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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125644821 | 12564482 | 1 | I | 2011 | 20160705 | 20160718 | 20160718 | PER | PHHY2016US097661 | NOVARTIS | 48.00 | YR | F | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125644821 | 12564482 | 1 | SS | COMBIPATCH | ESTRADIOLNORETHINDRONE ACETATE | 1 | Transdermal | UNK (50 MG ESTRADIOL, 250 MG NORETHINDRONE ACETATE) | 0 | MATRIX TRANS THERAPEUTIC SYST. | |||||||||
| 125644821 | 12564482 | 2 | SS | COMBIPATCH | ESTRADIOLNORETHINDRONE ACETATE | 1 | 0 | MATRIX TRANS THERAPEUTIC SYST. | |||||||||||
| 125644821 | 12564482 | 3 | SS | COMBIPATCH | ESTRADIOLNORETHINDRONE ACETATE | 1 | 0 | MATRIX TRANS THERAPEUTIC SYST. | |||||||||||
| 125644821 | 12564482 | 4 | PS | CLIMARA | ESTRADIOL | 1 | Unknown | UNK | 19081 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125644821 | 12564482 | 1 | Hot flush |
| 125644821 | 12564482 | 2 | Night sweats |
| 125644821 | 12564482 | 3 | Hormone replacement therapy |
| 125644821 | 12564482 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125644821 | 12564482 | Abdominal pain upper | |
| 125644821 | 12564482 | Dry mouth | |
| 125644821 | 12564482 | Frequent bowel movements | |
| 125644821 | 12564482 | Insomnia | |
| 125644821 | 12564482 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125644821 | 12564482 | 1 | 2011 | 201606 | 0 | |
| 125644821 | 12564482 | 4 | 201606 | 0 |