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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127472261 | 12747226 | 1 | I | 201608 | 20160830 | 20160915 | 20160915 | EXP | US-SAOL THERAPEUTICS-2016SAO00611 | SAOL THERAPEUTICS | 19.18 | YR | F | Y | 40.36000 | KG | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127472261 | 12747226 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 130.2 ?G, DAY | U | U | 20075 | 130.2 | UG | INJECTION | QD | ||||
| 127472261 | 12747226 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 100 ?GDAY | U | U | 20075 | 100 | UG | INJECTION | QD | ||||
| 127472261 | 12747226 | 3 | C | KEPPRA | LEVETIRACETAM | 1 | U | 0 | |||||||||||
| 127472261 | 12747226 | 4 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127472261 | 12747226 | 1 | Muscle spasticity |
| 127472261 | 12747226 | 2 | Cerebral palsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127472261 | 12747226 | HO |
| 127472261 | 12747226 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127472261 | 12747226 | Akathisia | |
| 127472261 | 12747226 | Cerebrospinal fluid leakage | |
| 127472261 | 12747226 | Device connection issue | |
| 127472261 | 12747226 | Hypotension | |
| 127472261 | 12747226 | Muscle spasticity | |
| 127472261 | 12747226 | Pruritus | |
| 127472261 | 12747226 | Seroma | |
| 127472261 | 12747226 | Therapeutic response unexpected |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |