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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126677051 | 12667705 | 1 | I | 200004 | 20160809 | 20160819 | 20160819 | EXP | FR-IMPAX LABORATORIES, INC-2016-IPXL-00892 | 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 | 80.00 | YR | Y | 0.00000 | 20160819 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126677051 | 12667705 | 1 | PS | LEUCOVORIN CALCIUM. | LEUCOVORIN CALCIUM | 1 | Intravenous bolus | 200 MG/M^2, OVER 120 MIN FOR DAY 1 | U | 74544 | 200 | MG/M**2 | TABLET | ||||||
| 126677051 | 12667705 | 2 | C | 5 FU | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M^2, OVER 90 MIN | 0 | 400 | MG/M**2 | ||||||||
| 126677051 | 12667705 | 3 | C | 5 FU | FLUOROURACIL | 1 | Intravenous bolus | 2400 MG/M^2, OVER 2 DAYS | 0 | 2400 | MG/M**2 | ||||||||
| 126677051 | 12667705 | 4 | C | IRINOTECAN | IRINOTECAN | 1 | Intravenous bolus | 180 MG/M^2, OVER 90 MIN | 0 | 180 | MG/M**2 | ||||||||
| 126677051 | 12667705 | 5 | C | ONDANSETRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 126677051 | 12667705 | 6 | C | ATROPINE. | ATROPINE | 1 | Unknown | UNK | 0 | ||||||||||
| 126677051 | 12667705 | 7 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 126677051 | 12667705 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126677051 | 12667705 | 1 | Colon cancer stage III |
| 126677051 | 12667705 | 2 | Colon cancer stage III |
| 126677051 | 12667705 | 4 | Colon cancer stage III |
| 126677051 | 12667705 | 5 | Antiemetic supportive care |
| 126677051 | 12667705 | 6 | Anticholinergic syndrome |
| 126677051 | 12667705 | 7 | Antiemetic supportive care |
| 126677051 | 12667705 | 8 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126677051 | 12667705 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126677051 | 12667705 | Anaphylactic shock | |
| 126677051 | 12667705 | Rash |
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 |
|---|---|---|---|---|---|---|
| 126677051 | 12667705 | 1 | 200004 | 0 | ||
| 126677051 | 12667705 | 2 | 200004 | 0 | ||
| 126677051 | 12667705 | 3 | 200004 | 0 | ||
| 126677051 | 12667705 | 4 | 200004 | 0 | ||
| 126677051 | 12667705 | 5 | 200004 | 0 | ||
| 126677051 | 12667705 | 6 | 200004 | 0 | ||
| 126677051 | 12667705 | 7 | 200004 | 0 | ||
| 126677051 | 12667705 | 8 | 200004 | 0 |