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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125421842 | 12542184 | 2 | F | 20160506 | 20160714 | 20160708 | 20160729 | EXP | US-SAOL THERAPEUTICS-2016SAO00069 | SAOL THERAPEUTICS | 30.08 | YR | F | Y | 85.26000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125421842 | 12542184 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 160.5 ?G, DAY | UNK | 0 | 160.5 | UG | INJECTION | QD | |||||
| 125421842 | 12542184 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 125 ?G, DAY | UNK | 0 | 125 | UG | INJECTION | QD | |||||
| 125421842 | 12542184 | 3 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 150.1 ?G, DAY | 0 | 150.1 | UG | INJECTION | QD | ||||||
| 125421842 | 12542184 | 4 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 268.8 ?G, DAY | 0 | 268.8 | UG | INJECTION | QD | ||||||
| 125421842 | 12542184 | 5 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 165.4 ?G, DAY | 0 | 165.4 | UG | INJECTION | QD | ||||||
| 125421842 | 12542184 | 6 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 383.2 ?G, DAY | 0 | 383.2 | UG | INJECTION | QD | ||||||
| 125421842 | 12542184 | 7 | SS | GABLOFEN | BACLOFEN | 1 | Intrathecal | 160.5 ?G, DAY | UNK | 0 | 160.5 | UG | QD | ||||||
| 125421842 | 12542184 | 8 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 0.1250 MG, DAY | U | 0 | .125 | MG | QD | |||||||
| 125421842 | 12542184 | 9 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 0.1501 MG, DAY | U | 0 | .15 | MG | QD | |||||||
| 125421842 | 12542184 | 10 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 0.2688 MG, DAY | U | 0 | .268 | MG | QD | |||||||
| 125421842 | 12542184 | 11 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 0.1654 MG, DAY | U | 0 | .165 | MG | QD | |||||||
| 125421842 | 12542184 | 12 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 0.3832 MG, DAY | U | 0 | QD | |||||||||
| 125421842 | 12542184 | 13 | C | MORPHINE IR | MORPHINE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125421842 | 12542184 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125421842 | 12542184 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125421842 | 12542184 | Dizziness | |
| 125421842 | 12542184 | Implant site extravasation | |
| 125421842 | 12542184 | Incision site haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 125421842 | 12542184 | 1 | 20160504 | 0 | ||
| 125421842 | 12542184 | 2 | 201605 | 0 | ||
| 125421842 | 12542184 | 3 | 20160513 | 0 | ||
| 125421842 | 12542184 | 4 | 20160513 | 0 | ||
| 125421842 | 12542184 | 5 | 20160523 | 0 | ||
| 125421842 | 12542184 | 6 | 20160523 | 0 | ||
| 125421842 | 12542184 | 7 | 20160504 | 0 | ||
| 125421842 | 12542184 | 8 | 20160505 | 0 | ||
| 125421842 | 12542184 | 9 | 20160513 | 0 | ||
| 125421842 | 12542184 | 10 | 20160513 | 0 | ||
| 125421842 | 12542184 | 11 | 20160523 | 0 | ||
| 125421842 | 12542184 | 12 | 20160523 | 0 |