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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123166492 | 12316649 | 2 | F | 20160803 | 20160429 | 20160812 | EXP | FR-ROCHE-1748505 | ROCHE | CHIBAUDEL B, MAINDRAULT-GOBEL F, BACHET J-B, LOUVET C, KHALIL A, DUPUIS O, HAMMEL P, GARCIA M-L, BENNAMOUN M, BRUSQUANT D, TOURNIGAND C, ANDRE T, ARBAUD C, LARSEN A, WANG Y-W, YEH C, BONNETAIN F AND DE GRAMONT A. PEPCOL: A GERCOR RANDOMIZED PHASE II STUDY OF NANOLIPOSOMAL IRINOTECAN PEP02 (MM-398) OR IRINOTECAN WITH LEUCOVORIN/5-FLUOROURACIL AS SECOND-LINE THERAPY IN METASTATIC COLORECTAL CANCER. CANCER MEDICINE 2016 APR 01;5 (4):676-683. | 0.00 | Y | 0.00000 | 20160812 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123166492 | 12316649 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | U | 125085 | 5 | MG/KG | SOLUTION FOR INFUSION | |||||||
| 123166492 | 12316649 | 2 | SS | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | OVER 2- H | U | 0 | 400 | MG/M**2 | |||||||
| 123166492 | 12316649 | 3 | SS | 5-FLUOROURACIL | FLUOROURACIL | 1 | Unknown | 5- FU(5- FLUOROURACIL) 2400 MG/ M2 CONTINUOUS INFUSION OVER 46- H IN FUPEP ARM; IN REGIMEN OF FOLFIR | U | 0 | INFUSION | ||||||||
| 123166492 | 12316649 | 4 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | IN FOLFIRI- 1 ARM, IRINOTECAN 180 MG/ M2 IV OVER 90 MIN; IN FOLFIRI- 3 ARM, IRINOTECAN 90 MG/M2 AS 1 | U | 0 | |||||||||
| 123166492 | 12316649 | 5 | SS | PEP02 | IRINOTECAN SUCROSOFATE | 1 | Intravenous (not otherwise specified) | OVE 90 MIN | U | 0 | 80 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123166492 | 12316649 | 1 | Colorectal cancer metastatic |
| 123166492 | 12316649 | 2 | Colorectal cancer metastatic |
| 123166492 | 12316649 | 3 | Colorectal cancer metastatic |
| 123166492 | 12316649 | 4 | Colorectal cancer metastatic |
| 123166492 | 12316649 | 5 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123166492 | 12316649 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123166492 | 12316649 | Anaemia | |
| 123166492 | 12316649 | Diarrhoea | |
| 123166492 | 12316649 | Nausea | |
| 123166492 | 12316649 | Neutropenia | |
| 123166492 | 12316649 | Stomatitis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |