Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4715611 | 5844973 | I | 4715611-3 | 20050601 | 20050630 | 20050713 | EXP | FI-2005-012316 | BERLEX INC. | 52 | YR | F | N | 64 | KG | 20050712 | MD | FINLAND |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4715611 | 1006213632 | PS | MIRENA | 1 | INTRA-UTERINE | 20 UG/DAY, CONT, INTRA-UTERINE | N | D | 21225 | ||
| 4715611 | 1006244895 | SS | CLIMARA | 1 | TRANSDERMAL | 50 UG, CONT, TRASDERMAL | U | U | |||
| 4715611 | 1006244901 | SS | ESTRADIOL VALERATE | 1 | ORAL | 2 MG, ORAL | U | U |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4715611 | 1006213632 | CONTRACEPTION |
| 4715611 | 1006244895 | HORMONE REPLACEMENT THERAPY |
| 4715611 | 1006244901 | HORMONE REPLACEMENT THERAPY |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4715611 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 4715611 | BREAST CANCER FEMALE |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4715611 | FGN |
| 4715611 | HP |
| 4715611 | OTH |
| 4715611 | SDY |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4715611 | 1006213632 | 20030609 | 20050627 | ||
| 4715611 | 1006244895 | 20040920 | 20050323 | ||
| 4715611 | 1006244901 | 20050320 | 20050619 |