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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124168132 | 12416813 | 2 | F | 20160707 | 20160530 | 20160713 | PER | PHEH2016US012610 | NOVARTIS | 0.00 | F | Y | 81.60000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124168132 | 12416813 | 1 | PS | ESTRADIOL. | ESTRADIOL | 1 | Transdermal | 0.075 MG, QD | Y | U | 19081 | .075 | MG | PATCH | QD | ||||
| 124168132 | 12416813 | 2 | SS | ESTRADIOL. | ESTRADIOL | 1 | Transdermal | UNK UNK, QW2 | Y | U | 19081 | PATCH | BIW | ||||||
| 124168132 | 12416813 | 3 | SS | ESTRADIOL. | ESTRADIOL | 1 | UNK | Y | U | 19081 | PATCH | ||||||||
| 124168132 | 12416813 | 4 | C | VAGIFEM | ESTRADIOL | 1 | Unknown | 10 UG, UNK | U | 0 | 10 | UG | Q3W | ||||||
| 124168132 | 12416813 | 5 | C | MULTI VIT | 2 | Unknown | U | 0 | |||||||||||
| 124168132 | 12416813 | 6 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 124168132 | 12416813 | 7 | C | MOTRIN | IBUPROFEN | 1 | Unknown | UNK UNK, PRN | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124168132 | 12416813 | 1 | Menopause |
| 124168132 | 12416813 | 4 | Product used for unknown indication |
| 124168132 | 12416813 | 5 | Product used for unknown indication |
| 124168132 | 12416813 | 6 | Product used for unknown indication |
| 124168132 | 12416813 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124168132 | 12416813 | Breast pain | |
| 124168132 | 12416813 | Dermal absorption impaired | |
| 124168132 | 12416813 | Drug ineffective | |
| 124168132 | 12416813 | Hot flush | |
| 124168132 | 12416813 | Incorrect drug administration rate |
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 |
|---|---|---|---|---|---|---|
| 124168132 | 12416813 | 2 | 201603 | 20160518 | 0 |