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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127838831 | 12783883 | 1 | I | 20160910 | 20160922 | 20160927 | 20160927 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-62292BP | BOEHRINGER INGELHEIM | 80.37 | YR | M | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127838831 | 12783883 | 1 | PS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 1.5 MG | Y | 22421 | 1.5 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127838831 | 12783883 | 1 | Restless legs syndrome |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127838831 | 12783883 | Dysarthria | |
| 127838831 | 12783883 | Gait disturbance | |
| 127838831 | 12783883 | Hallucination | |
| 127838831 | 12783883 | Heart rate decreased | |
| 127838831 | 12783883 | Hypotension | |
| 127838831 | 12783883 | Insomnia | |
| 127838831 | 12783883 | Loss of consciousness | |
| 127838831 | 12783883 | Restlessness | |
| 127838831 | 12783883 | Skin discolouration |
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 |
|---|---|---|---|---|---|---|
| 127838831 | 12783883 | 1 | 20160910 | 20160912 | 0 |