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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126271821 | 12627182 | 1 | I | 2010 | 20131230 | 20160805 | 20160805 | EXP | US-SAOL THERAPEUTICS-2016SAO00332 | SAOL THERAPEUTICS | 49.92 | YR | F | Y | 0.00000 | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126271821 | 12627182 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 986.2 ?G, DAY | U | 20075 | 986.2 | UG | INJECTION | QD | |||||
| 126271821 | 12627182 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | UNK | U | 0 | INJECTION | ||||||||
| 126271821 | 12627182 | 3 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 4.197 MG, DAY | U | 0 | 4.197 | MG | QD | ||||||
| 126271821 | 12627182 | 4 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | UNK | N | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126271821 | 12627182 | 1 | Muscle spasticity |
| 126271821 | 12627182 | 2 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126271821 | 12627182 | DS |
| 126271821 | 12627182 | HO |
| 126271821 | 12627182 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126271821 | 12627182 | Accidental overdose | |
| 126271821 | 12627182 | Activities of daily living impaired | |
| 126271821 | 12627182 | Balance disorder | |
| 126271821 | 12627182 | Brain injury | |
| 126271821 | 12627182 | Drug dependence | |
| 126271821 | 12627182 | Gait disturbance | |
| 126271821 | 12627182 | Gastrointestinal disorder | |
| 126271821 | 12627182 | Hemiparesis | |
| 126271821 | 12627182 | Hernia | |
| 126271821 | 12627182 | Incorrect route of drug administration | |
| 126271821 | 12627182 | Kyphosis | |
| 126271821 | 12627182 | Lordosis | |
| 126271821 | 12627182 | Muscle atrophy | |
| 126271821 | 12627182 | Muscle spasticity | |
| 126271821 | 12627182 | Muscular dystrophy | |
| 126271821 | 12627182 | Nervous system disorder | |
| 126271821 | 12627182 | Neuralgia | |
| 126271821 | 12627182 | Neuropathy peripheral | |
| 126271821 | 12627182 | Nystagmus | |
| 126271821 | 12627182 | Overdose | |
| 126271821 | 12627182 | Pain | |
| 126271821 | 12627182 | Therapy non-responder | |
| 126271821 | 12627182 | Tinnitus | |
| 126271821 | 12627182 | Urinary incontinence | |
| 126271821 | 12627182 | Vertigo | |
| 126271821 | 12627182 | Visual impairment | |
| 126271821 | 12627182 | Wrong drug administered |
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 |
|---|---|---|---|---|---|---|
| 126271821 | 12627182 | 1 | 20131230 | 0 | ||
| 126271821 | 12627182 | 2 | 20131230 | 0 | ||
| 126271821 | 12627182 | 4 | 20140903 | 0 |