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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127967531 | 12796753 | 1 | I | 20160919 | 20160929 | 20160929 | EXP | FR-FRESENIUS KABI-FK201607203 | FRESENIUS KABI | SOUCHET L,LEVY V,OUZEGDOUH M,TAMBURINI J,DELMER A,DUPUIS J. EFFICACY AND LONG-TERM TOXICITY OF THE RITUXIMAB-FLUDARABINE-CYCLOPHOSPHAMIDE COMBINATION THERAPY IN WALDENSTROM^S MACROGLOBULINEMIA. AM-J-HEMATOL 2016;91(8):782-786. | 0.00 | A | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127967531 | 12796753 | 1 | PS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Oral | U | 78393 | 40 | MG/M**2 | UNKNOWN | |||||||
| 127967531 | 12796753 | 2 | SS | CYCLOPHOSPHAMIDE (Manufacturer unknown) | CYCLOPHOSPHAMIDE | 1 | Oral | U | 0 | 250 | MG/M**2 | UNKNOWN | |||||||
| 127967531 | 12796753 | 3 | SS | RITUXIMAB | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 375 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127967531 | 12796753 | 1 | Waldenstrom's macroglobulinaemia |
| 127967531 | 12796753 | 2 | Waldenstrom's macroglobulinaemia |
| 127967531 | 12796753 | 3 | Waldenstrom's macroglobulinaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127967531 | 12796753 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127967531 | 12796753 | Cystitis haemorrhagic | |
| 127967531 | 12796753 | Disseminated tuberculosis | |
| 127967531 | 12796753 | Escherichia infection | |
| 127967531 | 12796753 | Infection reactivation | |
| 127967531 | 12796753 | Meningitis histoplasma | |
| 127967531 | 12796753 | Pyelonephritis | |
| 127967531 | 12796753 | Sepsis | |
| 127967531 | 12796753 | Septic shock |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |