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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125664472 | 12566447 | 2 | F | 20081202 | 20160809 | 20160718 | 20160816 | EXP | PHHO2010ES022938 | NOVARTIS | 46.14 | YR | F | Y | 62.00000 | KG | 20160816 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125664472 | 12566447 | 1 | PS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 1500 MG, QD | Y | 22059 | 1500 | MG | TABLET | QD | |||||
| 125664472 | 12566447 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 80 MG/M2, QW | U | U | 0 | 80 | MG/M**2 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125664472 | 12566447 | 1 | Breast cancer |
| 125664472 | 12566447 | 2 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125664472 | 12566447 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125664472 | 12566447 | Alanine aminotransferase increased | |
| 125664472 | 12566447 | Hepatic lesion |
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 |
|---|---|---|---|---|---|---|
| 125664472 | 12566447 | 1 | 20081103 | 0 | ||
| 125664472 | 12566447 | 2 | 20081103 | 0 |