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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126132416 | 12613241 | 6 | F | 20150305 | 20160905 | 20160802 | 20160913 | EXP | 368033 | IT-ACCORD-042748 | ACCORD | 77.00 | YR | M | Y | 69.00000 | KG | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126132416 | 12613241 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | ALSO RECEIVED 720 MG CYCLICAL BY INTRAVENOUS BOLUS?575(I.V.BOLUS),3455 MG I.V.,11-FEB TO 13-MAY-201 | 40743 | 4320 | MG | SOLUTION FOR INFUSION | |||||||
| 126132416 | 12613241 | 2 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | ALSO RECEIVED AT THE DOSE OF 250 MGFROM 11-FEB-2016 TO 13-MAY-2016 | 79068 | 320 | MG | SOLUTION FOR INFUSION | |||||||
| 126132416 | 12613241 | 3 | SS | AVASTIN | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | ALSO RECEIVED FROM 11-FEB-2016 TO 13-MAY-2016 | 0 | 340 | MG | SOLUTION FOR INFUSION | |||||||
| 126132416 | 12613241 | 4 | C | Lederfolin | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | ALSO RECEIVED AT THE DOSE OF 280 MG FROM 11-FEB-2016 TO 13-MAY-2016 | 0 | 360 | MG | SOLUTION FOR INFUSION | |||||||
| 126132416 | 12613241 | 5 | C | Acequide | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126132416 | 12613241 | 1 | Rectal adenocarcinoma |
| 126132416 | 12613241 | 2 | Rectal adenocarcinoma |
| 126132416 | 12613241 | 3 | Rectal adenocarcinoma |
| 126132416 | 12613241 | 4 | Rectal adenocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126132416 | 12613241 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126132416 | 12613241 | Abdominal pain | |
| 126132416 | 12613241 | Anaemia | |
| 126132416 | 12613241 | Cardiotoxicity | |
| 126132416 | 12613241 | Diarrhoea | |
| 126132416 | 12613241 | Dry skin | |
| 126132416 | 12613241 | Hyperglycaemia | |
| 126132416 | 12613241 | Mucosal inflammation | |
| 126132416 | 12613241 | Neutropenia | |
| 126132416 | 12613241 | Paraesthesia | |
| 126132416 | 12613241 | Skin hyperpigmentation | |
| 126132416 | 12613241 | 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 |
|---|---|---|---|---|---|---|
| 126132416 | 12613241 | 1 | 20150210 | 0 | ||
| 126132416 | 12613241 | 2 | 20150210 | 0 | ||
| 126132416 | 12613241 | 3 | 20150210 | 0 | ||
| 126132416 | 12613241 | 4 | 20150210 | 20150728 | 0 |