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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125192103 | 12519210 | 3 | F | 20160826 | 20160630 | 20160829 | PER | US-BAYER-2016-124004 | BAYER | 58.00 | YR | A | F | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125192103 | 12519210 | 1 | PS | CLIMARA PRO | ESTRADIOLLEVONORGESTREL | 1 | Transdermal | UNK | 21258 | TRANSDERMAL PATCH | |||||||||
| 125192103 | 12519210 | 2 | SS | CLIMARA PRO | ESTRADIOLLEVONORGESTREL | 1 | Transdermal | UNK | 21258 | TRANSDERMAL PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125192103 | 12519210 | 1 | Hormone replacement therapy |
| 125192103 | 12519210 | 2 | Hormone replacement therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125192103 | 12519210 | Application site dermatitis | |
| 125192103 | 12519210 | Application site erythema | |
| 125192103 | 12519210 | Condition aggravated | |
| 125192103 | 12519210 | Device material issue | |
| 125192103 | 12519210 | Drug ineffective | |
| 125192103 | 12519210 | Fungal skin infection | |
| 125192103 | 12519210 | Hot flush | |
| 125192103 | 12519210 | Product adhesion issue | |
| 125192103 | 12519210 | Product quality issue | |
| 125192103 | 12519210 | Skin warm |
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 |
|---|---|---|---|---|---|---|
| 125192103 | 12519210 | 1 | 2015 | 0 | ||
| 125192103 | 12519210 | 2 | 201506 | 0 |