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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125405702 | 12540570 | 2 | F | 2015 | 20160727 | 20160708 | 20160803 | EXP | IT-ROCHE-1784063 | ROCHE | 55.57 | YR | F | Y | 75.00000 | KG | 20160803 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125405702 | 12540570 | 1 | PS | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | 1 | Intravenous (not otherwise specified) | VIAL, TOTAL: 270 MG | B0002B01,B0003B05,N1022B05,N1022B06 | 125427 | 3.6 | MG/KG | |||||||
| 125405702 | 12540570 | 2 | SS | PERJETA | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION, 30 MG/ML - 1 VIAL | Y | H0082B03 | 125409 | 840 | MG | ||||||
| 125405702 | 12540570 | 3 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | VIAL, POWDER FOR CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION | Y | N1027B01 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||
| 125405702 | 12540570 | 4 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Unknown | 103792 | |||||||||||
| 125405702 | 12540570 | 5 | SS | TAXOTERE | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 160 MG/8 ML CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION | Y | 4F148A | 0 | 75 | MG/M**2 | QD | |||||
| 125405702 | 12540570 | 6 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 0 | |||||||||||
| 125405702 | 12540570 | 7 | C | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | FEC THERAPY | 0 | ||||||||||
| 125405702 | 12540570 | 8 | C | EPIRUBICIN | EPIRUBICIN | 1 | Unknown | FEC THERAPY | 0 | ||||||||||
| 125405702 | 12540570 | 9 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | FEC THERAPY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125405702 | 12540570 | 1 | HER-2 positive breast cancer |
| 125405702 | 12540570 | 2 | HER-2 positive breast cancer |
| 125405702 | 12540570 | 3 | HER-2 positive breast cancer |
| 125405702 | 12540570 | 4 | HER-2 positive breast cancer |
| 125405702 | 12540570 | 5 | HER-2 positive breast cancer |
| 125405702 | 12540570 | 6 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125405702 | 12540570 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125405702 | 12540570 | Alanine aminotransferase increased | |
| 125405702 | 12540570 | Asthenia | |
| 125405702 | 12540570 | Disease recurrence | |
| 125405702 | 12540570 | Nail bed disorder | |
| 125405702 | 12540570 | Neurotoxicity | |
| 125405702 | 12540570 | 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 |
|---|---|---|---|---|---|---|
| 125405702 | 12540570 | 1 | 20160126 | 20160718 | 0 | |
| 125405702 | 12540570 | 2 | 20150410 | 20151026 | 0 | |
| 125405702 | 12540570 | 3 | 20150410 | 20151026 | 0 | |
| 125405702 | 12540570 | 4 | 2013 | 201401 | 0 | |
| 125405702 | 12540570 | 5 | 20150410 | 20150731 | 0 | |
| 125405702 | 12540570 | 6 | 2013 | 0 |