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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124078443 | 12407844 | 3 | F | 20160504 | 20160708 | 20160526 | 20160715 | PER | US-BAYER-2016-100980 | BAYER | 31.00 | YR | A | F | Y | 68.27000 | KG | 20160715 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124078443 | 12407844 | 1 | PS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | TU00NXA | 21225 | INTRAUTERINE DELIVERY SYSTEM | ||||||||
| 124078443 | 12407844 | 2 | SS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | TU0166J | 21225 | INTRAUTERINE DELIVERY SYSTEM | ||||||||
| 124078443 | 12407844 | 3 | SS | MIRENA | LEVONORGESTREL | 1 | Intra-uterine | 20 MCG/24HR, CONT | 21225 | 20 | UG | INTRAUTERINE DELIVERY SYSTEM | |||||||
| 124078443 | 12407844 | 4 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 124078443 | 12407844 | 5 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | 0 | |||||||||||
| 124078443 | 12407844 | 6 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124078443 | 12407844 | 1 | Contraception |
| 124078443 | 12407844 | 2 | Contraception |
| 124078443 | 12407844 | 3 | Contraception |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124078443 | 12407844 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124078443 | 12407844 | Abdominal pain lower | |
| 124078443 | 12407844 | Back pain | |
| 124078443 | 12407844 | Chills | |
| 124078443 | 12407844 | Device dislocation | |
| 124078443 | 12407844 | Device expulsion | |
| 124078443 | 12407844 | Dyspareunia | |
| 124078443 | 12407844 | Gait disturbance | |
| 124078443 | 12407844 | Genital haemorrhage | |
| 124078443 | 12407844 | Metrorrhagia | |
| 124078443 | 12407844 | Nausea | |
| 124078443 | 12407844 | Ovarian cyst | |
| 124078443 | 12407844 | Pelvic pain | |
| 124078443 | 12407844 | Procedural pain | |
| 124078443 | 12407844 | Pyrexia | |
| 124078443 | 12407844 | Uterine tenderness | |
| 124078443 | 12407844 | Vaginal haemorrhage | |
| 124078443 | 12407844 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 124078443 | 12407844 | 1 | 20131210 | 20160504 | 0 | |
| 124078443 | 12407844 | 2 | 20160504 | 20160523 | 0 | |
| 124078443 | 12407844 | 3 | 20160523 | 0 |