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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126998291 | 12699829 | 1 | I | 20160823 | 20160830 | 20160830 | EXP | BE-MYLANLABS-2016M1036595 | MYLAN | IGNATIADIS M, ZARDAVAS D, LEMORT M, WILKE C, VANDERBEEKEN M-C, D^HONDT V, ET AL. FEASIBILITY STUDY OF ENDOTAG-1, A TUMOR ENDOTHELIAL TARGETING AGENT, IN COMBINATION WITH PACLITAXEL FOLLOWED BY FEC AS INDUCTION THERAPY IN HER2-NEGATIVE BREAST CANCER. PLOS-ONE 2016;11:NO. 7. | 0.00 | Y | 0.00000 | 20160830 | OT | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126998291 | 12699829 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | 500MG/M2 EVERY 3 WEEKS | U | U | 202668 | ||||||||
| 126998291 | 12699829 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous drip | 70 MG/M2 WEEKLY | U | 0 | |||||||||
| 126998291 | 12699829 | 3 | SS | EPIRUBICIN | EPIRUBICIN | 1 | Unknown | 100MG/M2 EVERY 3 WEEKS | U | U | 0 | ||||||||
| 126998291 | 12699829 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 500MG/M2 EVERY 3 WEEKS | U | U | 0 | ||||||||
| 126998291 | 12699829 | 5 | SS | INVESTIGATIONAL ANTINEOPLASTIC DRUGS | INVESTIGATIONAL PRODUCT | 1 | Intravenous drip | 22 MG/M2 WEEKLY | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126998291 | 12699829 | 1 | Breast cancer |
| 126998291 | 12699829 | 2 | Breast cancer |
| 126998291 | 12699829 | 3 | Breast cancer |
| 126998291 | 12699829 | 4 | Breast cancer |
| 126998291 | 12699829 | 5 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126998291 | 12699829 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126998291 | 12699829 | Drug hypersensitivity | |
| 126998291 | 12699829 | Neutropenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |