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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125559211 | 12555921 | 1 | I | 20160630 | 20160704 | 20160714 | 20160714 | EXP | DE-TEVA-676351GER | TEVA | 53.00 | YR | F | Y | 68.00000 | KG | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125559211 | 12555921 | 1 | SS | Myocet | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 16-JUN-2016 | U | 15K41DE | 0 | 28 | MG | SOLUTION FOR INFUSION | /wk | ||||
| 125559211 | 12555921 | 2 | SS | Myocet | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | U | 15K41DE | 0 | 38 | MG | SOLUTION FOR INFUSION | /wk | |||||
| 125559211 | 12555921 | 3 | PS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 16-JUN-2016 | U | FT6103 | 75297 | 113 | MG | SOLUTION FOR INFUSION | /wk | ||||
| 125559211 | 12555921 | 4 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | U | FT6103 | 75297 | 150 | MG | SOLUTION FOR INFUSION | /wk | |||||
| 125559211 | 12555921 | 5 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 02-JUN-2016 | U | H0145H06 | 0 | 420 | MG | SOLUTION FOR INFUSION | Q3W | ||||
| 125559211 | 12555921 | 6 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 02-JUN-2016 | U | N1049H02 | 0 | 444 | MG | SOLUTION FOR INFUSION | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125559211 | 12555921 | 1 | Breast cancer female |
| 125559211 | 12555921 | 3 | Breast cancer female |
| 125559211 | 12555921 | 5 | Breast cancer female |
| 125559211 | 12555921 | 6 | Breast cancer female |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125559211 | 12555921 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125559211 | 12555921 | 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 |
|---|---|---|---|---|---|---|
| 125559211 | 12555921 | 1 | 20160331 | 0 | ||
| 125559211 | 12555921 | 2 | 20160218 | 201603 | 0 | |
| 125559211 | 12555921 | 3 | 20160331 | 201603 | 0 | |
| 125559211 | 12555921 | 4 | 20160218 | 0 | ||
| 125559211 | 12555921 | 5 | 20160218 | 0 | ||
| 125559211 | 12555921 | 6 | 20160218 | 0 |