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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125664491 | 12566449 | 1 | I | 20080814 | 20080815 | 20160718 | 20160718 | EXP | PHHO2008CN018227 | NOVARTIS | 39.99 | YR | F | Y | 56.00000 | KG | 20160718 | MD | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125664491 | 12566449 | 1 | PS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 1000 MG, QD | 85000 | MG | Y | 22059 | 1000 | MG | TABLET | QD | |||
| 125664491 | 12566449 | 2 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125664491 | 12566449 | 1 | Breast cancer |
| 125664491 | 12566449 | 2 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125664491 | 12566449 | HO |
| 125664491 | 12566449 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125664491 | 12566449 | Alanine aminotransferase increased | |
| 125664491 | 12566449 | Aspartate aminotransferase increased | |
| 125664491 | 12566449 | Autoimmune hepatitis | |
| 125664491 | 12566449 | Biliary cirrhosis primary | |
| 125664491 | 12566449 | Drug-induced liver injury | |
| 125664491 | 12566449 | Jaundice |
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 |
|---|---|---|---|---|---|---|
| 125664491 | 12566449 | 1 | 20080523 | 20080815 | 0 | |
| 125664491 | 12566449 | 2 | 20080523 | 20090514 | 0 |