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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116483244 | 11648324 | 4 | F | 2013 | 20160719 | 20151021 | 20160727 | PER | US-BAYER-2015-447042 | BAYER | 31.00 | YR | A | F | Y | 63.00000 | KG | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116483244 | 11648324 | 1 | PS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | Y | 21225 | 20 | UG | INTRAUTERINE DELIVERY SYSTEM | ||||||
| 116483244 | 11648324 | 2 | SS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | Y | 21225 | 20 | UG | INTRAUTERINE DELIVERY SYSTEM |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116483244 | 11648324 | 1 | Contraception |
| 116483244 | 11648324 | 2 | Contraception |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116483244 | 11648324 | HO |
| 116483244 | 11648324 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116483244 | 11648324 | Abdominal pain lower | |
| 116483244 | 11648324 | Back pain | |
| 116483244 | 11648324 | Device dislocation | |
| 116483244 | 11648324 | Genital haemorrhage | |
| 116483244 | 11648324 | Headache | |
| 116483244 | 11648324 | Hypoaesthesia | |
| 116483244 | 11648324 | Nausea | |
| 116483244 | 11648324 | Neck pain | |
| 116483244 | 11648324 | Paraesthesia | |
| 116483244 | 11648324 | Scar | |
| 116483244 | 11648324 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 116483244 | 11648324 | 1 | 201109 | 0 | ||
| 116483244 | 11648324 | 2 | 20130613 | 20131213 | 0 |