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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122784383 | 12278438 | 3 | F | 20160629 | 20160418 | 20160707 | PER | US-BAYER-2016-071962 | BAYER | 0.00 | A | F | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122784383 | 12278438 | 1 | PS | CLIMARA PRO | ESTRADIOLLEVONORGESTREL | 1 | Transdermal | 1 (0.045 MG ESTRADIOL/ 0.015 LEVONORGESTREL) U, OW | 150148 | 21258 | 1 | IU | TRANSDERMAL PATCH | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122784383 | 12278438 | 1 | Hormone replacement therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122784383 | 12278438 | Application site irritation | |
| 122784383 | 12278438 | Incorrect dose administered by device | |
| 122784383 | 12278438 | Metrorrhagia | |
| 122784383 | 12278438 | Product adhesion issue | |
| 122784383 | 12278438 | Product physical issue | |
| 122784383 | 12278438 | Product shape issue | |
| 122784383 | 12278438 | Skin disorder | |
| 122784383 | 12278438 | Stress |
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 |
|---|---|---|---|---|---|---|
| 122784383 | 12278438 | 1 | 2013 | 0 |