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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125891231 | 12589123 | 1 | I | 20160211 | 20160715 | 20160725 | 20160725 | EXP | BR-BAYER-2016-139101 | BAYER | 29.00 | YR | A | F | Y | 0.00000 | 20160725 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125891231 | 12589123 | 1 | PS | YAZ | DROSPIRENONEETHINYL ESTRADIOL | 1 | Oral | 1 DF, QD | 21676 | 1 | DF | FILM-COATED TABLET | QD | ||||||
| 125891231 | 12589123 | 2 | SS | YAZ | DROSPIRENONEETHINYL ESTRADIOL | 1 | 21676 | FILM-COATED TABLET | |||||||||||
| 125891231 | 12589123 | 3 | SS | YAZ | DROSPIRENONEETHINYL ESTRADIOL | 1 | 21676 | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125891231 | 12589123 | 1 | Contraception |
| 125891231 | 12589123 | 2 | Endometriosis |
| 125891231 | 12589123 | 3 | Leiomyoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125891231 | 12589123 | HO |
| 125891231 | 12589123 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125891231 | 12589123 | Focal nodular hyperplasia | |
| 125891231 | 12589123 | Nephrolithiasis | |
| 125891231 | 12589123 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125891231 | 12589123 | 1 | 2016 | 0 |