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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119173313 | 11917331 | 3 | F | 2014 | 20160812 | 20160114 | 20160822 | EXP | FI-BAYER-2015-490043 | BAYER | 41.00 | YR | A | F | Y | 0.00000 | 20160822 | CN | FI | FI |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119173313 | 11917331 | 1 | PS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | N | 21225 | INTRAUTERINE DELIVERY SYSTEM | ||||||||
| 119173313 | 11917331 | 2 | SS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | N | 21225 | INTRAUTERINE DELIVERY SYSTEM |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119173313 | 11917331 | 1 | Menorrhagia |
| 119173313 | 11917331 | 2 | Menorrhagia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119173313 | 11917331 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119173313 | 11917331 | Abdominal pain lower | |
| 119173313 | 11917331 | Amenorrhoea | |
| 119173313 | 11917331 | Back pain | |
| 119173313 | 11917331 | Cervical dysplasia | |
| 119173313 | 11917331 | Genital haemorrhage | |
| 119173313 | 11917331 | Hair growth abnormal | |
| 119173313 | 11917331 | Migraine | |
| 119173313 | 11917331 | Smear cervix normal | |
| 119173313 | 11917331 | Swelling | |
| 119173313 | 11917331 | Vaginal discharge | |
| 119173313 | 11917331 | Vaginal infection |
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 |
|---|---|---|---|---|---|---|
| 119173313 | 11917331 | 1 | 2013 | 2014 | 0 | |
| 119173313 | 11917331 | 2 | 201508 | 0 |