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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124761172 | 12476117 | 2 | F | 20160711 | 20160617 | 20160720 | EXP | US-ROCHE-1770591 | ROCHE | UNKNOWN. THE FLEXIBILITY OF CONVENTIONAL THERAPIES.. UPDATE ONCOLOGY AND HAEMATOLOGY 2016;:10-. | 0.00 | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124761172 | 12476117 | 1 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | 0 | |||||||||||
| 124761172 | 12476117 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 0 | |||||||||||
| 124761172 | 12476117 | 3 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | 1X | ||||||
| 124761172 | 12476117 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | OVER 30 MINUTES: MAINTAINANCE DOSE | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | ||||||
| 124761172 | 12476117 | 5 | SS | MYL-1401O (TRASTUZUMAB BIOSIMILAR) | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG/KG | 1X | ||||||||
| 124761172 | 12476117 | 6 | SS | MYL-1401O (TRASTUZUMAB BIOSIMILAR) | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | 0 | 6 | MG/KG | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124761172 | 12476117 | 1 | HER-2 positive breast cancer |
| 124761172 | 12476117 | 2 | HER-2 positive breast cancer |
| 124761172 | 12476117 | 3 | HER-2 positive breast cancer |
| 124761172 | 12476117 | 5 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124761172 | 12476117 | DE |
| 124761172 | 12476117 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124761172 | 12476117 | Death | |
| 124761172 | 12476117 | Neutropenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |