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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125542291 | 12554229 | 1 | I | 20160518 | 20160705 | 20160713 | 20160713 | EXP | FR-SA-2016SA124894 | AVENTIS | 78.00 | YR | E | M | Y | 56.00000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125542291 | 12554229 | 1 | SS | CALCIUM FOLINATE | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | Y | UNK | 0 | 600 | MG | |||||||
| 125542291 | 12554229 | 2 | SS | CALCIUM FOLINATE | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | Y | UNK | 0 | 600 | MG | |||||||
| 125542291 | 12554229 | 3 | PS | ARAVA | LEFLUNOMIDE | 1 | Oral | Y | UNK | 20905 | 20 | MG | FILM-COATED TABLET | QD | |||||
| 125542291 | 12554229 | 4 | SS | ARAVA | LEFLUNOMIDE | 1 | Oral | Y | UNK | 20905 | 10 | MG | FILM-COATED TABLET | QD | |||||
| 125542291 | 12554229 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 4500 MG OVER 48 HOURS FROM 12-13 / 05/16 | Y | UNK | 0 | 3600 | MG | ||||||
| 125542291 | 12554229 | 6 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 4500 MG OVER 48 HOURS FROM 12-13 / 05/16 | Y | UNK | 0 | 4500 | MG | ||||||
| 125542291 | 12554229 | 7 | C | PREVISCAN | FLUINDIONE | 1 | 0 | ||||||||||||
| 125542291 | 12554229 | 8 | C | XARELTO | RIVAROXABAN | 1 | 0 | 10 | MG | QD | |||||||||
| 125542291 | 12554229 | 9 | C | KARDEGIC | ASPIRIN LYSINE | 1 | 0 | 75 | MG | QD | |||||||||
| 125542291 | 12554229 | 10 | C | LASILIX | FUROSEMIDE | 1 | 0 | 40 | MG | QD | |||||||||
| 125542291 | 12554229 | 11 | C | CORTANCYL | PREDNISONE | 1 | 0 | 5 | MG | QD | |||||||||
| 125542291 | 12554229 | 12 | C | ZAMUDOL | TRAMADOL HYDROCHLORIDE | 1 | 100 LP 2 TIMES A DAY | 0 | BID | ||||||||||
| 125542291 | 12554229 | 13 | C | CALCIDOSE | CALCIUM CARBONATE | 1 | 1 SACHET PER DAY | 0 | 500 | MG | QD | ||||||||
| 125542291 | 12554229 | 14 | C | ARANESP | DARBEPOETIN ALFA | 1 | 0 | 150 | UG | /wk | |||||||||
| 125542291 | 12554229 | 15 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | 5 | MG | QD | |||||||||
| 125542291 | 12554229 | 16 | C | FUMAFER | FERROUS FUMARATE | 1 | 0 | 1 | DF | TABLET | BID | ||||||||
| 125542291 | 12554229 | 17 | C | INEXIUM | ESOMEPRAZOLE | 1 | 0 | 40 | MG | QD | |||||||||
| 125542291 | 12554229 | 18 | C | STILNOX | ZOLPIDEM TARTRATE | 1 | 0 | 1 | DF | TABLET | QD | ||||||||
| 125542291 | 12554229 | 19 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | 0 | 20 | MG | QD | |||||||||
| 125542291 | 12554229 | 20 | C | BISOCE | BISOPROLOL | 1 | 0 | 1.25 | MG | QD | |||||||||
| 125542291 | 12554229 | 21 | C | TRIATEC | RAMIPRIL | 1 | 0 | 2.5 | MG | QD | |||||||||
| 125542291 | 12554229 | 22 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 | 2 | MG | QD | |||||||||
| 125542291 | 12554229 | 23 | C | INNOHEP | TINZAPARIN SODIUM | 1 | Subcutaneous | 0 | |||||||||||
| 125542291 | 12554229 | 24 | C | CLAFORAN | CEFOTAXIME SODIUM | 1 | 0 | ||||||||||||
| 125542291 | 12554229 | 25 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | TID | ||||||||
| 125542291 | 12554229 | 26 | C | TAZOCILLINE | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | 0 | ||||||||||||
| 125542291 | 12554229 | 27 | C | VITAMIN K | PHYTONADIONE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 125542291 | 12554229 | 28 | C | CALCIPARINE | HEPARIN CALCIUM | 1 | Subcutaneous | 0 | .2 | ML | Q12H | ||||||||
| 125542291 | 12554229 | 29 | C | CEFOTAXIME | CEFOTAXIME SODIUM | 1 | Intravenous (not otherwise specified) | 0 | 1 | G | TID | ||||||||
| 125542291 | 12554229 | 30 | C | CEFOTAXIME | CEFOTAXIME SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125542291 | 12554229 | 20 | Cardiac failure |
| 125542291 | 12554229 | 21 | Cardiac failure |
| 125542291 | 12554229 | 24 | Gastroenteritis |
| 125542291 | 12554229 | 25 | Gastroenteritis |
| 125542291 | 12554229 | 26 | Gastroenteritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125542291 | 12554229 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125542291 | 12554229 | Chills | |
| 125542291 | 12554229 | Diarrhoea | |
| 125542291 | 12554229 | Nausea | |
| 125542291 | 12554229 | 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 |
|---|---|---|---|---|---|---|
| 125542291 | 12554229 | 1 | 20160429 | 20160430 | 0 | |
| 125542291 | 12554229 | 2 | 20160512 | 20160513 | 0 | |
| 125542291 | 12554229 | 3 | 200201 | 0 | ||
| 125542291 | 12554229 | 4 | 20160525 | 0 | ||
| 125542291 | 12554229 | 5 | 20160429 | 20160430 | 0 | |
| 125542291 | 12554229 | 6 | 20160512 | 20160513 | 0 | |
| 125542291 | 12554229 | 8 | 201508 | 0 | ||
| 125542291 | 12554229 | 25 | 20160527 | 0 | ||
| 125542291 | 12554229 | 30 | 20160529 | 20160530 | 0 |