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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126246392 | 12624639 | 2 | F | 20160306 | 20160810 | 20160805 | 20160812 | EXP | NL-ROCHE-1806320 | ROCHE | 48.98 | YR | F | Y | 0.00000 | 20160812 | MD | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126246392 | 12624639 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||||
| 126246392 | 12624639 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 6 MG/KG MAINTENACE DOSE?MOST RECENT DOSE OF TRASTUZUMAB ON 16/FEB/2016 D1 (D8-D15) | 103792 | 600 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 126246392 | 12624639 | 3 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | 125409 | 840 | MG | SOLUTION FOR INFUSION | |||||||
| 126246392 | 12624639 | 4 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE OF PERTUZUMAB ON 16/FEB/2016?MAINTENANCE DOSE | 125409 | 420 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 126246392 | 12624639 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE OF PACLITAXEL (160 MG) ON 23/FEB/2016 D1(D8) | 0 | 80 | MG/M**2 | SOLUTION FOR INFUSION | |||||||
| 126246392 | 12624639 | 6 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC 6 | 0 | 160 | MG | SOLUTION FOR INFUSION | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126246392 | 12624639 | 1 | HER-2 positive breast cancer |
| 126246392 | 12624639 | 3 | HER-2 positive breast cancer |
| 126246392 | 12624639 | 5 | HER-2 positive breast cancer |
| 126246392 | 12624639 | 6 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126246392 | 12624639 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126246392 | 12624639 | Pneumonitis |
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 |
|---|---|---|---|---|---|---|
| 126246392 | 12624639 | 1 | 20151215 | 0 | ||
| 126246392 | 12624639 | 3 | 20151215 | 0 | ||
| 126246392 | 12624639 | 5 | 20151215 | 0 | ||
| 126246392 | 12624639 | 6 | 20151215 | 0 |