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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127537141 | 12753714 | 1 | I | 20110214 | 20160905 | 20160916 | 20160916 | EXP | ES-BAXTER-2016BAX046404 | BAXTER | 73.75 | YR | Y | 0.00000 | 20160916 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127537141 | 12753714 | 1 | PS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 1 | Y | N | 12142 | 1275 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||
| 127537141 | 12753714 | 2 | SS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 2 | Y | N | 12142 | 1275 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||
| 127537141 | 12753714 | 3 | SS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 3 | Y | N | 12142 | 1275 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||
| 127537141 | 12753714 | 4 | SS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 4 | Y | N | 12142 | 1275 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||
| 127537141 | 12753714 | 5 | SS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 5 | Y | N | 12142 | 1275 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||
| 127537141 | 12753714 | 6 | SS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 6 | Y | N | 12142 | 1275 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||
| 127537141 | 12753714 | 7 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 1 | Y | N | 0 | 630 | MG | ||||||
| 127537141 | 12753714 | 8 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 2 | Y | N | 0 | 630 | MG | ||||||
| 127537141 | 12753714 | 9 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 3 | Y | N | 0 | 637 | MG | ||||||
| 127537141 | 12753714 | 10 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 4 | Y | N | 0 | 850 | MG | ||||||
| 127537141 | 12753714 | 11 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 5 | Y | N | 0 | 850 | MG | ||||||
| 127537141 | 12753714 | 12 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 6 | Y | N | 0 | 850 | MG | ||||||
| 127537141 | 12753714 | 13 | SS | vincristine | VINCRISTINE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 1 | Y | N | 0 | 2 | MG | ||||||
| 127537141 | 12753714 | 14 | SS | vincristine | VINCRISTINE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 2 | Y | N | 0 | 2 | MG | ||||||
| 127537141 | 12753714 | 15 | SS | vincristine | VINCRISTINE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 3 | Y | N | 0 | 2 | MG | ||||||
| 127537141 | 12753714 | 16 | SS | vincristine | VINCRISTINE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 4 | Y | N | 0 | 2 | MG | ||||||
| 127537141 | 12753714 | 17 | SS | vincristine | VINCRISTINE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 5 | Y | N | 0 | 2 | MG | ||||||
| 127537141 | 12753714 | 18 | SS | vincristine | VINCRISTINE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 6 | Y | N | 0 | 2 | MG | ||||||
| 127537141 | 12753714 | 19 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 1 | Y | N | 0 | 500 | MG | ||||||
| 127537141 | 12753714 | 20 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 2 | Y | N | 0 | 500 | MG | ||||||
| 127537141 | 12753714 | 21 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 3 | Y | N | 0 | 500 | MG | ||||||
| 127537141 | 12753714 | 22 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 4 | Y | N | 0 | 500 | MG | ||||||
| 127537141 | 12753714 | 23 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 5 | Y | N | 0 | 500 | MG | ||||||
| 127537141 | 12753714 | 24 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | COMPLETE DOSE, TREATMENT VISIT 6 | Y | N | 0 | 500 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127537141 | 12753714 | 1 | Chronic lymphocytic leukaemia |
| 127537141 | 12753714 | 7 | Chronic lymphocytic leukaemia |
| 127537141 | 12753714 | 13 | Chronic lymphocytic leukaemia |
| 127537141 | 12753714 | 19 | Chronic lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127537141 | 12753714 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127537141 | 12753714 | Blood bilirubin decreased | |
| 127537141 | 12753714 | Blood immunoglobulin G increased | |
| 127537141 | 12753714 | Blood lactate dehydrogenase increased | |
| 127537141 | 12753714 | Blood urea increased | |
| 127537141 | 12753714 | Hypoalbuminaemia | |
| 127537141 | 12753714 | Lymphocytosis | |
| 127537141 | 12753714 | Neutrophil count decreased |
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 |
|---|---|---|---|---|---|---|
| 127537141 | 12753714 | 1 | 20110214 | 20110218 | 0 | |
| 127537141 | 12753714 | 2 | 20110307 | 20110311 | 0 | |
| 127537141 | 12753714 | 3 | 20110328 | 20110401 | 0 | |
| 127537141 | 12753714 | 4 | 20110427 | 20110501 | 0 | |
| 127537141 | 12753714 | 5 | 20110528 | 20110601 | 0 | |
| 127537141 | 12753714 | 6 | 20110608 | 20110612 | 0 | |
| 127537141 | 12753714 | 7 | 20110214 | 20110218 | 0 | |
| 127537141 | 12753714 | 8 | 20110307 | 20110311 | 0 | |
| 127537141 | 12753714 | 9 | 20110328 | 20110401 | 0 | |
| 127537141 | 12753714 | 10 | 20110427 | 20110501 | 0 | |
| 127537141 | 12753714 | 11 | 20110528 | 20110601 | 0 | |
| 127537141 | 12753714 | 12 | 20110608 | 20110612 | 0 | |
| 127537141 | 12753714 | 13 | 20110214 | 20110218 | 0 | |
| 127537141 | 12753714 | 14 | 20110307 | 20110311 | 0 | |
| 127537141 | 12753714 | 15 | 20110328 | 20110401 | 0 | |
| 127537141 | 12753714 | 16 | 20110427 | 20110501 | 0 | |
| 127537141 | 12753714 | 17 | 20110528 | 20110601 | 0 | |
| 127537141 | 12753714 | 18 | 20110608 | 20110612 | 0 | |
| 127537141 | 12753714 | 19 | 20110214 | 20110218 | 0 | |
| 127537141 | 12753714 | 20 | 20110307 | 20110311 | 0 | |
| 127537141 | 12753714 | 21 | 20110328 | 20110401 | 0 | |
| 127537141 | 12753714 | 22 | 20110427 | 20110501 | 0 | |
| 127537141 | 12753714 | 23 | 20110528 | 20110601 | 0 | |
| 127537141 | 12753714 | 24 | 20110608 | 20110612 | 0 |