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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125462891 | 12546289 | 1 | I | 201403 | 20160704 | 20160711 | 20160711 | EXP | GR-BAXTER-2016BAX036292 | BAXTER | 52.45 | YR | F | Y | 0.00000 | 20160711 | MD | GR | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125462891 | 12546289 | 1 | PS | ENDOXAN 1000 MG - POWDER FOR SOLUTION FOR INJECTION | CYCLOPHOSPHAMIDE | 1 | Unknown | THREE CYCLES, FEC100 | U | 12142 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 125462891 | 12546289 | 2 | SS | NAVELBINE | VINORELBINE TARTRATE | 1 | Unknown | REGIMEN #1 | U | 0 | SOLUTION FOR INJECTION | /cycle | |||||||
| 125462891 | 12546289 | 3 | SS | NAVELBINE | VINORELBINE TARTRATE | 1 | U | 0 | |||||||||||
| 125462891 | 12546289 | 4 | SS | EXEMESTANE. | EXEMESTANE | 1 | Unknown | REGIMEN #1, FOR SIX MONTHS | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 5 | SS | epirubicin HCL | EPIRUBICIN HYDROCHLORIDE | 1 | Unknown | THREE CYCLES OF FEC100 | U | 0 | |||||||||
| 125462891 | 12546289 | 6 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | THREE CYCLES, 100 UNIT NOT REPORTED | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 7 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | REGIMEN #1, SIX CYCLE | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 8 | SS | PACLITAXEL. | PACLITAXEL | 1 | U | 0 | |||||||||||
| 125462891 | 12546289 | 9 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | Unknown | REGIMEN#1 | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 10 | SS | GEMCITABINE HYDROCHLORIDE. | GEMCITABINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125462891 | 12546289 | 11 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | THREE CYCLES, FEC100 | U | 0 | |||||||||
| 125462891 | 12546289 | 12 | SS | LETROZOLE. | LETROZOLE | 1 | Unknown | REGIMEN #1 | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 13 | SS | everolimus | EVEROLIMUS | 1 | Unknown | REGIMEN #1, FOR 6 MONTHS | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 14 | SS | fulvestrant | FULVESTRANT | 1 | Unknown | REGIMEN #1 | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 15 | SS | fulvestrant | FULVESTRANT | 1 | U | 0 | |||||||||||
| 125462891 | 12546289 | 16 | SS | denosumab | DENOSUMAB | 1 | Unknown | REGIMEN #1 | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 17 | SS | denosumab | DENOSUMAB | 1 | U | 0 | |||||||||||
| 125462891 | 12546289 | 18 | SS | bevacizumab | BEVACIZUMAB | 1 | Unknown | REGIMEN #1, SIX CYCLE | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 19 | SS | bevacizumab | BEVACIZUMAB | 1 | Unknown | MAINTENANCE | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 20 | SS | Caelyx | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | REGIMEN #1 | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 21 | SS | Caelyx | DOXORUBICIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125462891 | 12546289 | 22 | SS | eribulin | ERIBULIN | 1 | Unknown | REGIMEN #1 | U | 0 | /cycle | ||||||||
| 125462891 | 12546289 | 23 | SS | eribulin | ERIBULIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125462891 | 12546289 | 1 | Breast cancer metastatic |
| 125462891 | 12546289 | 2 | Breast cancer metastatic |
| 125462891 | 12546289 | 3 | Malignant neoplasm progression |
| 125462891 | 12546289 | 4 | Breast cancer metastatic |
| 125462891 | 12546289 | 5 | Breast cancer metastatic |
| 125462891 | 12546289 | 6 | Breast cancer metastatic |
| 125462891 | 12546289 | 7 | Breast cancer metastatic |
| 125462891 | 12546289 | 8 | Metastases to liver |
| 125462891 | 12546289 | 9 | Breast cancer metastatic |
| 125462891 | 12546289 | 10 | Malignant neoplasm progression |
| 125462891 | 12546289 | 11 | Breast cancer metastatic |
| 125462891 | 12546289 | 12 | Breast cancer metastatic |
| 125462891 | 12546289 | 13 | Breast cancer metastatic |
| 125462891 | 12546289 | 14 | Breast cancer metastatic |
| 125462891 | 12546289 | 15 | Metastases to bone |
| 125462891 | 12546289 | 16 | Breast cancer metastatic |
| 125462891 | 12546289 | 17 | Metastases to bone |
| 125462891 | 12546289 | 18 | Breast cancer metastatic |
| 125462891 | 12546289 | 19 | Metastases to liver |
| 125462891 | 12546289 | 20 | Breast cancer metastatic |
| 125462891 | 12546289 | 21 | Malignant neoplasm progression |
| 125462891 | 12546289 | 22 | Breast cancer metastatic |
| 125462891 | 12546289 | 23 | Malignant neoplasm progression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125462891 | 12546289 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125462891 | 12546289 | Disease progression | |
| 125462891 | 12546289 | Metastases to bone | |
| 125462891 | 12546289 | Metastases to liver | |
| 125462891 | 12546289 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 125462891 | 12546289 | 19 | 201409 | 201501 | 0 |