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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125398671 | 12539867 | 1 | I | 20080623 | 20080627 | 20160708 | 20160708 | EXP | PHHO2008IE017198 | NOVARTIS | 44.79 | YR | F | Y | 67.20000 | KG | 20160708 | MD | IE | IE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125398671 | 12539867 | 1 | PS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 500 MG, QD | 366000 | MG | Y | 0 | 500 | MG | FILM-COATED TABLET | QD | |||
| 125398671 | 12539867 | 2 | SS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 0 MG, UNK | 366000 | MG | Y | 0 | FILM-COATED TABLET | ||||||
| 125398671 | 12539867 | 3 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 60 MG/M2, CYCLIC | Y | 0 | 60 | MG/M**2 | |||||||
| 125398671 | 12539867 | 4 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 2 MG/KG, QW | 2 | MG/KG | Y | 0 | 2 | MG/KG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125398671 | 12539867 | 1 | Breast cancer metastatic |
| 125398671 | 12539867 | 3 | Breast cancer metastatic |
| 125398671 | 12539867 | 4 | Breast cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125398671 | 12539867 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125398671 | 12539867 | Ejection fraction decreased |
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 |
|---|---|---|---|---|---|---|
| 125398671 | 12539867 | 1 | 20060623 | 20080716 | 0 | |
| 125398671 | 12539867 | 2 | 20080717 | 20080813 | 0 | |
| 125398671 | 12539867 | 3 | 20060623 | 0 | ||
| 125398671 | 12539867 | 4 | 20060623 | 20060623 | 0 |