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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125819201 | 12581920 | 1 | I | 20160708 | 20160722 | 20160722 | EXP | AU-CIPLA LTD.-2016AU09798 | CIPLA | SEGELOV E, THAVANESWARAN S, WARING PM, DESAI J, ROBLEDO KP, GEBSKI VJ ET AL.,. RESPONSE TO CETUXIMAB WITH OR WITHOUT IRINOTECAN IN PATIENTS WITH REFRACTORY METASTATIC COLORECTAL CANCER HARBORING THE KRAS G13D MUTATION: AUSTRALASIAN GASTRO-INTESTINAL TRIALS GROUP ICECREAM STUDY. JOURNAL OF CLINICAL ONCOLOGY. 2016;34:1 TO 9 | 0.00 | Y | 0.00000 | 20160722 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125819201 | 12581920 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK | 0 | ||||||||||
| 125819201 | 12581920 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2, ONCE EVERY TWO WEEKS | 0 | 180 | MG/M**2 | ||||||||
| 125819201 | 12581920 | 3 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | UNK | 0 | ||||||||||
| 125819201 | 12581920 | 4 | SS | Cetuximab | CETUXIMAB | 1 | Intravenous (not otherwise specified) | 400 MG/M2, LOADING DOSE | 0 | 400 | MG/M**2 | ||||||||
| 125819201 | 12581920 | 5 | SS | Cetuximab | CETUXIMAB | 1 | Intravenous (not otherwise specified) | 250 MG/M2, ONCE PER WEEK | 0 | 250 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125819201 | 12581920 | 1 | Colorectal cancer metastatic |
| 125819201 | 12581920 | 3 | Colorectal cancer metastatic |
| 125819201 | 12581920 | 4 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125819201 | 12581920 | DE |
| 125819201 | 12581920 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125819201 | 12581920 | Death | |
| 125819201 | 12581920 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |