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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125301221 | 12530122 | 1 | I | 20120424 | 20160706 | 20160706 | EXP | FR-CIPLA LTD.-2012FR00418 | CIPLA | MAZARD T, YCHOU M, THEZENAS, POUJOL S, PINGUET F, THIRION A, ET AL.. FEASIBILITY OF BIWEEKLY COMBINATION CHEMOTHERAPY WITH CAPECITABINE, IRINOTECAN, AND OXALIPLATIN IN PATIENTS WITH METASTATIC SOLID TUMORS: RESULTS OF A TWO-STEP PHASE I TRIAL: XELIRI AND XELIRINOX. CANCER CHEMOTHER PHARMACOL. 2012;69:807 TO 814 | 0.00 | A | Y | 0.00000 | 20160706 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125301221 | 12530122 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2, ON DAY 1, OVER 90 MIN, EVERY 2 WEEKS | U | U | 77219 | 180 | MG/M**2 | ||||||
| 125301221 | 12530122 | 2 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125301221 | 12530122 | 3 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 85 MG/M2, OVER 2 H ON DAY 1, EVERY 2 WEEKS | U | U | 0 | 85 | MG/M**2 | ||||||
| 125301221 | 12530122 | 4 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | 3500 MG/M2, BID, FROM 1 TO 7, EVERY 2 WEEKS | U | U | 0 | 3500 | MG/M**2 | ||||||
| 125301221 | 12530122 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | UNK | U | U | 0 | ||||||||
| 125301221 | 12530122 | 6 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125301221 | 12530122 | 1 | Neoplasm malignant |
| 125301221 | 12530122 | 2 | Neoplasm malignant |
| 125301221 | 12530122 | 3 | Neoplasm malignant |
| 125301221 | 12530122 | 4 | Neoplasm malignant |
| 125301221 | 12530122 | 5 | Neoplasm malignant |
| 125301221 | 12530122 | 6 | Neoplasm malignant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125301221 | 12530122 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125301221 | 12530122 | Diarrhoea | |
| 125301221 | 12530122 | Febrile neutropenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |