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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127432421 | 12743242 | 1 | I | 2011 | 20160905 | 20160914 | 20160914 | EXP | ES-BAXTER-2016BAX046402 | BAXTER | 81.20 | YR | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127432421 | 12743242 | 1 | PS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE | 12142 | 750 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||||
| 127432421 | 12743242 | 2 | SS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE | 12142 | 750 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||||
| 127432421 | 12743242 | 3 | SS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE | 12142 | 750 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||||
| 127432421 | 12743242 | 4 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE | 0 | 500 | MG | ||||||||
| 127432421 | 12743242 | 5 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE | 0 | 100 | MG | ||||||||
| 127432421 | 12743242 | 6 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE | 0 | 830 | MG | ||||||||
| 127432421 | 12743242 | 7 | SS | rituximab | RITUXIMAB | 1 | Unknown | DELAY DUE TO FEBRILE NEUTROPENIA, SINGLE DOSE | 0 | 860 | MG | ||||||||
| 127432421 | 12743242 | 8 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DATE | 0 | 850 | MG | ||||||||
| 127432421 | 12743242 | 9 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | COMPLETE DOSE | 0 | 99 | MG | ||||||||
| 127432421 | 12743242 | 10 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | COMPLETE DOSE | 0 | 99 | MG | ||||||||
| 127432421 | 12743242 | 11 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | DELAY AND REDUCE DUE TO HEMATOLOGIC/NON HEMATOLOGIC TOXICITY | 0 | 90 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127432421 | 12743242 | 1 | Chronic lymphocytic leukaemia |
| 127432421 | 12743242 | 4 | Chronic lymphocytic leukaemia |
| 127432421 | 12743242 | 9 | Chronic lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127432421 | 12743242 | DE |
| 127432421 | 12743242 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127432421 | 12743242 | Disease progression | |
| 127432421 | 12743242 | Enteritis | |
| 127432421 | 12743242 | Febrile neutropenia |
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 |
|---|---|---|---|---|---|---|
| 127432421 | 12743242 | 1 | 20110531 | 20110603 | 0 | |
| 127432421 | 12743242 | 2 | 20110628 | 20110630 | 0 | |
| 127432421 | 12743242 | 3 | 20110912 | 20110914 | 0 | |
| 127432421 | 12743242 | 4 | 20110531 | 20110603 | 0 | |
| 127432421 | 12743242 | 5 | 20110531 | 0 | ||
| 127432421 | 12743242 | 6 | 20110628 | 20110630 | 0 | |
| 127432421 | 12743242 | 7 | 20110808 | 20110808 | 0 | |
| 127432421 | 12743242 | 8 | 20110912 | 20110914 | 0 | |
| 127432421 | 12743242 | 9 | 20110531 | 20110603 | 0 | |
| 127432421 | 12743242 | 10 | 20110628 | 20110630 | 0 | |
| 127432421 | 12743242 | 11 | 20110912 | 20110914 | 0 |