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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126730321 | 12673032 | 1 | I | 20160809 | 20160822 | 20160822 | EXP | GR-IMPAX LABORATORIES, INC-2016-IPXL-00894 | IMPAX | FLORIT-SUREDA M, CONDE-ESTEVEZ D, VIDAL J, MONTAGUT C.. HYPERSENSITIVITY REACTION CAUSED BY FOLINIC ACID ADMINISTRATION: A CASE REPORT AND LITERATURE REVIEW. JOURNAL OF CHEMOTHERAPY. 2016;1-6 | 67.00 | YR | F | Y | 0.00000 | 20160822 | MD | US | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126730321 | 12673032 | 1 | PS | LEUCOVORIN CALCIUM. | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | UNK | Y | 74544 | TABLET | ||||||||
| 126730321 | 12673032 | 2 | C | 5 FLUORO URACIL | FLUOROURACIL | 1 | Unknown | UNK | 0 | ||||||||||
| 126730321 | 12673032 | 3 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | (18 CYCLES) | 0 | ||||||||||
| 126730321 | 12673032 | 4 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | (BOLUS) | 0 | ||||||||||
| 126730321 | 12673032 | 5 | C | CETUXIMAB | CETUXIMAB | 1 | Unknown | (18 CYCLES) | 0 | ||||||||||
| 126730321 | 12673032 | 6 | C | CETUXIMAB | CETUXIMAB | 1 | Unknown | (25 MG 62.5 ML INFUSED) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126730321 | 12673032 | 1 | Colon cancer stage IV |
| 126730321 | 12673032 | 2 | Colon cancer stage IV |
| 126730321 | 12673032 | 3 | Colon cancer stage IV |
| 126730321 | 12673032 | 5 | Colon cancer stage IV |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126730321 | 12673032 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126730321 | 12673032 | Anaphylactic reaction | |
| 126730321 | 12673032 | Anaphylactic shock |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |