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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116059004 | 11605900 | 4 | F | 20160329 | 20160819 | 20151007 | 20160824 | EXP | US-GLAXOSMITHKLINE-US2015142173 | GLAXOSMITHKLINE | 83.39 | YR | F | Y | 0.00000 | 20160824 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116059004 | 11605900 | 1 | PS | REQUIP XL | ROPINIROLE HYDROCHLORIDE | 1 | Oral | UNK, U | U | 22008 | PROLONGED-RELEASE TABLET | ||||||||
| 116059004 | 11605900 | 2 | SS | REQUIP XL | ROPINIROLE HYDROCHLORIDE | 1 | Oral | 8 MG, QD | U | 22008 | 8 | MG | PROLONGED-RELEASE TABLET | QD | |||||
| 116059004 | 11605900 | 3 | SS | REQUIP | ROPINIROLE HYDROCHLORIDE | 1 | 0.5 MG, UNK | UNKNOWN | 0 | .5 | MG | TABLET | |||||||
| 116059004 | 11605900 | 4 | SS | ROPINIROLE. | ROPINIROLE | 1 | Unknown | 1.5 MG, QD | U | 0 | 1.5 | MG | QD | ||||||
| 116059004 | 11605900 | 5 | C | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 6 | C | ECOTRIN | ASPIRIN | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 7 | C | TOPAMAX | TOPIRAMATE | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 8 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 9 | C | ALENDRONATE | ALENDRONATE SODIUM | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 10 | C | BUTALBITAL + PARACETAMOL | 2 | U | 0 | ||||||||||||
| 116059004 | 11605900 | 11 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 12 | C | LOSARTAN. | LOSARTAN | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 13 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 14 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 15 | C | PRAVASTATIN. | PRAVASTATIN | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 16 | C | PRESERVISION | MINERALSVITAMINS | 1 | U | 0 | |||||||||||
| 116059004 | 11605900 | 17 | C | TRAMADOL. | TRAMADOL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116059004 | 11605900 | 1 | Back disorder |
| 116059004 | 11605900 | 3 | Spinal laminectomy |
| 116059004 | 11605900 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116059004 | 11605900 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116059004 | 11605900 | Back pain | |
| 116059004 | 11605900 | Cerebrovascular accident | |
| 116059004 | 11605900 | Contusion | |
| 116059004 | 11605900 | Drug ineffective for unapproved indication | |
| 116059004 | 11605900 | Fall | |
| 116059004 | 11605900 | Ligament sprain | |
| 116059004 | 11605900 | Muscle spasms | |
| 116059004 | 11605900 | Neuralgia | |
| 116059004 | 11605900 | Off label use | |
| 116059004 | 11605900 | Pain | |
| 116059004 | 11605900 | Product substitution issue | |
| 116059004 | 11605900 | Product use issue | |
| 116059004 | 11605900 | Road traffic accident | |
| 116059004 | 11605900 | Sleep disorder | |
| 116059004 | 11605900 | Spinal fracture |
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 |
|---|---|---|---|---|---|---|
| 116059004 | 11605900 | 3 | 2013 | 0 | ||
| 116059004 | 11605900 | 4 | 2014 | 0 |