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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118767672 | 11876767 | 2 | F | 20160708 | 20151229 | 20160712 | EXP | US-MYLANLABS-2015M1047197 | MYLAN | THOMAS SA, TOMEH N, THEARD S. FLUOROURACIL-INDUCED HYPERAMMONEMIA IN A PATIENT WITH COLORECTAL CANCER. ANTICANCER-RES 2015;35(12):6761-6763. | 0.00 | Y | 0.00000 | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118767672 | 11876767 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2 ON DAY 1 FOLLOWED BY 2400 MG/M2 CONTINUOUS INFUSION OVER 46 H | Y | U | 202668 | INJECTION | |||||||
| 118767672 | 11876767 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | 2400 MG/M2 CONTINUOUS INFUSION OVER 46 H | Y | U | 202668 | INJECTION | |||||||
| 118767672 | 11876767 | 3 | C | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2 OVER 90 MIN ON DAY 1 | 0 | ||||||||||
| 118767672 | 11876767 | 4 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 400 MG/M2 OVER 2 H ON DAY 1 | 0 | ||||||||||
| 118767672 | 11876767 | 5 | C | AVASTIN | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 7.5MG/KG EVERY 3 WEEKS | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118767672 | 11876767 | 1 | Colon cancer |
| 118767672 | 11876767 | 3 | Colon cancer |
| 118767672 | 11876767 | 4 | Colon cancer |
| 118767672 | 11876767 | 5 | Colon cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118767672 | 11876767 | HO |
| 118767672 | 11876767 | OT |
| 118767672 | 11876767 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118767672 | 11876767 | Hyperammonaemic encephalopathy | |
| 118767672 | 11876767 | Nausea | |
| 118767672 | 11876767 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |