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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125657871 | 12565787 | 1 | I | 20160630 | 20160714 | 20160718 | 20160718 | EXP | DE-ROCHE-1795211 | ROCHE | 53.00 | YR | F | Y | 68.00000 | KG | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125657871 | 12565787 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 02-JUN-2016 | U | N1049H02 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||
| 125657871 | 12565787 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 444 MG | U | N1049H02 | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | ||||
| 125657871 | 12565787 | 3 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE- 02/JUN/2016 | U | H0145H06 | 125409 | 840 | MG | SOLUTION FOR INFUSION | |||||
| 125657871 | 12565787 | 4 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | U | H0145H06 | 125409 | 420 | MG | SOLUTION FOR INFUSION | Q3W | |||||
| 125657871 | 12565787 | 5 | SS | LIPOSOMAL DOXORUBICIN | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 16-JUN-2016 | U | 15K41DE | 0 | 38 | MG | /wk | |||||
| 125657871 | 12565787 | 6 | SS | LIPOSOMAL DOXORUBICIN | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | DOSE REDUCED | U | 15K41DE | 0 | 28 | MG | /wk | |||||
| 125657871 | 12565787 | 7 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 16-JUN-2016 | U | FT6103 | 0 | 150 | MG | /wk | |||||
| 125657871 | 12565787 | 8 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | DOSE REDUCED | U | FT6103 | 0 | 113 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125657871 | 12565787 | 1 | Breast cancer |
| 125657871 | 12565787 | 3 | Breast cancer |
| 125657871 | 12565787 | 5 | Breast cancer |
| 125657871 | 12565787 | 7 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125657871 | 12565787 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125657871 | 12565787 | 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 |
|---|---|---|---|---|---|---|
| 125657871 | 12565787 | 1 | 20160218 | 0 | ||
| 125657871 | 12565787 | 3 | 20160218 | 0 | ||
| 125657871 | 12565787 | 5 | 20160218 | 201603 | 0 | |
| 125657871 | 12565787 | 6 | 20160331 | 0 | ||
| 125657871 | 12565787 | 7 | 20160218 | 0 | ||
| 125657871 | 12565787 | 8 | 20160331 | 201603 | 0 |