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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122856362 | 12285636 | 2 | F | 20160403 | 20160902 | 20160420 | 20160914 | EXP | IT-MINISAL02-354864 | IT-TEVA-652878ACC | TEVA | 64.08 | YR | F | Y | 0.00000 | 20160914 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122856362 | 12285636 | 1 | PS | LEVOFOLINIC ACID | LEVOLEUCOVORIN | 1 | Intravenous (not otherwise specified) | 638.5 MG CYCLICAL | N | U | 71198 | 638.5 | MG | POWDER FOR INJECTION | |||||
| 122856362 | 12285636 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 638.5 MG CYCLICAL | N | U | 40333 | 638.5 | MG | SOLUTION FOR INFUSION | |||||
| 122856362 | 12285636 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | 3831 MG CYCLICAL | N | U | 40333 | 3831 | MG | SOLUTION FOR INFUSION | |||||
| 122856362 | 12285636 | 4 | SS | AFLIBERCEPT | AFLIBERCEPT | 1 | Intravenous (not otherwise specified) | 264 MG CYCLICAL | N | U | 4F003B | 0 | 264 | MG | SOLUTION FOR INFUSION | ||||
| 122856362 | 12285636 | 5 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 287.3 MG CYCLICAL | N | U | 0 | 287.3 | MG | SOLUTION FOR INFUSION | |||||
| 122856362 | 12285636 | 6 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 8 MG | U | 0 | 8 | MG | SOLUTION FOR INJECTION | ||||||
| 122856362 | 12285636 | 7 | C | ATROPINE. | ATROPINE | 1 | Intravenous (not otherwise specified) | .2 MG | U | 0 | .2 | MG | SOLUTION FOR INJECTION | ||||||
| 122856362 | 12285636 | 8 | C | PALONOSETRON | PALONOSETRON | 1 | Intravenous (not otherwise specified) | 250 UG | U | 0 | 250 | UG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122856362 | 12285636 | 1 | Colon neoplasm |
| 122856362 | 12285636 | 2 | Colon neoplasm |
| 122856362 | 12285636 | 4 | Colon neoplasm |
| 122856362 | 12285636 | 5 | Colon neoplasm |
| 122856362 | 12285636 | 6 | Product used for unknown indication |
| 122856362 | 12285636 | 7 | Product used for unknown indication |
| 122856362 | 12285636 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122856362 | 12285636 | DE |
| 122856362 | 12285636 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122856362 | 12285636 | Anaemia | |
| 122856362 | 12285636 | Febrile neutropenia | |
| 122856362 | 12285636 | Leukopenia | |
| 122856362 | 12285636 | Platelet count decreased | |
| 122856362 | 12285636 | Thrombocytopenia | |
| 122856362 | 12285636 | White blood cell count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 122856362 | 12285636 | 1 | 20160323 | 20160323 | 0 | |
| 122856362 | 12285636 | 2 | 20160323 | 20160323 | 0 | |
| 122856362 | 12285636 | 3 | 20160323 | 20160325 | 0 | |
| 122856362 | 12285636 | 4 | 20160323 | 20160323 | 0 | |
| 122856362 | 12285636 | 5 | 20160323 | 20160323 | 0 | |
| 122856362 | 12285636 | 6 | 20160323 | 20160323 | 0 | |
| 122856362 | 12285636 | 7 | 20160323 | 20160323 | 0 | |
| 122856362 | 12285636 | 8 | 20160323 | 20160323 | 0 |