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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126401041 | 12640104 | 1 | I | 20110717 | 20110719 | 20160810 | 20160810 | EXP | PHHO2011GB024627 | NOVARTIS | 45.02 | YR | F | Y | 79.10000 | KG | 20160810 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126401041 | 12640104 | 1 | PS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 1250 MG, QD | Y | Y | 22059 | 1250 | MG | FILM-COATED TABLET | QD | ||||
| 126401041 | 12640104 | 2 | SS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 1000 MG, QD | Y | Y | 22059 | 1000 | MG | FILM-COATED TABLET | QD | ||||
| 126401041 | 12640104 | 3 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | 2000 MG/M2, CYCLIC | 0 | 2000 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126401041 | 12640104 | 1 | Breast cancer metastatic |
| 126401041 | 12640104 | 3 | Breast cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126401041 | 12640104 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126401041 | 12640104 | Rash | |
| 126401041 | 12640104 | Viral infection | Viral infection |
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 |
|---|---|---|---|---|---|---|
| 126401041 | 12640104 | 1 | 20110630 | 0 | ||
| 126401041 | 12640104 | 2 | 20110717 | 0 | ||
| 126401041 | 12640104 | 3 | 20110630 | 0 |