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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127886881 | 12788688 | 1 | I | 20160628 | 20160919 | 20160928 | 20160928 | EXP | FR-BAXTER-2016BAX048438 | BAXTER | 41.74 | YR | M | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127886881 | 12788688 | 1 | PS | UROMITEXAN 1 G/10 ML, SOLUTION INJECTABLE POUR PERFUSION EN FLACON | MESNA | 1 | Unknown | U | 19884 | SOLUTION FOR INJECTION | |||||||||
| 127886881 | 12788688 | 2 | SS | UROMITEXAN 1 G/10 ML, SOLUTION INJECTABLE POUR PERFUSION EN FLACON | MESNA | 1 | Unknown | U | 19884 | SOLUTION FOR INJECTION | |||||||||
| 127886881 | 12788688 | 3 | SS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 12142 | 1200 | MG | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 127886881 | 12788688 | 4 | SS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 12142 | 1200 | MG | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 127886881 | 12788688 | 5 | SS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | THIRD INFUSION OF ENDOXAN | 12142 | 1200 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||||
| 127886881 | 12788688 | 6 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Unknown | U | 0 | SOLUTION FOR INFUSION | |||||||||
| 127886881 | 12788688 | 7 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous bolus | 500 MG IV BOLUS THEN 1 MG/KG DAILY | D | 0 | QD | ||||||||
| 127886881 | 12788688 | 8 | SS | CALCIPARINE | HEPARIN CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 127886881 | 12788688 | 9 | SS | KARDEGIC | ASPIRIN LYSINE | 1 | Unknown | U | 0 | ||||||||||
| 127886881 | 12788688 | 10 | SS | DAFALGAN | ACETAMINOPHEN | 1 | Unknown | U | 0 | ||||||||||
| 127886881 | 12788688 | 11 | SS | CEFOTAXIME | CEFOTAXIME SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 127886881 | 12788688 | 12 | SS | perindopril | PERINDOPRIL | 1 | Unknown | U | 0 | ||||||||||
| 127886881 | 12788688 | 13 | SS | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | U | 0 | ||||||||||
| 127886881 | 12788688 | 14 | SS | pantoprazole | PANTOPRAZOLE SODIUM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127886881 | 12788688 | 1 | Product used for unknown indication |
| 127886881 | 12788688 | 3 | Polyarteritis nodosa |
| 127886881 | 12788688 | 6 | Product used for unknown indication |
| 127886881 | 12788688 | 7 | Polyarteritis nodosa |
| 127886881 | 12788688 | 8 | Product used for unknown indication |
| 127886881 | 12788688 | 9 | Product used for unknown indication |
| 127886881 | 12788688 | 10 | Product used for unknown indication |
| 127886881 | 12788688 | 11 | Product used for unknown indication |
| 127886881 | 12788688 | 12 | Product used for unknown indication |
| 127886881 | 12788688 | 13 | Product used for unknown indication |
| 127886881 | 12788688 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127886881 | 12788688 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127886881 | 12788688 | Hepatic steatosis | |
| 127886881 | 12788688 | Hepatocellular injury | |
| 127886881 | 12788688 | Jaundice cholestatic |
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 |
|---|---|---|---|---|---|---|
| 127886881 | 12788688 | 1 | 20160611 | 20160611 | 0 | |
| 127886881 | 12788688 | 2 | 20160624 | 20160624 | 0 | |
| 127886881 | 12788688 | 3 | 20160611 | 20160611 | 0 | |
| 127886881 | 12788688 | 4 | 20160624 | 20160624 | 0 | |
| 127886881 | 12788688 | 5 | 20160708 | 20160708 | 0 | |
| 127886881 | 12788688 | 6 | 20160610 | 0 | ||
| 127886881 | 12788688 | 7 | 20160609 | 20160612 | 0 | |
| 127886881 | 12788688 | 8 | 20160610 | 0 | ||
| 127886881 | 12788688 | 9 | 20160610 | 0 | ||
| 127886881 | 12788688 | 10 | 20160610 | 0 | ||
| 127886881 | 12788688 | 11 | 20160610 | 0 | ||
| 127886881 | 12788688 | 12 | 20160624 | 0 | ||
| 127886881 | 12788688 | 13 | 20160624 | 0 | ||
| 127886881 | 12788688 | 14 | 20160607 | 0 |