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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125300961 | 12530096 | 1 | I | 20111227 | 20160706 | 20160706 | EXP | FR-CIPLA LTD.-2012FR00025 | CIPLA | DAHAN L, CICCOLINI J, EVRARD A, MBATCHI L, TIBBITTS J, RIES P ET AL.,. SUDDEN DEATH RELATED TO TOXICITY IN A PATIENT ON CAPECITABINE AND IRINOTECAN PLUS BEVACIZUMAB INTAKE: PHARMACOGENETIC IMPLICATIONS. JOURNAL OF CLINICAL ONCOLOGY. 2012;30 (4):E41 TO E44 | 57.00 | YR | M | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125300961 | 12530096 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK | U | U | 77219 | ||||||||
| 125300961 | 12530096 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | 200 MG/M2, ON DAYS 1 AND 21, TOTAL DOSE 400 MG | U | U | 77219 | 200 | MG/M**2 | ||||||
| 125300961 | 12530096 | 3 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | UNK, STANDARD ADJUVANT THERAPY | U | U | 0 | INJECTION | |||||||
| 125300961 | 12530096 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | UNK, STANDARD ADJUVANT THERAPY | U | U | 0 | INJECTION | ||||||||
| 125300961 | 12530096 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | UNK | U | U | 0 | INJECTION | ||||||||
| 125300961 | 12530096 | 6 | SS | CAPECITABINE. | CAPECITABINE | 1 | Unknown | 1000 MG/M2, BID, FROM DAYS 1 TO 14 (TOTAL DOSE 3500 MG/DAY) | U | 0 | 1000 | MG/M**2 | |||||||
| 125300961 | 12530096 | 7 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | UNK, STANDARD ADJUVANT THERAPY | U | U | 0 | ||||||||
| 125300961 | 12530096 | 8 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125300961 | 12530096 | 9 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125300961 | 12530096 | 10 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | 7.5 MG/KG, ON DAYS 1 TO 21, (775 MG) | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125300961 | 12530096 | 1 | Colorectal cancer metastatic |
| 125300961 | 12530096 | 2 | Metastasis |
| 125300961 | 12530096 | 3 | Colorectal cancer metastatic |
| 125300961 | 12530096 | 6 | Colorectal cancer metastatic |
| 125300961 | 12530096 | 7 | Colorectal cancer metastatic |
| 125300961 | 12530096 | 9 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125300961 | 12530096 | OT |
| 125300961 | 12530096 | HO |
| 125300961 | 12530096 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125300961 | 12530096 | Condition aggravated | |
| 125300961 | 12530096 | Diarrhoea | |
| 125300961 | 12530096 | Metastases to liver | |
| 125300961 | 12530096 | Metastases to lung | |
| 125300961 | 12530096 | Neutropenia | |
| 125300961 | 12530096 | Sepsis | |
| 125300961 | 12530096 | Skin reaction |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |