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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125381622 | 12538162 | 2 | F | 20100604 | 20160722 | 20160707 | 20160726 | EXP | PHHO2010IE022561 | NOVARTIS | 56.50 | YR | F | Y | 48.30000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125381622 | 12538162 | 1 | PS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 1250 MG, QD | 2500 | MG | Y | 22059 | 1250 | MG | FILM-COATED TABLET | QD | |||
| 125381622 | 12538162 | 2 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 100 MG/M2, CYCLIC | Y | 0 | 100 | MG/M**2 | |||||||
| 125381622 | 12538162 | 3 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 4 MG/M2, QD | 4 | MG/M2 | Y | 0 | 4 | MG/M**2 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125381622 | 12538162 | 1 | Breast cancer metastatic |
| 125381622 | 12538162 | 2 | Breast cancer metastatic |
| 125381622 | 12538162 | 3 | Breast cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125381622 | 12538162 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125381622 | 12538162 | Colitis | |
| 125381622 | 12538162 | Fatigue |
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 |
|---|---|---|---|---|---|---|
| 125381622 | 12538162 | 1 | 20100603 | 20100609 | 0 | |
| 125381622 | 12538162 | 2 | 20100603 | 20160630 | 0 | |
| 125381622 | 12538162 | 3 | 20100603 | 20100603 | 0 |