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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393341 | 12539334 | 1 | I | 20130305 | 20160708 | 20160708 | EXP | BE-CIPLA LTD.-2013BE00746 | CIPLA | CUTSEM EV, KHAYAT D, VERSLYPE C, BILLEMONT B, TEJPAR S, MERIC JB, ET AL. PHASE I DOSE-ESCALATION STUDY OF INTRAVENOUS AFLIBERCEPT ADMINISTERED IN COMBINATION WITH IRINOTECAN, 5-FLUOROURACIL AND LEUCOVORIN IN PATIENTS WITH ADVANCED SOLID TUMOURS. EUROPEAN JOURNAL OF CANCER. 2013;49:17 TO 24 | 0.00 | Y | 0.00000 | 20160708 | OT | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393341 | 12539334 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK, PRIOR THERAPY | Y | U | 0 | ||||||||
| 125393341 | 12539334 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2 OVER 1 H, EVERY TWO WEEKS | Y | U | 0 | 180 | MG/M**2 | ||||||
| 125393341 | 12539334 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2 BOLUS ON DAYS 1 AND 2, EVERY TWO WEEKS | Y | U | 0 | 400 | MG/M**2 | INFUSION | |||||
| 125393341 | 12539334 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | 600 MG/M2, OVER 22 H ON DAYS 1 AND 2, EVERY TWO WEEKS | Y | U | 0 | 600 | MG/M**2 | INFUSION | ||||||
| 125393341 | 12539334 | 5 | SS | AFILBERCEPT | AFLIBERCEPT | 1 | Intravenous (not otherwise specified) | 4 MG/KG, OVER 1 H ON DAY 1, EVERY TWO WEEKS | Y | U | 0 | 4 | MG/KG | ||||||
| 125393341 | 12539334 | 6 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | 200 MG/M2 OR 100MG/M2 OVER 2 HOURS | Y | U | 0 | ||||||||
| 125393341 | 12539334 | 7 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125393341 | 12539334 | 1 | Neoplasm malignant |
| 125393341 | 12539334 | 3 | Neoplasm malignant |
| 125393341 | 12539334 | 5 | Neoplasm malignant |
| 125393341 | 12539334 | 6 | Neoplasm malignant |
| 125393341 | 12539334 | 7 | Neoplasm malignant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125393341 | 12539334 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125393341 | 12539334 | Hypertension | |
| 125393341 | 12539334 | Nephrotic syndrome | |
| 125393341 | 12539334 | Thrombotic microangiopathy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |