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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125512263 | 12551226 | 3 | F | 20150511 | 20160720 | 20160713 | 20160729 | EXP | US-CIPLA LTD.-2016US09478 | CIPLA | THOMAS SA, TOMEH N, THEARD S.. FLUOROURACIL-INDUCED HYPERAMMONEMIA IN A PATIENT WITH COLORECTAL CANCER. ANTICANCER RESEARCH. 2015;35 (12):6761 TO 6763 | 0.00 | Y | 0.00000 | 20160729 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125512263 | 12551226 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2, OVER 90 MIN ON DAY 1 | U | U | 77219 | 180 | MG/M**2 | ||||||
| 125512263 | 12551226 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 2400 MG/M2, CONTINUOUS INFUSION OVER 46 H BEGINNING ON DAY 1; CYCLE REPEATED EVERY 14 DAYS | Y | U | 0 | 2400 | MG/M**2 | INFUSION | |||||
| 125512263 | 12551226 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 400 MG/M2, ON DAY 1; CYCLE REPEATED EVERY 14 DAYS | Y | U | 0 | 400 | MG/M**2 | INFUSION | |||||
| 125512263 | 12551226 | 4 | SS | AVASTIN | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 7.5 MG/KG, EVERY 3 WEEKS | U | U | 0 | 7.5 | MG/KG | ||||||
| 125512263 | 12551226 | 5 | SS | Folinic acid | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 400 MG/M2, OVER 2 H ON DAY 1 | U | U | 0 | 400 | MG/M**2 | ||||||
| 125512263 | 12551226 | 6 | SS | ATIVAN | LORAZEPAM | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125512263 | 12551226 | 1 | Colorectal cancer |
| 125512263 | 12551226 | 2 | Colorectal cancer |
| 125512263 | 12551226 | 4 | Colorectal cancer |
| 125512263 | 12551226 | 5 | Colorectal cancer |
| 125512263 | 12551226 | 6 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125512263 | 12551226 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125512263 | 12551226 | Alanine aminotransferase increased | |
| 125512263 | 12551226 | Azotaemia | |
| 125512263 | 12551226 | Blood alkaline phosphatase increased | |
| 125512263 | 12551226 | Blood uric acid increased | |
| 125512263 | 12551226 | Diarrhoea | |
| 125512263 | 12551226 | Hyperammonaemic encephalopathy | |
| 125512263 | 12551226 | Hypernatraemia | |
| 125512263 | 12551226 | Metabolic acidosis | |
| 125512263 | 12551226 | Nausea | |
| 125512263 | 12551226 | Retching | |
| 125512263 | 12551226 | Somnolence | |
| 125512263 | 12551226 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |