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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125729081 | 12572908 | 1 | I | 20160518 | 20160705 | 20160720 | 20160720 | EXP | PV20160225 | FR-ACCORD-042528 | ACCORD | 78.00 | YR | M | Y | 56.00000 | KG | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125729081 | 12572908 | 1 | PS | Fluorouracil Accord | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | RECEIVED SECOND COURSE 3000 MG/M^2 FOR 48 HOURS I.E. 4500 MG OF FLUOROURACIL. | Y | 40743 | 3000 | MG/M**2 | |||||||
| 125729081 | 12572908 | 2 | SS | CALCIUM FOLINATE | LEUCOVORIN CALCIUM | 1 | SECOND COURSE ON 600 MG?RECEIVED FIRST COURSE ON 29-APR-2016 | U | 0 | 400 | MG/M**2 | ||||||||
| 125729081 | 12572908 | 3 | I | ARAVA | LEFLUNOMIDE | 1 | Oral | DOSE DECREASE TO 10 MG | Y | 0 | 20 | MG | |||||||
| 125729081 | 12572908 | 4 | I | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Oral | Y | 0 | 500 | MG | TID | |||||||
| 125729081 | 12572908 | 5 | I | CEFOTAXIME | CEFOTAXIME SODIUM | 1 | Intravenous (not otherwise specified) | Y | 0 | 1 | G | TID | |||||||
| 125729081 | 12572908 | 6 | C | Lasilix | FUROSEMIDE | 1 | 0 | 40 | MG | ||||||||||
| 125729081 | 12572908 | 7 | C | Cortancyl | PREDNISONE | 1 | 0 | 5 | MG | ||||||||||
| 125729081 | 12572908 | 8 | C | Zamudol | TRAMADOL HYDROCHLORIDE | 1 | STRENGTH: 100 | 0 | BID | ||||||||||
| 125729081 | 12572908 | 9 | C | Calcidose | CALCIUM CARBONATE | 1 | 1 SACHET EVERY DAY | 0 | 500 | MG | QD | ||||||||
| 125729081 | 12572908 | 10 | C | ARANESP | DARBEPOETIN ALFA | 1 | 0 | 150 | UG | INJECTION | /wk | ||||||||
| 125729081 | 12572908 | 11 | C | Fumafer | FERROUS FUMARATE | 1 | 1 TABLET TWICE A DAY | 0 | TABLET | BID | |||||||||
| 125729081 | 12572908 | 12 | C | Inexium | ESOMEPRAZOLE | 1 | 0 | 40 | MG | ||||||||||
| 125729081 | 12572908 | 13 | C | Stilnox | ZOLPIDEM TARTRATE | 1 | 0 | TABLET | QD | ||||||||||
| 125729081 | 12572908 | 14 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | 5 | MG | ||||||||||
| 125729081 | 12572908 | 15 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | 0 | 20 | MG | ||||||||||
| 125729081 | 12572908 | 16 | C | Bisoce | BISOPROLOL | 1 | 0 | 1.25 | MG | ||||||||||
| 125729081 | 12572908 | 17 | C | Triatec | RAMIPRIL | 1 | 0 | 2.5 | MG | ||||||||||
| 125729081 | 12572908 | 18 | C | INNOHEP | TINZAPARIN SODIUM | 1 | Subcutaneous | DOSE EQUILIBRATED TO THE INTERNATIONAL NORMALIZED RATIO | 0 | ||||||||||
| 125729081 | 12572908 | 19 | C | Tazocilline | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | 0 | ||||||||||||
| 125729081 | 12572908 | 20 | C | PHYTOMENADIONE | PHYTONADIONE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 125729081 | 12572908 | 21 | C | CALCIPARINE | HEPARIN CALCIUM | 1 | Subcutaneous | 0 | .2 | ML | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125729081 | 12572908 | 1 | Colorectal adenocarcinoma |
| 125729081 | 12572908 | 2 | Colorectal adenocarcinoma |
| 125729081 | 12572908 | 3 | Colorectal adenocarcinoma |
| 125729081 | 12572908 | 4 | Colorectal adenocarcinoma |
| 125729081 | 12572908 | 5 | Colorectal adenocarcinoma |
| 125729081 | 12572908 | 16 | Cardiac failure |
| 125729081 | 12572908 | 17 | Cardiac failure |
| 125729081 | 12572908 | 19 | Gastroenteritis |
| 125729081 | 12572908 | 21 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125729081 | 12572908 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125729081 | 12572908 | Chills | |
| 125729081 | 12572908 | Condition aggravated | |
| 125729081 | 12572908 | Diarrhoea | |
| 125729081 | 12572908 | Drug eruption | |
| 125729081 | 12572908 | Drug interaction | |
| 125729081 | 12572908 | Eosinophilia | |
| 125729081 | 12572908 | Hyperthermia | |
| 125729081 | 12572908 | Nausea | |
| 125729081 | 12572908 | Pruritus | |
| 125729081 | 12572908 | Renal impairment | |
| 125729081 | 12572908 | Toxic skin eruption | |
| 125729081 | 12572908 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125729081 | 12572908 | 1 | 20160512 | 20160513 | 0 | |
| 125729081 | 12572908 | 2 | 20160512 | 0 | ||
| 125729081 | 12572908 | 3 | 2002 | 20160525 | 0 | |
| 125729081 | 12572908 | 4 | 20160523 | 20160527 | 0 | |
| 125729081 | 12572908 | 5 | 20160523 | 20160530 | 0 |