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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287091 | 12528709 | 1 | I | 200802 | 20140605 | 20160705 | 20160705 | EXP | US-SAOL THERAPEUTICS-2016SAO00029 | SAOL THERAPEUTICS | 17.69 | YR | M | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287091 | 12528709 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | U | U | 20075 | INJECTION | ||||||||
| 125287091 | 12528709 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 125287091 | 12528709 | 3 | SS | LIORESAL | BACLOFEN | 1 | 400 ?G, DAY | U | 0 | 400 | UG | INJECTION | QD | ||||||
| 125287091 | 12528709 | 4 | SS | LIORESAL | BACLOFEN | 1 | 300 ?G, DAY | U | 0 | 300 | UG | INJECTION | QD | ||||||
| 125287091 | 12528709 | 5 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 1301.7 ?G, DAY | U | 0 | 1301.7 | UG | INJECTION | QD | |||||
| 125287091 | 12528709 | 6 | SS | LIORESAL | BACLOFEN | 1 | 1420.8 ?G, DAY | U | 0 | 1420.8 | UG | INJECTION | QD | ||||||
| 125287091 | 12528709 | 7 | SS | LIORESAL | BACLOFEN | 1 | 120 ?G, DAY | U | 0 | 120 | UG | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125287091 | 12528709 | 1 | Cerebral palsy |
| 125287091 | 12528709 | 2 | Muscle spasticity |
| 125287091 | 12528709 | 3 | Cerebral palsy |
| 125287091 | 12528709 | 4 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125287091 | 12528709 | OT |
| 125287091 | 12528709 | HO |
| 125287091 | 12528709 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125287091 | 12528709 | Aphasia | |
| 125287091 | 12528709 | Arachnoiditis | |
| 125287091 | 12528709 | Cerebrospinal fluid leakage | |
| 125287091 | 12528709 | Cerebrospinal fluid retention | |
| 125287091 | 12528709 | Device dislocation | |
| 125287091 | 12528709 | Drug withdrawal syndrome | |
| 125287091 | 12528709 | Hallucination, visual | |
| 125287091 | 12528709 | Heart rate increased | |
| 125287091 | 12528709 | Injury associated with device | |
| 125287091 | 12528709 | Insomnia | |
| 125287091 | 12528709 | Multiple organ dysfunction syndrome | |
| 125287091 | 12528709 | Overdose | |
| 125287091 | 12528709 | Pathogen resistance | |
| 125287091 | 12528709 | Performance status decreased | |
| 125287091 | 12528709 | Pseudomonas infection | |
| 125287091 | 12528709 | Somnolence | |
| 125287091 | 12528709 | Staphylococcal infection | |
| 125287091 | 12528709 | Thinking abnormal | |
| 125287091 | 12528709 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 125287091 | 12528709 | 3 | 20141124 | 20141125 | 0 | |
| 125287091 | 12528709 | 4 | 20141125 | 0 |