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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125433501 | 12543350 | 1 | I | 20160222 | 20160702 | 20160711 | 20160711 | EXP | US-ROCHE-1789372 | ROCHE | 50.00 | YR | F | Y | 115.00000 | KG | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125433501 | 12543350 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | OVER 60 MIN ON DAY 1, (CYCLE 1), LAST DOSE PRIOR TO SAE 18/FEB/2016 | 125409 | 840 | MG | ||||||||
| 125433501 | 12543350 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | OVER 30-60 MIN ON DAY 1 (CYCLE 2-6) | 125409 | 420 | MG | ||||||||
| 125433501 | 12543350 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | OVER 90 MIN ON DAY 1 (CYCLE 1), LAST DOSE PRIOR TO SAE 18/FEB/2016 | 103792 | 8 | MG/KG | ||||||||
| 125433501 | 12543350 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | OVER 30-60 MIN ON DAY 1, (CYCLE 2-6) | 103792 | 6 | MG/KG | ||||||||
| 125433501 | 12543350 | 5 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | OVER 60 MIN ON DAY 1 (CYCLE 1, CYCLE 2-6), LAST DOSE PRIOR TO SAE 18/FEB/2016 | Y | 0 | 75 | MG/M**2 | |||||||
| 125433501 | 12543350 | 6 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC=6 MG/ML/MIN, OVER 30-60 MIN ON DAY 1, (CYCLE 1, CYCLE 2-6), LAST DOSE PRIOR TO SAE 18/FEB/2016 | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125433501 | 12543350 | 1 | HER-2 positive breast cancer |
| 125433501 | 12543350 | 3 | HER-2 positive breast cancer |
| 125433501 | 12543350 | 5 | HER-2 positive breast cancer |
| 125433501 | 12543350 | 6 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125433501 | 12543350 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125433501 | 12543350 | Dehydration |
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 |
|---|---|---|---|---|---|---|
| 125433501 | 12543350 | 1 | 20160105 | 0 | ||
| 125433501 | 12543350 | 3 | 20160105 | 0 | ||
| 125433501 | 12543350 | 5 | 20160105 | 0 | ||
| 125433501 | 12543350 | 6 | 20160105 | 0 |