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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104311596 | 10431159 | 6 | F | 201102 | 20160707 | 20140904 | 20160719 | PER | US-BAYER-2014-129517 | BAYER | 21.00 | YR | A | F | Y | 97.51000 | KG | 20160719 | LW | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104311596 | 10431159 | 1 | PS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | N | TU000KB | 21225 | 20 | UG | INTRAUTERINE DELIVERY SYSTEM | |||||
| 104311596 | 10431159 | 2 | SS | MIRENA | LEVONORGESTREL | 1 | N | 21225 | INTRAUTERINE DELIVERY SYSTEM | ||||||||||
| 104311596 | 10431159 | 3 | C | IRON [IRON] | IRON | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104311596 | 10431159 | 1 | Contraception |
| 104311596 | 10431159 | 2 | Menorrhagia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104311596 | 10431159 | DS |
| 104311596 | 10431159 | OT |
| 104311596 | 10431159 | LT |
| 104311596 | 10431159 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104311596 | 10431159 | Abdominal pain lower | |
| 104311596 | 10431159 | Abnormal weight gain | |
| 104311596 | 10431159 | Alopecia | |
| 104311596 | 10431159 | Blood iron decreased | |
| 104311596 | 10431159 | Complication of pregnancy | |
| 104311596 | 10431159 | Device difficult to use | |
| 104311596 | 10431159 | Device failure | |
| 104311596 | 10431159 | Device issue | |
| 104311596 | 10431159 | Fatigue | |
| 104311596 | 10431159 | Hypertension | |
| 104311596 | 10431159 | Injury | |
| 104311596 | 10431159 | Medical device discomfort | |
| 104311596 | 10431159 | Menstruation irregular | |
| 104311596 | 10431159 | Pain | |
| 104311596 | 10431159 | Peripheral swelling | |
| 104311596 | 10431159 | Post procedural haemorrhage | |
| 104311596 | 10431159 | Scar | |
| 104311596 | 10431159 | Syncope | |
| 104311596 | 10431159 | 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 |
|---|---|---|---|---|---|---|
| 104311596 | 10431159 | 1 | 20091228 | 20121016 | 0 |