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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124060302 | 12406030 | 2 | F | 20160620 | 20160526 | 20160712 | PER | US-BAYER-2016-084705 | BAYER | 55.00 | YR | A | M | Y | 0.00000 | 20160712 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124060302 | 12406030 | 1 | PS | LEVITRA | VARDENAFIL HYDROCHLORIDE TRIHYDRATE | 1 | Oral | UNK | 21400 | FILM-COATED TABLET | |||||||||
| 124060302 | 12406030 | 2 | SS | LEVITRA | VARDENAFIL HYDROCHLORIDE TRIHYDRATE | 1 | Oral | 5 MG, 1/4 TABLET | BXHOU21 | 21400 | 5 | MG | FILM-COATED TABLET | ||||||
| 124060302 | 12406030 | 3 | SS | LEVITRA | VARDENAFIL HYDROCHLORIDE TRIHYDRATE | 1 | Oral | 5 MG, 1/4 TABLET | BXHOU21 | 21400 | 5 | MG | FILM-COATED TABLET | ||||||
| 124060302 | 12406030 | 4 | SS | LEVITRA | VARDENAFIL HYDROCHLORIDE TRIHYDRATE | 1 | Oral | 10 MG, 1/2 TABLET | BXHOU21 | 21400 | 10 | MG | FILM-COATED TABLET | ||||||
| 124060302 | 12406030 | 5 | SS | LEVITRA | VARDENAFIL HYDROCHLORIDE TRIHYDRATE | 1 | Oral | 10 MG, 1/2 TABLET | BXHOU21 | 21400 | 10 | MG | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124060302 | 12406030 | 1 | Erectile dysfunction |
| 124060302 | 12406030 | 2 | Erectile dysfunction |
| 124060302 | 12406030 | 3 | Erectile dysfunction |
| 124060302 | 12406030 | 4 | Erectile dysfunction |
| 124060302 | 12406030 | 5 | Erectile dysfunction |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124060302 | 12406030 | Drug ineffective | |
| 124060302 | 12406030 | Flushing | |
| 124060302 | 12406030 | Product packaging issue | |
| 124060302 | 12406030 | Product quality issue | |
| 124060302 | 12406030 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 124060302 | 12406030 | 1 | 2014 | 0 | ||
| 124060302 | 12406030 | 2 | 20160319 | 20160319 | 0 | |
| 124060302 | 12406030 | 3 | 20160324 | 20160324 | 0 | |
| 124060302 | 12406030 | 4 | 20160401 | 20160401 | 0 | |
| 124060302 | 12406030 | 5 | 20160422 | 20160422 | 0 |