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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123347912 | 12334791 | 2 | F | 2013 | 20160630 | 20160504 | 20160713 | EXP | US-BAYER-2016-085782 | BAYER | 26.00 | YR | A | F | Y | 108.84000 | KG | 20160713 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123347912 | 12334791 | 1 | PS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | 74560R | 21225 | 20 | UG | INTRAUTERINE DELIVERY SYSTEM | ||||||
| 123347912 | 12334791 | 2 | SS | MIRENA | LEVONORGESTREL | 1 | 21225 | INTRAUTERINE DELIVERY SYSTEM | |||||||||||
| 123347912 | 12334791 | 3 | SS | MIRENA | LEVONORGESTREL | 1 | 21225 | INTRAUTERINE DELIVERY SYSTEM |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123347912 | 12334791 | 1 | Contraception |
| 123347912 | 12334791 | 2 | Menorrhagia |
| 123347912 | 12334791 | 3 | Dysmenorrhoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123347912 | 12334791 | HO |
| 123347912 | 12334791 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123347912 | 12334791 | Anxiety | |
| 123347912 | 12334791 | Depression | |
| 123347912 | 12334791 | Device issue | |
| 123347912 | 12334791 | Device use issue | |
| 123347912 | 12334791 | Drug ineffective | |
| 123347912 | 12334791 | Embedded device | |
| 123347912 | 12334791 | Emotional distress | |
| 123347912 | 12334791 | Habitual abortion | |
| 123347912 | 12334791 | Infertility female | |
| 123347912 | 12334791 | Maternal exposure before pregnancy |
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 |
|---|---|---|---|---|---|---|
| 123347912 | 12334791 | 1 | 20080527 | 20131108 | 0 |