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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125463001 | 12546300 | 1 | I | 20140512 | 20160704 | 20160711 | 20160711 | EXP | PHJP2016JP019003 | NOVARTIS | 73.00 | YR | M | Y | 0.00000 | 20160711 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125463001 | 12546300 | 1 | PS | COMTAN | ENTACAPONE | 1 | Oral | 100 MG, TID | 20796 | 100 | MG | TABLET | TID | ||||||
| 125463001 | 12546300 | 2 | SS | ROTIGOTINE | ROTIGOTINE | 1 | Transdermal | 2.25 MG, QD | 808 | MG | 0 | 2.25 | MG | TAPE (INCLUDING POULTICE) | QD | ||||
| 125463001 | 12546300 | 3 | SS | ROTIGOTINE | ROTIGOTINE | 1 | Transdermal | 4.5 MG, QD | 808 | MG | 0 | 4.5 | MG | TAPE (INCLUDING POULTICE) | QD | ||||
| 125463001 | 12546300 | 4 | SS | ROTIGOTINE | ROTIGOTINE | 1 | Transdermal | 9 MG, QD | 808 | MG | 0 | 9 | MG | TAPE (INCLUDING POULTICE) | QD | ||||
| 125463001 | 12546300 | 5 | SS | ROTIGOTINE | ROTIGOTINE | 1 | Transdermal | 13.5 MG, QD | 808 | MG | 0 | 13.5 | MG | TAPE (INCLUDING POULTICE) | QD | ||||
| 125463001 | 12546300 | 6 | SS | ROTIGOTINE | ROTIGOTINE | 1 | Transdermal | 18 MG, QD | 808 | MG | 0 | 18 | MG | TAPE (INCLUDING POULTICE) | QD | ||||
| 125463001 | 12546300 | 7 | SS | ROTIGOTINE | ROTIGOTINE | 1 | Transdermal | 22.5 MG, QD | 808 | MG | 0 | 22.5 | MG | TAPE (INCLUDING POULTICE) | QD | ||||
| 125463001 | 12546300 | 8 | SS | MENESIT | CARBIDOPALEVODOPA | 1 | Oral | 150 MG, QID | 0 | 150 | MG | TABLET | QID | ||||||
| 125463001 | 12546300 | 9 | SS | REQUIP | ROPINIROLE HYDROCHLORIDE | 1 | Oral | 16 MG, QD | Y | 0 | 16 | MG | MODIFIED RELEASE TABLET | QD | |||||
| 125463001 | 12546300 | 10 | SS | REQUIP | ROPINIROLE HYDROCHLORIDE | 1 | Oral | 4 MG, BID | Y | 0 | 4 | MG | MODIFIED RELEASE TABLET | BID | |||||
| 125463001 | 12546300 | 11 | SS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 4.5 MG, QD | 0 | 4.5 | MG | EXTENDED RELEASE TABLET | QD | ||||||
| 125463001 | 12546300 | 12 | SS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 0.75 MG, BID | 0 | .75 | MG | EXTENDED RELEASE TABLET | BID | ||||||
| 125463001 | 12546300 | 13 | SS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 0.75 MG, BID | 0 | .75 | MG | EXTENDED RELEASE TABLET | BID | ||||||
| 125463001 | 12546300 | 14 | SS | FP-OD | SELEGILINE HYDROCHLORIDE | 1 | Oral | 2.5 MG, QD | 0 | 2.5 | MG | TABLET | QD | ||||||
| 125463001 | 12546300 | 15 | SS | NOURIAST | ISTRADEFYLLINE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | TABLET | QD | ||||||
| 125463001 | 12546300 | 16 | SS | TRERIEF | ZONISAMIDE | 1 | Oral | 50 MG, QD | 0 | 50 | MG | TABLET | QD | ||||||
| 125463001 | 12546300 | 17 | C | GANATON | ITOPRIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 125463001 | 12546300 | 18 | C | METHYCOOL | METHYLCOBALAMIN | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 125463001 | 12546300 | 19 | C | AMLODIPINE BESILATE | AMLODIPINE BESYLATE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 125463001 | 12546300 | 20 | C | MICARDIS | TELMISARTAN | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 125463001 | 12546300 | 21 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 125463001 | 12546300 | 22 | C | MAGMITT | MAGNESIUM OXIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 125463001 | 12546300 | 23 | C | BROTIZOLAM | BROTIZOLAM | 1 | Unknown | UNK | Y | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125463001 | 12546300 | 1 | Parkinson's disease |
| 125463001 | 12546300 | 2 | Parkinson's disease |
| 125463001 | 12546300 | 8 | Parkinson's disease |
| 125463001 | 12546300 | 9 | Parkinson's disease |
| 125463001 | 12546300 | 11 | Parkinson's disease |
| 125463001 | 12546300 | 14 | Parkinson's disease |
| 125463001 | 12546300 | 15 | Parkinson's disease |
| 125463001 | 12546300 | 16 | Parkinson's disease |
| 125463001 | 12546300 | 17 | Product used for unknown indication |
| 125463001 | 12546300 | 18 | Product used for unknown indication |
| 125463001 | 12546300 | 19 | Hypertension |
| 125463001 | 12546300 | 20 | Hypertension |
| 125463001 | 12546300 | 21 | Product used for unknown indication |
| 125463001 | 12546300 | 22 | Product used for unknown indication |
| 125463001 | 12546300 | 23 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125463001 | 12546300 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125463001 | 12546300 | Application site erythema | |
| 125463001 | 12546300 | Application site pruritus | |
| 125463001 | 12546300 | Benign prostatic hyperplasia | |
| 125463001 | 12546300 | Dyskinesia | |
| 125463001 | 12546300 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 125463001 | 12546300 | 2 | 20140217 | 20140303 | 0 | |
| 125463001 | 12546300 | 3 | 20140304 | 20140331 | 0 | |
| 125463001 | 12546300 | 4 | 20140401 | 20140414 | 0 | |
| 125463001 | 12546300 | 5 | 20140415 | 20140512 | 0 | |
| 125463001 | 12546300 | 6 | 20140513 | 20141226 | 0 | |
| 125463001 | 12546300 | 7 | 20141227 | 0 | ||
| 125463001 | 12546300 | 9 | 20141118 | 0 | ||
| 125463001 | 12546300 | 10 | 20141119 | 0 | ||
| 125463001 | 12546300 | 11 | 20140526 | 0 | ||
| 125463001 | 12546300 | 12 | 20140527 | 20141118 | 0 | |
| 125463001 | 12546300 | 13 | 20141119 | 0 | ||
| 125463001 | 12546300 | 15 | 20130710 | 0 | ||
| 125463001 | 12546300 | 16 | 20140428 | 0 | ||
| 125463001 | 12546300 | 20 | 20131128 | 0 | ||
| 125463001 | 12546300 | 22 | 20131106 | 0 | ||
| 125463001 | 12546300 | 23 | 20140525 | 0 |