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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126540144 | 12654014 | 4 | F | 20150915 | 20160912 | 20160816 | 20160922 | EXP | 369796 | IT-ACCORD-043086 | ACCORD | 54.00 | YR | F | Y | 78.00000 | KG | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126540144 | 12654014 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | RECEIVED INTRAVENOUS BOLUS SOLUTION FOR INFUSION 560 MG CYCLICAL FROM 21-JUL-2015 TO 05-MAY-2016 | 40743 | 3400 | MG | SOLUTION FOR INFUSION | |||||||
| 126540144 | 12654014 | 2 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 79068 | 250 | MG | SOLUTION FOR INFUSION | ||||||||
| 126540144 | 12654014 | 3 | SS | CETUXIMAB | CETUXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 340 | MG | SOLUTION FOR INFUSION | ||||||||
| 126540144 | 12654014 | 4 | C | LEDERFOLIN | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | 0 | 280 | MG | SOLUTION FOR INFUSION | ||||||||
| 126540144 | 12654014 | 5 | C | EUTIROX | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | 75 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126540144 | 12654014 | 1 | Adenocarcinoma of colon |
| 126540144 | 12654014 | 2 | Adenocarcinoma of colon |
| 126540144 | 12654014 | 3 | Adenocarcinoma of colon |
| 126540144 | 12654014 | 4 | Adenocarcinoma of colon |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126540144 | 12654014 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126540144 | 12654014 | Bladder spasm | |
| 126540144 | 12654014 | Chest pain | |
| 126540144 | 12654014 | Diarrhoea | |
| 126540144 | 12654014 | Irritable bowel syndrome | |
| 126540144 | 12654014 | Rash | |
| 126540144 | 12654014 | Skin lesion | |
| 126540144 | 12654014 | Strangury |
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 |
|---|---|---|---|---|---|---|
| 126540144 | 12654014 | 1 | 20150721 | 0 | ||
| 126540144 | 12654014 | 2 | 20150721 | 0 | ||
| 126540144 | 12654014 | 3 | 20150721 | 0 | ||
| 126540144 | 12654014 | 4 | 20150721 | 20160505 | 0 |