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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126274051 | 12627405 | 1 | I | 2015 | 20160727 | 20160805 | 20160805 | EXP | IT-SA-2016SA138053 | AVENTIS | 54.00 | YR | A | F | Y | 64.00000 | KG | 20160805 | CN | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126274051 | 12627405 | 1 | PS | TAXOTERE | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 160MG/8ML CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION | Y | 4F148A | 20449 | 75 | MG/M**2 | CONCENTRATE FOR SOLUTION FOR INFUSION | /cycle | ||||
| 126274051 | 12627405 | 2 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Unknown | STOP DATE: 2015 | Y | UNKNOWN | 0 | ||||||||
| 126274051 | 12627405 | 3 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 150MG CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION | Y | N1027B01 | 0 | 6 | MG/KG | CONCENTRATE FOR SOLUTION FOR INFUSION | /cycle | ||||
| 126274051 | 12627405 | 4 | SS | PERJETA | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | 420MG CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION | Y | H0082B03 | 0 | 840 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /cycle | ||||
| 126274051 | 12627405 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 126274051 | 12627405 | 6 | SS | TRASTUZUMAB EMTANSINE | ADO-TRASTUZUMAB EMTANSINE | 1 | Unknown | 0 | 3.6 | MG/KG | SOLUTION FOR INFUSION | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126274051 | 12627405 | 1 | Breast cancer metastatic |
| 126274051 | 12627405 | 2 | Breast cancer metastatic |
| 126274051 | 12627405 | 3 | Breast cancer metastatic |
| 126274051 | 12627405 | 4 | Breast cancer metastatic |
| 126274051 | 12627405 | 5 | Breast cancer |
| 126274051 | 12627405 | 6 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126274051 | 12627405 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126274051 | 12627405 | Alanine aminotransferase increased | |
| 126274051 | 12627405 | Asthenia | |
| 126274051 | 12627405 | Disease recurrence | |
| 126274051 | 12627405 | Nail bed disorder | |
| 126274051 | 12627405 | Neurotoxicity | |
| 126274051 | 12627405 | Paraesthesia |
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 |
|---|---|---|---|---|---|---|
| 126274051 | 12627405 | 1 | 20150410 | 20150731 | 0 | |
| 126274051 | 12627405 | 2 | 2013 | 201401 | 0 | |
| 126274051 | 12627405 | 3 | 20150410 | 20151026 | 0 | |
| 126274051 | 12627405 | 4 | 20150410 | 20151026 | 0 | |
| 126274051 | 12627405 | 5 | 2013 | 0 | ||
| 126274051 | 12627405 | 6 | 201601 | 0 |