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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126760101 | 12676010 | 1 | I | 200004 | 20160810 | 20160823 | 20160823 | EXP | DE-CIPLA LTD.-2016DE17417 | CIPLA | 0.00 | Y | 0.00000 | 20160823 | OT | US | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126760101 | 12676010 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Unknown | 50 MG/M2, (80 MG TOTAL) WEEKLY | U | U | 77219 | 50 | MG/M**2 | ||||||
| 126760101 | 12676010 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | 80 MG/M2, (140 MG TOTAL) WEEKLY | U | U | 77219 | 80 | MG/M**2 | ||||||
| 126760101 | 12676010 | 3 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | 100 MG/M2, (180 MG TOTAL) WEEKLY | U | U | 77219 | 100 | MG/M**2 | ||||||
| 126760101 | 12676010 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | UNK | U | 0 | |||||||||
| 126760101 | 12676010 | 5 | SS | Folinic acid | LEUCOVORIN | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126760101 | 12676010 | 1 | Colorectal cancer stage III |
| 126760101 | 12676010 | 4 | Colorectal cancer stage III |
| 126760101 | 12676010 | 5 | Colorectal cancer stage III |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126760101 | 12676010 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126760101 | 12676010 | Diarrhoea | |
| 126760101 | 12676010 | Disease progression | |
| 126760101 | 12676010 | Gastrointestinal toxicity | |
| 126760101 | 12676010 | Metastases to liver |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |