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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125665971 | 12566597 | 1 | I | 201602 | 20160617 | 20160718 | 20160718 | PER | US-MYLANLABS-2016M1025474 | MYLAN | 67.94 | YR | F | Y | 62.13000 | KG | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125665971 | 12566597 | 1 | PS | ESTRADIOL TRANSDERMAL SYSTEM | ESTRADIOL | 1 | Transdermal | 0.1 MG, QD, CHANGE TW | 615040 | 201675 | .1 | MG | TRANSDERMAL PATCH | QD | |||||
| 125665971 | 12566597 | 2 | C | TESTOSTERONE. | TESTOSTERONE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125665971 | 12566597 | 1 | Hormone replacement therapy |
| 125665971 | 12566597 | 2 | Hormone therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125665971 | 12566597 | Application site erythema | |
| 125665971 | 12566597 | Insomnia | |
| 125665971 | 12566597 | Irritability |
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 |
|---|---|---|---|---|---|---|
| 125665971 | 12566597 | 1 | 2014 | 0 |