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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124915235 | 12491523 | 5 | F | 20160823 | 20160623 | 20160826 | EXP | PHEH2016US015433 | NOVARTIS | 0.00 | F | Y | 86.00000 | KG | 20160826 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124915235 | 12491523 | 1 | PS | VIVELLE-DOT | ESTRADIOL | 1 | Transdermal | UNK | N | 20538 | TRANS-THERAPEUTIC-SYSTEM | ||||||||
| 124915235 | 12491523 | 2 | SS | VIVELLE-DOT | ESTRADIOL | 1 | N | 20538 | TRANS-THERAPEUTIC-SYSTEM | ||||||||||
| 124915235 | 12491523 | 3 | SS | VIVELLE-DOT | ESTRADIOL | 1 | N | 20538 | TRANS-THERAPEUTIC-SYSTEM | ||||||||||
| 124915235 | 12491523 | 4 | SS | ESTRADIOL. | ESTRADIOL | 1 | Transdermal | 0.05 MG, UNK | N | 69512 | 0 | .05 | MG | PATCH | |||||
| 124915235 | 12491523 | 5 | C | XANAX | ALPRAZOLAM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124915235 | 12491523 | 1 | Thrombosis |
| 124915235 | 12491523 | 2 | Haemorrhage |
| 124915235 | 12491523 | 3 | Menopausal symptoms |
| 124915235 | 12491523 | 4 | Product used for unknown indication |
| 124915235 | 12491523 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124915235 | 12491523 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124915235 | 12491523 | Postmenopausal haemorrhage | |
| 124915235 | 12491523 | Thrombosis | |
| 124915235 | 12491523 | Uterine leiomyoma | |
| 124915235 | 12491523 | Vaginal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 124915235 | 12491523 | 1 | 2012 | 20150324 | 0 |