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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126047871 | 12604787 | 1 | I | 20160718 | 20160728 | 20160728 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-49546YA | BOEHRINGER INGELHEIM | 0.00 | M | Y | 186.00000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126047871 | 12604787 | 1 | PS | Tamsulosina | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | FORMULATION:MODIFIED-RELEASE CAPSULE,HARD; STRENGTH: 0.4MG;DAILY DOSE:2 DF,30 MINUTES SAME MEAL EACH | 20579 | ||||||||||
| 126047871 | 12604787 | 2 | SS | TOVIAZ | FESOTERODINE FUMARATE | 1 | Unknown | 4 MG | U | 0 | 4 | MG | TABLET | QD | |||||
| 126047871 | 12604787 | 3 | SS | TOVIAZ | FESOTERODINE FUMARATE | 1 | Oral | 8 MG | U | 0 | 8 | MG | TABLET | QD | |||||
| 126047871 | 12604787 | 4 | SS | TOVIAZ | FESOTERODINE FUMARATE | 1 | Unknown | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126047871 | 12604787 | 1 | Product used for unknown indication |
| 126047871 | 12604787 | 2 | Incontinence |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126047871 | 12604787 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126047871 | 12604787 | Cellulitis | |
| 126047871 | 12604787 | Drug ineffective | |
| 126047871 | 12604787 | Dry mouth |
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 |
|---|---|---|---|---|---|---|
| 126047871 | 12604787 | 3 | 2013 | 2014 | 0 | |
| 126047871 | 12604787 | 4 | 20150630 | 20150803 | 0 |