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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125297172 | 12529717 | 2 | F | 20160114 | 20160704 | 20160706 | 20160712 | EXP | 364668 | IT-ACCORD-042074 | ACCORD | 71.00 | YR | M | Y | 68.00000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125297172 | 12529717 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | ALSO RECEIVED IV BOLUS AT DOSE OF 700 MG CYCLICAL | 40743 | 4300 | MG | SOLUTION FOR INFUSION | |||||||
| 125297172 | 12529717 | 2 | SS | ERBITUX | CETUXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 330 | MG | SOLUTION FOR INFUSION | ||||||||
| 125297172 | 12529717 | 3 | C | Lederfolin | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | 0 | 350 | MG | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125297172 | 12529717 | 1 | Adenocarcinoma of colon |
| 125297172 | 12529717 | 2 | Adenocarcinoma of colon |
| 125297172 | 12529717 | 3 | Adenocarcinoma of colon |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125297172 | 12529717 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125297172 | 12529717 | Constipation | |
| 125297172 | 12529717 | Paraesthesia | |
| 125297172 | 12529717 | Rash | |
| 125297172 | 12529717 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 125297172 | 12529717 | 1 | 20150723 | 0 | ||
| 125297172 | 12529717 | 2 | 20150723 | 0 | ||
| 125297172 | 12529717 | 3 | 20150723 | 20160526 | 0 |