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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125321372 | 12532137 | 2 | F | 2016 | 20160712 | 20160706 | 20160727 | EXP | US-SAOL THERAPEUTICS-2016SAO00001 | SAOL THERAPEUTICS | 66.90 | YR | M | Y | 83.90000 | KG | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125321372 | 12532137 | 1 | PS | LIORESAL | BACLOFEN | 1 | 1200 ?G, DAY | Y | 20075 | 1200 | UG | INJECTION | QD | ||||||
| 125321372 | 12532137 | 2 | SS | LIORESAL | BACLOFEN | 1 | 1600 ?G/ML, DAY | Y | 20075 | INJECTION | QD | ||||||||
| 125321372 | 12532137 | 3 | SS | LIORESAL | BACLOFEN | 1 | 2000 ?G/ML, DAY | Y | 20075 | INJECTION | QD | ||||||||
| 125321372 | 12532137 | 4 | SS | LIORESAL | BACLOFEN | 1 | 1675 UNK, UNK | Y | 20075 | 1675 | UG | INJECTION | QD | ||||||
| 125321372 | 12532137 | 5 | SS | LIORESAL | BACLOFEN | 1 | 1200 ?G/ML, DAY | Y | 20075 | INJECTION | QD | ||||||||
| 125321372 | 12532137 | 6 | SS | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | UNK | Y | U | 0 | TABLET | ||||||||
| 125321372 | 12532137 | 7 | SS | IBUPROFEN. | IBUPROFEN | 1 | Y | U | 0 | ||||||||||
| 125321372 | 12532137 | 8 | SS | PAIN MEDICATIONS (UNSPECIFIED) | UNSPECIFIED INGREDIENT | 1 | Y | U | 0 | ||||||||||
| 125321372 | 12532137 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | 600 MG, 3X/DAY | 0 | 600 | MG | CAPSULE | TID | |||||||
| 125321372 | 12532137 | 10 | C | VALIUM | DIAZEPAM | 1 | 5 MG, 3X/DAY | 0 | 5 | MG | TABLET | TID | |||||||
| 125321372 | 12532137 | 11 | C | MESTINON | PYRIDOSTIGMINE BROMIDE | 1 | 0 | SYRUP | |||||||||||
| 125321372 | 12532137 | 12 | C | LASIX | FUROSEMIDE | 1 | 20 MG, 2X/DAY | 0 | 20 | MG | TABLET | BID | |||||||
| 125321372 | 12532137 | 13 | C | DOXAZOSIN | DOXAZOSINDOXAZOSIN MESYLATE | 1 | 2 MG, 1X/DAY | 0 | 2 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125321372 | 12532137 | 1 | Muscle spasticity |
| 125321372 | 12532137 | 2 | Stiff person syndrome |
| 125321372 | 12532137 | 6 | Muscle spasticity |
| 125321372 | 12532137 | 9 | Pain |
| 125321372 | 12532137 | 10 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125321372 | 12532137 | HO |
| 125321372 | 12532137 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125321372 | 12532137 | Arrhythmia | |
| 125321372 | 12532137 | Body temperature decreased | |
| 125321372 | 12532137 | Hallucination | |
| 125321372 | 12532137 | Hallucination, auditory | |
| 125321372 | 12532137 | Heart rate decreased | |
| 125321372 | 12532137 | Hypertension | |
| 125321372 | 12532137 | Memory impairment | |
| 125321372 | 12532137 | Muscle spasms | |
| 125321372 | 12532137 | Overdose | |
| 125321372 | 12532137 | Pain | |
| 125321372 | 12532137 | Personality disorder | |
| 125321372 | 12532137 | Psychotic disorder | |
| 125321372 | 12532137 | Respiratory rate decreased | |
| 125321372 | 12532137 | Unresponsive to stimuli |
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 |
|---|---|---|---|---|---|---|
| 125321372 | 12532137 | 1 | 20121218 | 0 | ||
| 125321372 | 12532137 | 2 | 201604 | 0 | ||
| 125321372 | 12532137 | 3 | 201604 | 0 | ||
| 125321372 | 12532137 | 4 | 2016 | 2016 | 0 | |
| 125321372 | 12532137 | 5 | 201604 | 0 | ||
| 125321372 | 12532137 | 6 | 20160411 | 0 |