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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124983402 | 12498340 | 2 | F | 201605 | 20160718 | 20160627 | 20160721 | EXP | US-BAYER-2016-116399 | BAYER | 61.00 | YR | A | F | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124983402 | 12498340 | 1 | PS | CLIMARA PRO | ESTRADIOLLEVONORGESTREL | 1 | Transdermal | UNK | 150148 | 21258 | TRANSDERMAL PATCH | ||||||||
| 124983402 | 12498340 | 2 | SS | CLIMARA PRO | ESTRADIOLLEVONORGESTREL | 1 | 21258 | TRANSDERMAL PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124983402 | 12498340 | 1 | Hormone replacement therapy |
| 124983402 | 12498340 | 2 | Bone loss |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124983402 | 12498340 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124983402 | 12498340 | Application site erythema | |
| 124983402 | 12498340 | Application site irritation | |
| 124983402 | 12498340 | Application site pruritus | |
| 124983402 | 12498340 | Application site reaction | |
| 124983402 | 12498340 | Genital haemorrhage | |
| 124983402 | 12498340 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 124983402 | 12498340 | 1 | 20160522 | 0 |