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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125391421 | 12539142 | 1 | I | 20160623 | 20160708 | 20160708 | EXP | BE-CIPLA LTD.-2016BE08873 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125391421 | 12539142 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK | U | U | 77219 | INJECTION | |||||||
| 125391421 | 12539142 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2 OVER 1 HOUR | U | U | 77219 | 180 | MG/M**2 | INJECTION | |||||
| 125391421 | 12539142 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2 | U | U | 0 | 400 | MG/M**2 | ||||||
| 125391421 | 12539142 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | 600 MG/M2 OVER 22 H ON DAYS 1 AND 2 | U | U | 0 | 600 | MG/M**2 | |||||||
| 125391421 | 12539142 | 5 | SS | Aflibercept | AFLIBERCEPT | 1 | Intravenous (not otherwise specified) | 5MG/KG ON DAY 1 | U | U | 0 | 5 | MG/KG | ||||||
| 125391421 | 12539142 | 6 | SS | LEUCOVRIN | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 200 MG/M2 OR 100MG/M2 OVER 2 HOURS200 MG/M2 OR 100MG/M2 OVER 2 HOURS | U | U | 0 | ||||||||
| 125391421 | 12539142 | 7 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125391421 | 12539142 | 1 | Neoplasm malignant |
| 125391421 | 12539142 | 3 | Neoplasm malignant |
| 125391421 | 12539142 | 5 | Neoplasm malignant |
| 125391421 | 12539142 | 6 | Neoplasm malignant |
| 125391421 | 12539142 | 7 | Neoplasm malignant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125391421 | 12539142 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125391421 | 12539142 | Incorrect drug administration rate | |
| 125391421 | 12539142 | Medication error | |
| 125391421 | 12539142 | Stomatitis | |
| 125391421 | 12539142 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |