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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126468761 | 12646876 | 1 | I | 20160808 | 20160812 | 20160812 | EXP | IT-ROCHE-1811258 | ROCHE | PIZZUTI L, BARBA M, GIANNARELLI D, SERGI D, BOTTI C, MARCHETTI P, ANZA M, MAUGERI-SACCA M, NATOLI C, DI FILIPPO S, CATENARO T, TOMAO F, AMODIO A, CARPANO S, PERRACCHIO L, MOTTOLESE M, DI LAURO L, SANGUINETI G, DI BENEDETTO A, GIORDANO A AND VICI P. NEOADJUVANT SEQUENTIAL DOCETAXEL FOLLOWED BY HIGH-DOSE EPIRUBICIN IN COMBINATION WITH CYCLOPHOSPHAMIDE ADMINISTERED CONCURRENTLY WITH TRASTUZUMAB. THE DECT TRIAL. JOURNAL OF CELLULAR PHYSIOLOGY 2016;231 (11):2541-2547. | 0.00 | F | Y | 0.00000 | 20160812 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126468761 | 12646876 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | U | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | ||||||
| 126468761 | 12646876 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTENANCE DOSE | U | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | |||||
| 126468761 | 12646876 | 3 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | U | 0 | 100 | MG/M**2 | ||||||||
| 126468761 | 12646876 | 4 | SS | EPIRUBICIN | EPIRUBICIN | 1 | Unknown | U | 0 | 120 | MG/M**2 | ||||||||
| 126468761 | 12646876 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | 600 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126468761 | 12646876 | 1 | HER-2 positive breast cancer |
| 126468761 | 12646876 | 3 | HER-2 positive breast cancer |
| 126468761 | 12646876 | 4 | HER-2 positive breast cancer |
| 126468761 | 12646876 | 5 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126468761 | 12646876 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126468761 | 12646876 | Anaemia | |
| 126468761 | 12646876 | Ejection fraction decreased | |
| 126468761 | 12646876 | Febrile neutropenia | |
| 126468761 | 12646876 | Leukopenia | |
| 126468761 | 12646876 | Mucosal inflammation | |
| 126468761 | 12646876 | Myalgia | |
| 126468761 | 12646876 | Nausea | |
| 126468761 | 12646876 | Neurotoxicity | |
| 126468761 | 12646876 | Neutropenia | |
| 126468761 | 12646876 | Transaminases increased | |
| 126468761 | 12646876 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |