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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123978472 | 12397847 | 2 | F | 20160829 | 20160524 | 20160831 | EXP | IT-ROCHE-1763055 | ROCHE | ANTONIOTTI C, NI G, GARATTINI S, MASI G, BATTAGLIN F, LUCCHESI S, SALVATORE L, CORSI D, DI FABIO F, BANZI M, SENSI E, TOMCIKOVA D, FONTANINI G, ZAGONEL V , BONI L AND FALCONE A. MODIFIED FOLFOXIRI (MFOLFOXIRI) PLUS CETUXIMAB (CET), FOLLOWED BY CET OR BEVACIZUMAB (BEV) MAINTENANCE, IN RAS/BRAF WILD-TYPE (WT) METASTATIC COLORECTAL CANCER (MCRC): RESULTS OF THE PHASE II RANDOMIZED MACBETH TRIAL BY GONO. JOURNAL OF CLINICAL ONCOLOGY 2016 MAY;34 (SUP15):-. | 0.00 | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123978472 | 12397847 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | U | 125085 | BIW | |||||||||
| 123978472 | 12397847 | 2 | SS | CETUXIMAB | CETUXIMAB | 1 | Unknown | U | 0 | 500 | MG/M**2 | BIW | |||||||
| 123978472 | 12397847 | 3 | SS | IRINOTECAN | IRINOTECAN | 1 | Unknown | U | 0 | 130 | MG/M**2 | BIW | |||||||
| 123978472 | 12397847 | 4 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | U | 0 | 85 | MG/M**2 | BIW | |||||||
| 123978472 | 12397847 | 5 | SS | L-LEUCOVORIN | LEUCOVORIN | 1 | Unknown | U | 0 | 200 | MG/M**2 | BIW | |||||||
| 123978472 | 12397847 | 6 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | U | 0 | 2400 | MG/M**2 | INFUSION | BIW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123978472 | 12397847 | 1 | Colorectal cancer metastatic |
| 123978472 | 12397847 | 2 | Colorectal cancer metastatic |
| 123978472 | 12397847 | 3 | Colorectal cancer metastatic |
| 123978472 | 12397847 | 4 | Colorectal cancer metastatic |
| 123978472 | 12397847 | 5 | Colorectal cancer metastatic |
| 123978472 | 12397847 | 6 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123978472 | 12397847 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123978472 | 12397847 | Diarrhoea | |
| 123978472 | 12397847 | Febrile neutropenia | |
| 123978472 | 12397847 | Neurotoxicity | |
| 123978472 | 12397847 | Neutropenia | |
| 123978472 | 12397847 | Rash | |
| 123978472 | 12397847 | Stomatitis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |