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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125424731 | 12542473 | 1 | I | 20160624 | 20160709 | 20160709 | EXP | FR-CIPLA LTD.-2016FR08934 | CIPLA | ASSAF E, VERLINDE-CARVALHO M, DELBALDO C, GRENIER J, SELLAM Z, POUESSEL D, ET.AL,. 5-FLUOROURACIL/LEUCOVORIN COMBINED WITH IRINOTECAN AND OXALIPLATIN (FOLFIRINOX) AS SECOND-LINE CHEMOTHERAPY IN PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA.. ONCOLOGY. 2011;80:301 TO 306 | 0.00 | Y | 0.00000 | 20160709 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125424731 | 12542473 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125424731 | 12542473 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2, 90 MINUTE INFUSION | U | U | 0 | 180 | MG/M**2 | INFUSION | |||||
| 125424731 | 12542473 | 3 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 85 MG/M2, 2 HOUR INFUSION | U | U | 0 | 85 | MG/M**2 | INFUSION | |||||
| 125424731 | 12542473 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 400 MG/M2, AS BOLUS | U | U | 0 | 400 | MG/M**2 | INFUSION | |||||
| 125424731 | 12542473 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 2400 MG/M2, 46 HOURS CONTINUOUS INFUSION | U | U | 0 | 2400 | MG/M**2 | INFUSION | |||||
| 125424731 | 12542473 | 6 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 400 MG/M2, OVER 2 HOURS INFUSION | U | U | 0 | 400 | MG/M**2 | ||||||
| 125424731 | 12542473 | 7 | C | ATROPINE. | ATROPINE | 1 | Subcutaneous | 0.25 MG, UNK | U | U | 0 | .25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125424731 | 12542473 | 1 | Pancreatic carcinoma metastatic |
| 125424731 | 12542473 | 2 | Pancreatic carcinoma metastatic |
| 125424731 | 12542473 | 3 | Pancreatic carcinoma metastatic |
| 125424731 | 12542473 | 4 | Pancreatic carcinoma metastatic |
| 125424731 | 12542473 | 6 | Pancreatic carcinoma metastatic |
| 125424731 | 12542473 | 7 | Cholangiocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125424731 | 12542473 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125424731 | 12542473 | Disease progression | |
| 125424731 | 12542473 | Haemolysis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |