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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126068151 | 12606815 | 1 | I | 20150528 | 20160729 | 20160729 | EXP | IT-SUN PHARMACEUTICAL INDUSTRIES LTD-2015R1-116185 | RANBAXY | BATTISTI S, GUIDA FM, PAGLIARA E, TONINI G, ZOBEL BB, SANTINI D. PSEUDOCIRRHOSIS AFTER ANTI-EGFR BASED NEOADJUVANT THERAPY FOR HEPATIC METASTASIS FROM COLON CANCER: A DIFFERENT POINT OF VIEW. CLIN COLORECTAL CANCER. 2014;13(3):E13-E15 | 69.00 | YR | M | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126068151 | 12606815 | 1 | SS | Calcium folinat | LEUCOVORIN CALCIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 126068151 | 12606815 | 2 | SS | Calcium folinat | LEUCOVORIN CALCIUM | 1 | U | 0 | |||||||||||
| 126068151 | 12606815 | 3 | PS | Irinotecan | IRINOTECAN | 1 | Unknown | 180MG/M2 ON DAY 1 | U | 78805 | |||||||||
| 126068151 | 12606815 | 4 | SS | Irinotecan | IRINOTECAN | 1 | U | 78805 | |||||||||||
| 126068151 | 12606815 | 5 | SS | Cetuximab | CETUXIMAB | 1 | Unknown | UNK | U | 0 | |||||||||
| 126068151 | 12606815 | 6 | SS | Cetuximab | CETUXIMAB | 1 | U | 0 | |||||||||||
| 126068151 | 12606815 | 7 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | UNK | U | 0 | INJECTION | ||||||||
| 126068151 | 12606815 | 8 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | U | 0 | INJECTION | ||||||||||
| 126068151 | 12606815 | 9 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | 600 MG/M2 ON DAY 1 AND 2 | U | 0 | INFUSION | ||||||||
| 126068151 | 12606815 | 10 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | U | 0 | INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126068151 | 12606815 | 1 | Adenocarcinoma of colon |
| 126068151 | 12606815 | 2 | Metastases to liver |
| 126068151 | 12606815 | 3 | Adenocarcinoma of colon |
| 126068151 | 12606815 | 4 | Metastases to liver |
| 126068151 | 12606815 | 5 | Adenocarcinoma of colon |
| 126068151 | 12606815 | 6 | Metastases to liver |
| 126068151 | 12606815 | 7 | Adenocarcinoma of colon |
| 126068151 | 12606815 | 8 | Metastases to liver |
| 126068151 | 12606815 | 9 | Adenocarcinoma of colon |
| 126068151 | 12606815 | 10 | Metastases to liver |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126068151 | 12606815 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126068151 | 12606815 | Diarrhoea | |
| 126068151 | 12606815 | Pseudocirrhosis | |
| 126068151 | 12606815 | Rash |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126068151 | 12606815 | 1 | 201201 | 0 | ||
| 126068151 | 12606815 | 3 | 201201 | 0 | ||
| 126068151 | 12606815 | 5 | 201201 | 0 |