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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127371851 | 12737185 | 1 | I | 20160827 | 20160830 | 20160913 | 20160913 | EXP | CA-ASTELLAS-2016US033845 | ASTELLAS | 59.46 | YR | F | Y | 0.00000 | 20160913 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127371851 | 12737185 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 3040 | MG | 203415 | 160 | MG | CAPSULE | QD | |||||
| 127371851 | 12737185 | 2 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 8 MG/KG, TOTAL SINGLE DOSE | N | 0 | 8 | MG/KG | FORMULATION UNKNOWN | ||||||
| 127371851 | 12737185 | 3 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 6 | MG/KG | FORMULATION UNKNOWN | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127371851 | 12737185 | 1 | Breast cancer |
| 127371851 | 12737185 | 2 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127371851 | 12737185 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127371851 | 12737185 | Embolism | |
| 127371851 | 12737185 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127371851 | 12737185 | 1 | 20160808 | 20160826 | 0 | |
| 127371851 | 12737185 | 2 | 20160808 | 0 |