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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 65968214 | 6596821 | 4 | F | 20040124 | 20160920 | 20080328 | 20160928 | PER | US-BAYER-US-2006-002355 | BAYER | 24.00 | YR | A | F | Y | 80.00000 | KG | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 65968214 | 6596821 | 1 | PS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | Y | 21225 | 20 | UG | INTRAUTERINE DELIVERY SYSTEM | ||||||
| 65968214 | 6596821 | 2 | SS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | Y | 41218C | 21225 | 20 | UG | INTRAUTERINE DELIVERY SYSTEM |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 65968214 | 6596821 | 1 | Contraception |
| 65968214 | 6596821 | 2 | Contraception |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 65968214 | 6596821 | OT |
| 65968214 | 6596821 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 65968214 | 6596821 | Anxiety | |
| 65968214 | 6596821 | Back pain | |
| 65968214 | 6596821 | Dehydration | |
| 65968214 | 6596821 | Depression | |
| 65968214 | 6596821 | Device expulsion | |
| 65968214 | 6596821 | Device issue | |
| 65968214 | 6596821 | Device use error | |
| 65968214 | 6596821 | Drug ineffective | |
| 65968214 | 6596821 | Intervertebral disc protrusion | |
| 65968214 | 6596821 | Medication error | |
| 65968214 | 6596821 | Pain | |
| 65968214 | 6596821 | Peritoneal adhesions | |
| 65968214 | 6596821 | Pregnancy with contraceptive device | |
| 65968214 | 6596821 | Uterine contractions during pregnancy | |
| 65968214 | 6596821 | Uterine perforation |
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 |
|---|---|---|---|---|---|---|
| 65968214 | 6596821 | 1 | 20030129 | 20060217 | 0 | |
| 65968214 | 6596821 | 2 | 20041229 | 20060217 | 0 |