QD | ||||||
| 125583051 | 12558305 | 5 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | 5.163 MG, DAY | U | 0 | 5.163 | MG | QD | |||||||
| 125583051 | 12558305 | 6 | SS | BACLOFEN. | BACLOFEN | 1 | UNK | U | 20075 | INJECTION | |||||||||
| 125583051 | 12558305 | 7 | SS | BACLOFEN. | BACLOFEN | 1 | U | 20075 | INJECTION | ||||||||||
| 125583051 | 12558305 | 8 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125583051 | 12558305 | 1 | Pain |
| 125583051 | 12558305 | 6 | Pain |
| 125583051 | 12558305 | 7 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125583051 | 12558305 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125583051 | 12558305 | Burning sensation | |
| 125583051 | 12558305 | Drug withdrawal syndrome | |
| 125583051 | 12558305 | Therapy non-responder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |