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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125282861 | 12528286 | 1 | I | 20160121 | 20160622 | 20160705 | 20160705 | EXP | FR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-051828 | BRISTOL MYERS SQUIBB | 78.46 | YR | M | Y | 56.00000 | KG | 20160705 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125282861 | 12528286 | 1 | PS | COUMADINE | WARFARIN SODIUM | 1 | Unknown | 2 MG, UNK | Y | 9218 | 2 | MG | TABLET | QD | |||||
| 125282861 | 12528286 | 2 | C | XARELTO | RIVAROXABAN | 1 | Unknown | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 125282861 | 12528286 | 3 | C | KARDEGIC | ASPIRIN LYSINE | 1 | Unknown | 75 MG, QD | U | 0 | 75 | MG | QD | ||||||
| 125282861 | 12528286 | 4 | C | ARAVA | LEFLUNOMIDE | 1 | Unknown | 20 MG, QD | Y | 0 | 20 | MG | QD | ||||||
| 125282861 | 12528286 | 5 | C | ARAVA | LEFLUNOMIDE | 1 | Unknown | 10 MG, QD | Y | 0 | 10 | MG | QD | ||||||
| 125282861 | 12528286 | 6 | C | CORTANCYL | PREDNISONE | 1 | Unknown | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 125282861 | 12528286 | 7 | C | ZAMUDOL | TRAMADOL HYDROCHLORIDE | 1 | Unknown | 1 DF, BID | U | 0 | 1 | DF | BID | ||||||
| 125282861 | 12528286 | 8 | C | CALCIDOSE /00944201/ | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Unknown | 500 MG, QD | U | 0 | 500 | MG | QD | ||||||
| 125282861 | 12528286 | 9 | C | ARANESP | DARBEPOETIN ALFA | 1 | Unknown | 150 ?G, QWK | U | 0 | 150 | UG | /wk | ||||||
| 125282861 | 12528286 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 125282861 | 12528286 | 11 | C | FUMAFER | FERROUS FUMARATE | 1 | Unknown | 1 TAB, BID | U | 0 | 1 | DF | BID | ||||||
| 125282861 | 12528286 | 12 | C | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | 40 MG, QD | U | 0 | 40 | MG | QD | ||||||
| 125282861 | 12528286 | 13 | C | STILNOX | ZOLPIDEM TARTRATE | 1 | Unknown | 1 TAB, QD | U | 0 | 1 | DF | QD | ||||||
| 125282861 | 12528286 | 14 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | 20 MG, QD | U | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125282861 | 12528286 | 1 | Product used for unknown indication |
| 125282861 | 12528286 | 2 | Product used for unknown indication |
| 125282861 | 12528286 | 3 | Product used for unknown indication |
| 125282861 | 12528286 | 4 | Product used for unknown indication |
| 125282861 | 12528286 | 6 | Product used for unknown indication |
| 125282861 | 12528286 | 7 | Product used for unknown indication |
| 125282861 | 12528286 | 8 | Product used for unknown indication |
| 125282861 | 12528286 | 9 | Product used for unknown indication |
| 125282861 | 12528286 | 10 | Product used for unknown indication |
| 125282861 | 12528286 | 11 | Product used for unknown indication |
| 125282861 | 12528286 | 12 | Product used for unknown indication |
| 125282861 | 12528286 | 13 | Product used for unknown indication |
| 125282861 | 12528286 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125282861 | 12528286 | OT |
| 125282861 | 12528286 | HO |
| 125282861 | 12528286 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125282861 | 12528286 | Acute kidney injury | |
| 125282861 | 12528286 | Adenocarcinoma of colon | |
| 125282861 | 12528286 | Gastroenteritis | |
| 125282861 | 12528286 | Hypercreatininaemia | |
| 125282861 | 12528286 | International normalised ratio increased | |
| 125282861 | 12528286 | Lactic acidosis | |
| 125282861 | 12528286 | Overdose | |
| 125282861 | 12528286 | Rectal haemorrhage | |
| 125282861 | 12528286 | Shock haemorrhagic |
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 |
|---|---|---|---|---|---|---|
| 125282861 | 12528286 | 1 | 201601 | 20160121 | 0 | |
| 125282861 | 12528286 | 4 | 200201 | 0 |