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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125377992 | 12537799 | 2 | F | 2016 | 20160720 | 20160707 | 20160804 | EXP | US-SAOL THERAPEUTICS-2016SAO00091 | SAOL THERAPEUTICS | 55.30 | YR | F | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125377992 | 12537799 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 260 ?G, DAY | 20075 | 260 | UG | INJECTION | QD | ||||||
| 125377992 | 12537799 | 2 | SS | LIORESAL | BACLOFEN | 1 | 20075 | INJECTION | |||||||||||
| 125377992 | 12537799 | 3 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 0.8 UNK, UNK | U | U | 0 | ||||||||
| 125377992 | 12537799 | 4 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 125377992 | 12537799 | 5 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 0 | |||||||||||
| 125377992 | 12537799 | 6 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Oral | 0 | |||||||||||
| 125377992 | 12537799 | 7 | C | UNSPECIFIED HYPERTENSION (DIURETIC) | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125377992 | 12537799 | 1 | Muscle spasticity |
| 125377992 | 12537799 | 2 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125377992 | 12537799 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125377992 | 12537799 | Blood pressure increased | |
| 125377992 | 12537799 | Chest discomfort | |
| 125377992 | 12537799 | Dizziness | |
| 125377992 | 12537799 | Drug withdrawal syndrome | |
| 125377992 | 12537799 | Gait disturbance | |
| 125377992 | 12537799 | Hypoaesthesia | |
| 125377992 | 12537799 | Muscle spasticity | |
| 125377992 | 12537799 | Nasal congestion | |
| 125377992 | 12537799 | Nausea | |
| 125377992 | 12537799 | Pain | |
| 125377992 | 12537799 | Peripheral coldness | |
| 125377992 | 12537799 | Therapy non-responder | |
| 125377992 | 12537799 | Ventricular extrasystoles | |
| 125377992 | 12537799 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |