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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127280231 | 12728023 | 1 | I | 20160731 | 20160901 | 20160909 | 20160909 | EXP | IT-OTSUKA-2016_021499 | OTSUKA | 0.00 | M | Y | 88.00000 | KG | 20160909 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127280231 | 12728023 | 1 | PS | PLETAL | CILOSTAZOL | 1 | Oral | 200 MG, QD | 4600 | MG | Y | 20863 | 200 | MG | TABLET | QD | |||
| 127280231 | 12728023 | 2 | C | CARDIOPIRIN | ASPIRIN | 1 | Unknown | UNK (FROM 7 YEARS) | 0 | ||||||||||
| 127280231 | 12728023 | 3 | C | OMNIC | TAMSULOSIN HYDROCHLORIDE | 1 | Unknown | UNK, (FROM 1 YEAR) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127280231 | 12728023 | 1 | Peripheral arterial occlusive disease |
| 127280231 | 12728023 | 2 | Product used for unknown indication |
| 127280231 | 12728023 | 3 | Benign prostatic hyperplasia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127280231 | 12728023 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127280231 | 12728023 | Bedridden | |
| 127280231 | 12728023 | Dizziness postural | |
| 127280231 | 12728023 | Headache | |
| 127280231 | 12728023 | Malaise | |
| 127280231 | 12728023 | Product use issue | |
| 127280231 | 12728023 | Tachycardia | |
| 127280231 | 12728023 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 127280231 | 12728023 | 1 | 20160731 | 20160825 | 0 |