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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127890451 | 12789045 | 1 | I | 201604 | 20160422 | 20160928 | 20160928 | EXP | US-SAOL THERAPEUTICS-2016SAO00723 | SAOL THERAPEUTICS | 0.00 | M | Y | 0.00000 | 20160928 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127890451 | 12789045 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | UNK | U | U | 20075 | INJECTION | |||||||
| 127890451 | 12789045 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 140 ?G, DAY | U | U | 20075 | 140 | UG | INJECTION | QD | ||||
| 127890451 | 12789045 | 3 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | UNK | U | 0 | |||||||||
| 127890451 | 12789045 | 4 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 270 ?G, DAY | U | 0 | 270 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127890451 | 12789045 | 1 | Muscle spasticity |
| 127890451 | 12789045 | 2 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127890451 | 12789045 | OT |
| 127890451 | 12789045 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127890451 | 12789045 | Device malfunction | |
| 127890451 | 12789045 | Drug withdrawal syndrome | |
| 127890451 | 12789045 | Dyskinesia | |
| 127890451 | 12789045 | Dyspnoea | |
| 127890451 | 12789045 | Feeling abnormal | |
| 127890451 | 12789045 | Loss of consciousness | |
| 127890451 | 12789045 | Medical device discomfort | |
| 127890451 | 12789045 | Restlessness | |
| 127890451 | 12789045 | Skin discolouration | |
| 127890451 | 12789045 | Speech disorder | |
| 127890451 | 12789045 | Unevaluable event |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |