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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127034621 | 12703462 | 1 | I | 201608 | 20160822 | 20160831 | 20160831 | PER | CN-BAYER-2016-163896 | BAYER | 50.00 | YR | A | F | Y | 0.00000 | 20160831 | CN | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127034621 | 12703462 | 1 | PS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | 21225 | 20 | UG | INTRAUTERINE DELIVERY SYSTEM | |||||||
| 127034621 | 12703462 | 2 | SS | MIRENA | LEVONORGESTREL | 1 | 21225 | INTRAUTERINE DELIVERY SYSTEM | |||||||||||
| 127034621 | 12703462 | 3 | SS | YASMIN | DROSPIRENONEETHINYL ESTRADIOL | 1 | Oral | UNK | 0 | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127034621 | 12703462 | 1 | Menorrhagia |
| 127034621 | 12703462 | 2 | Endometrial hyperplasia |
| 127034621 | 12703462 | 3 | Menstrual cycle management |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127034621 | 12703462 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127034621 | 12703462 | Constipation | |
| 127034621 | 12703462 | Off label use | |
| 127034621 | 12703462 | Postmenopausal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 127034621 | 12703462 | 1 | 20160820 | 0 | ||
| 127034621 | 12703462 | 3 | 201608 | 0 |