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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125666071 | 12566607 | 1 | I | 2015 | 20160531 | 20160718 | 20160718 | PER | US-MYLANLABS-2016M1022902 | MYLAN | 0.00 | F | Y | 54.42000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125666071 | 12566607 | 1 | PS | ESTRADIOL TRANSDERMAL SYSTEM | ESTRADIOL | 1 | Transdermal | 0.037 MG, QD (TW) | Y | Y | 201675 | .037 | MG | TRANSDERMAL PATCH | QD | ||||
| 125666071 | 12566607 | 2 | SS | ESTRADIOL TRANSDERMAL SYSTEM | ESTRADIOL | 1 | Transdermal | 0.037 MG, QD (TW) | Y | Y | 201675 | .037 | MG | TRANSDERMAL PATCH | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125666071 | 12566607 | 1 | Hormone replacement therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125666071 | 12566607 | Abdominal discomfort | |
| 125666071 | 12566607 | Drug effect decreased | |
| 125666071 | 12566607 | Muscle spasms |
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 |
|---|---|---|---|---|---|---|
| 125666071 | 12566607 | 1 | 2015 | 2015 | 0 | |
| 125666071 | 12566607 | 2 | 201601 | 201605 | 0 |