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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125433532 | 12543353 | 2 | F | 20160630 | 20160722 | 20160711 | 20160727 | EXP | DE-ROCHE-1788482 | ROCHE | 53.00 | YR | F | Y | 68.00000 | KG | 20160727 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125433532 | 12543353 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | U | N1049H02 | 125409 | 840 | MG | SOLUTION FOR INFUSION | |||||
| 125433532 | 12543353 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTENENCE DOSE?THE MOST RECENT DOSE PRIOR YO SAE ON 02/JUN/2016 | U | N1049H02 | 125409 | 420 | MG | INFUSION | Q3W | ||||
| 125433532 | 12543353 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | U | N1049H02 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||
| 125433532 | 12543353 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTENENCE DOSE?THE MOST RECENT DOSE PRIOR TO SAE ON 23/JUN/2016 | U | N1049H02 | 103792 | 444 | MG/KG | SOLUTION FOR INFUSION | Q3W | ||||
| 125433532 | 12543353 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | THE MOST RECENT DOSE PRIOR TO SAE ON 16/JUN/2016 | U | FT6103 | 0 | 150 | MG | INFUSION | |||||
| 125433532 | 12543353 | 6 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | DOSE REDUCED | U | FT6103 | 0 | 113 | MG | INFUSION | |||||
| 125433532 | 12543353 | 7 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | THE MOST RECENT DOSE PRIOR SAE ON 16/JUN/2016 | U | 15K41DE | 0 | 38 | MG | INFUSION | |||||
| 125433532 | 12543353 | 8 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | DOSE REDUCED | U | 15K41DE | 0 | 28 | MG | INFUSION | |||||
| 125433532 | 12543353 | 9 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 125433532 | 12543353 | 10 | C | BLEOMYCIN | BLEOMYCIN SULFATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125433532 | 12543353 | 1 | Breast cancer |
| 125433532 | 12543353 | 3 | Breast cancer |
| 125433532 | 12543353 | 5 | Breast cancer |
| 125433532 | 12543353 | 7 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125433532 | 12543353 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125433532 | 12543353 | 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 |
|---|---|---|---|---|---|---|
| 125433532 | 12543353 | 1 | 20160218 | 0 | ||
| 125433532 | 12543353 | 3 | 20160218 | 0 | ||
| 125433532 | 12543353 | 5 | 20160218 | 0 | ||
| 125433532 | 12543353 | 6 | 20160331 | 0 | ||
| 125433532 | 12543353 | 7 | 20160218 | 0 | ||
| 125433532 | 12543353 | 8 | 20160331 | 0 |