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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126430231 | 12643023 | 1 | I | 200511 | 20160805 | 20160811 | 20160811 | EXP | IT-CIPLA LTD.-2016IT17078 | CIPLA | 0.00 | Y | 0.00000 | 20160811 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126430231 | 12643023 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2, ON DAY 1, EVERY TWO WEEKS, 17 CYCLES | 77219 | 180 | MG/M**2 | ||||||||
| 126430231 | 12643023 | 2 | SS | Epirubicin | EPIRUBICIN | 1 | Unknown | UNK, SIX CYCLES | 0 | ||||||||||
| 126430231 | 12643023 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | UNK, 6 CYCLES | 0 | ||||||||||
| 126430231 | 12643023 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, 22 H CONTINUOUS INFUSION, ON DAYS 1 AND 2 EVERY TWO WEEKS, 17 CYCLES | 0 | 400 | MG/M**2 | ||||||||
| 126430231 | 12643023 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 600 MG/M2, 22-H CONTINUOUS INFUSIONON DAYS 1 AND 2 EVERY TWO WEEKS, 17 CYCLES | 0 | 600 | MG/M**2 | ||||||||
| 126430231 | 12643023 | 6 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, SIX CYCLES | 0 | ||||||||||
| 126430231 | 12643023 | 7 | SS | Cetuximab | CETUXIMAB | 1 | Intravenous (not otherwise specified) | 400 MG/M2, INITIAL DOSE | U | 0 | 400 | MG/M**2 | |||||||
| 126430231 | 12643023 | 8 | SS | Cetuximab | CETUXIMAB | 1 | Unknown | 250 MG/M2, WEEKLY DOSE, 17 CYCLES | U | 0 | 250 | MG/M**2 | |||||||
| 126430231 | 12643023 | 9 | SS | Cetuximab | CETUXIMAB | 1 | Unknown | 250 MG/M2, WEEKLY, 24 DOSES | U | 0 | 250 | MG/M**2 | |||||||
| 126430231 | 12643023 | 10 | SS | LFA | LEVOLEUCOVORIN | 1 | Intravenous (not otherwise specified) | 100 MG/M2, EVERY TWO WEEKS, 17 CYCLES | 0 | 100 | MG/M**2 | ||||||||
| 126430231 | 12643023 | 11 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | UNK, 6 CYCLES | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126430231 | 12643023 | 1 | Metastatic gastric cancer |
| 126430231 | 12643023 | 2 | Metastatic gastric cancer |
| 126430231 | 12643023 | 3 | Metastatic gastric cancer |
| 126430231 | 12643023 | 6 | Metastatic gastric cancer |
| 126430231 | 12643023 | 7 | Metastatic gastric cancer |
| 126430231 | 12643023 | 10 | Metastatic gastric cancer |
| 126430231 | 12643023 | 11 | Metastatic gastric cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126430231 | 12643023 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126430231 | 12643023 | Disease recurrence | |
| 126430231 | 12643023 | Hepatitis C | |
| 126430231 | 12643023 | Metastases to lymph nodes | |
| 126430231 | 12643023 | Rash |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |