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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127055612 | 12705561 | 2 | F | 20160908 | 20160901 | 20160913 | EXP | US-ROCHE-1823404 | ROCHE | LIN N, FREEDMAN R, MILLER K, JHAVERI K, EIZNHAMER D, BERGER M, AND HAMILTON E DETERMINATION OF THE MAXIMUM TOLERATED DOSE (MTD) OF THE CNS PENETRANT TYROSINE KINASE INHIBITOR (TKI) TESEVATINIB ADMINISTERED IN COMBINATION WITH TRASTUZUMAB IN HER2+ PATIENTS WITH METASTATIC BREAST CANCER (BC) (ABSTRACT NUMBER: 514).. JOURNAL OF CLINICAL ONCOLOGY 2016 MAY;34 (SUP15):-. | 0.00 | Y | 0.00000 | 20160913 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127055612 | 12705561 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | U | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | ||||||
| 127055612 | 12705561 | 2 | SS | TESEVATINIB | TESEVATINIB | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127055612 | 12705561 | 1 | HER-2 positive breast cancer |
| 127055612 | 12705561 | 2 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127055612 | 12705561 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127055612 | 12705561 | Diarrhoea | |
| 127055612 | 12705561 | Electrocardiogram QT prolonged |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |