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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125165762 | 12516576 | 2 | F | 20160714 | 20160630 | 20160718 | EXP | US-TEVA-671442USA | TEVA | MW S. BENEFIT OF URIDINE TRIACETATE (VISTOGARD) IN RESCUING SEVERE 5-FLUOROURACIL TOXICITY IN PATIENTS WITH DIHYDROPYRIMIDINE DEHYDROGENASE (DPYD) DEFICIENCY.. CANCER CHEMOTHERAPY AND PHARMACOLOGY. 2016 JUN 08;. | 75.00 | YR | M | Y | 0.00000 | 20160718 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125165762 | 12516576 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 2550MG OVER 30 MINUTES ONCE WEEKLY ON WEEKS 1-3 FOLLOWED BY A REST PERIOD OF 1 WEEK | U | 40333 | |||||||||
| 125165762 | 12516576 | 2 | C | VISTOGARD | URIDINE TRIACETATE | 1 | Oral | AT EVERY 8 HOURS FOR 8 DOSES | U | 0 | |||||||||
| 125165762 | 12516576 | 3 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 125165762 | 12516576 | 4 | C | warfarin | WARFARIN | 1 | Unknown | U | 0 | ||||||||||
| 125165762 | 12516576 | 5 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | U | 0 | ||||||||||
| 125165762 | 12516576 | 6 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125165762 | 12516576 | 1 | Pancreatic carcinoma metastatic |
| 125165762 | 12516576 | 2 | Pancreatic carcinoma metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125165762 | 12516576 | HO |
| 125165762 | 12516576 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125165762 | 12516576 | Anaemia | |
| 125165762 | 12516576 | Asthenia | |
| 125165762 | 12516576 | Blood creatinine increased | |
| 125165762 | 12516576 | Decreased appetite | |
| 125165762 | 12516576 | Disseminated intravascular coagulation | |
| 125165762 | 12516576 | Mental status changes | |
| 125165762 | 12516576 | Nausea | |
| 125165762 | 12516576 | Pancytopenia | |
| 125165762 | 12516576 | Thrombocytopenia | |
| 125165762 | 12516576 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |