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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127609001 | 12760900 | 1 | I | 20160908 | 20160919 | 20160919 | EXP | FR-BAXTER-2016BAX048589 | BAXTER | TAMBURINI J, LEVY V, CHALETEIX C, FERMAND J, DELMER A, STALNIEWICZ L, MOREL P, DREYFUS F, GRANGE M, CHRISTIAN B, CHOQUET S, LEBLOND V. FLUDARABINE PLUS CYCLOPHOSPHAMIDE IN WALDENSTROM^S MACROGLOBULINEMIA: RESULTS IN 49 PATIENTS. LEUKEMIA. 2005 JAN 01;19 (10):1831-1834. | 0.00 | A | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127609001 | 12760900 | 1 | PS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 12142 | POWDER FOR SOLUTION FOR INJECTION | |||||||||
| 127609001 | 12760900 | 2 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 127609001 | 12760900 | 3 | SS | trimethoprim-sulfamethoxazole | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 200-40 MG/DAY | U | 0 | |||||||||
| 127609001 | 12760900 | 4 | SS | pentamidine | PENTAMIDINE | 1 | Unknown | U | 0 | 300 | MG | /month | |||||||
| 127609001 | 12760900 | 5 | SS | valaciclovir | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127609001 | 12760900 | 1 | Waldenstrom's macroglobulinaemia |
| 127609001 | 12760900 | 2 | Waldenstrom's macroglobulinaemia |
| 127609001 | 12760900 | 3 | Antifungal prophylaxis |
| 127609001 | 12760900 | 4 | Antifungal prophylaxis |
| 127609001 | 12760900 | 5 | Antiviral prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127609001 | 12760900 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127609001 | 12760900 | Therapy non-responder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |