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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125750211 | 12575021 | 1 | I | 20151111 | 20151112 | 20160720 | 20160720 | PER | US-ASTELLAS-2015US042409 | ASTELLAS | 70.03 | YR | F | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125750211 | 12575021 | 1 | PS | VESICARE | SOLIFENACIN SUCCINATE | 1 | Unknown | Y | 21518 | 5 | MG | TABLET | QD | ||||||
| 125750211 | 12575021 | 2 | SS | VESICARE | SOLIFENACIN SUCCINATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | Y | 21518 | TABLET | |||||||
| 125750211 | 12575021 | 3 | C | DIOVAN HCT | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125750211 | 12575021 | 1 | Product used for unknown indication |
| 125750211 | 12575021 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125750211 | 12575021 | Chromaturia | Chromaturia |
| 125750211 | 12575021 | Dyspepsia | Dyspepsia |
| 125750211 | 12575021 | Mouth swelling | |
| 125750211 | 12575021 | Treatment noncompliance | |
| 125750211 | 12575021 | Vaginal discharge | Vaginal discharge |
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 |
|---|---|---|---|---|---|---|
| 125750211 | 12575021 | 1 | 201510 | 0 | ||
| 125750211 | 12575021 | 2 | 20151108 | 0 |