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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115196162 | 11519616 | 2 | F | 20160627 | 20150918 | 20160705 | EXP | US-ROCHE-1633839 | ROCHE | , LIN N, RICHARDSON A, LESHCHINER I, MAYER I, FORERO-TORRES A, HOBDAY T, DEES E, NANDA R, RIMAWI M, GUO H, BARRY W, BOSE R, SHEN W, WOLFF A, GABRIEL S, GARRAWAY L, WINER E AND KROP I. WHOLE-EXOME SEQUENCING (WES) OF HER2+ METASTATIC BREAST CANCER (MBC) FROM PATIENTS (PTS) TREATED WITH OR WITHOUT PRIOR TRASTUZUMAB (T): A CORRELATIVE ANALYSIS OF TBCRC003. CANCER RESEARCH 2015 MAY 01;75(9 SUP1):-. | 0.00 | F | Y | 0.00000 | 20160705 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115196162 | 11519616 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | U | 103792 | 4 | MG/KG | SOLUTION FOR INFUSION | ||||||
| 115196162 | 11519616 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 2 MG/KG (FOLLOWING A 4-MG/KG LOADING DOSE) | U | 103792 | 2 | MG/KG | SOLUTION FOR INFUSION | /wk | |||||
| 115196162 | 11519616 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE CHANGED FOR PATIENTS ENROLLED FROM JUL/2009 | U | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | ||||||
| 115196162 | 11519616 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 6 MG/KG (AFTER AN 8-MG/KG LOADING DOSE) MAINTENANCE DOSE CHANGED FOR PATIENTS ENROLLED FROM JUL/2009 | U | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | |||||
| 115196162 | 11519616 | 5 | SS | LAPATINIB | LAPATINIB | 1 | Oral | U | 0 | 1000 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115196162 | 11519616 | 1 | HER-2 positive breast cancer |
| 115196162 | 11519616 | 5 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115196162 | 11519616 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115196162 | 11519616 | Diarrhoea | |
| 115196162 | 11519616 | Fatigue | |
| 115196162 | 11519616 | Gastrointestinal disorder | |
| 115196162 | 11519616 | Hypokalaemia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |