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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126628851 | 12662885 | 1 | I | 20160805 | 20160818 | 20160818 | EXP | IT-CIPLA LTD.-2016IT17072 | CIPLA | GRANDE R, GEMMA D, SPERDUTI I, GELIBTER A, GIAMPAOLO M, TROMBETTA G ET AL.,. CHANGING MONOCLONAL ANTIBODY KEEPING UNALTERED THE CHEMOTHERAPY REGIMEN IN METASTATIC COLORECTAL CANCER PATIENTS: IS EFFICACY MAINTAINED. SPRINGERPLUS. 2013;2 (185):1 TO 6 | 0.00 | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126628851 | 12662885 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2,OVER 90 MINUTES ON DAY 1,CONCURRENTLY WITH FOLINIC ACID | U | U | 77219 | 180 | MG/M**2 | ||||||
| 126628851 | 12662885 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2,ON DAYS 1 AND 2 | U | U | 0 | 400 | MG/M**2 | ||||||
| 126628851 | 12662885 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 1200 MG/M2, INFUSION, DIE OVER 46 HOURS | U | U | 0 | 1200 | MG/M**2 | QD | |||||
| 126628851 | 12662885 | 4 | SS | Folinic acid | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 100 MG/M2,ON DAY 1 AND 2, OVER 120 MINUTES | U | U | 0 | 100 | MG/M**2 | ||||||
| 126628851 | 12662885 | 5 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | 5 MG/KG, ON DAY 1, EVERY 2 WEEKS | U | 0 | 5 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126628851 | 12662885 | 1 | Colorectal cancer metastatic |
| 126628851 | 12662885 | 2 | Colorectal cancer metastatic |
| 126628851 | 12662885 | 4 | Colorectal cancer metastatic |
| 126628851 | 12662885 | 5 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126628851 | 12662885 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126628851 | 12662885 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |