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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127576321 | 12757632 | 1 | I | 20160303 | 20160905 | 20160919 | 20160919 | EXP | 373169 | IT-ACCORD-043961 | ACCORD | 75.00 | YR | M | Y | 0.00000 | 20160919 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127576321 | 12757632 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | ALSO RECEIVED 708.9 MG CYCLICAL IV BOLUS ON 03-MAR-2016.??FOLFIRI | Y | 40743 | 4253 | MG | SOLUTION FOR INFUSION | ||||||
| 127576321 | 12757632 | 2 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | FOLFIRI | Y | 79068 | 319 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 127576321 | 12757632 | 3 | SS | AFLIBERCEPT | AFLIBERCEPT | 1 | Intravenous (not otherwise specified) | Y | 0 | 272 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 127576321 | 12757632 | 4 | SS | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | FOLFIRI | Y | 0 | 708.9 | MG | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127576321 | 12757632 | 1 | Colorectal cancer metastatic |
| 127576321 | 12757632 | 2 | Colorectal cancer metastatic |
| 127576321 | 12757632 | 3 | Colorectal cancer metastatic |
| 127576321 | 12757632 | 4 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127576321 | 12757632 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127576321 | 12757632 | Alopecia | |
| 127576321 | 12757632 | Asthenia | |
| 127576321 | 12757632 | Back pain | |
| 127576321 | 12757632 | Diarrhoea | |
| 127576321 | 12757632 | Dysphonia | |
| 127576321 | 12757632 | Leukopenia | |
| 127576321 | 12757632 | Nausea | |
| 127576321 | 12757632 | Rectal tenesmus |
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 |
|---|---|---|---|---|---|---|
| 127576321 | 12757632 | 1 | 20160303 | 0 | ||
| 127576321 | 12757632 | 2 | 20160303 | 20160303 | 0 | |
| 127576321 | 12757632 | 3 | 20160303 | 20160303 | 0 | |
| 127576321 | 12757632 | 4 | 20160303 | 20160303 | 0 |