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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127537331 | 12753733 | 1 | I | 20110118 | 20160905 | 20160916 | 20160916 | EXP | ES-BAXTER-2016BAX046407 | BAXTER | 66.63 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127537331 | 12753733 | 1 | PS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE | N | 12142 | 1470 | MG | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 127537331 | 12753733 | 2 | SS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | COMPLETE DOSE | N | 12142 | 1470 | MG | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 127537331 | 12753733 | 3 | SS | GENOXAL | CYCLOPHOSPHAMIDE | 1 | Unknown | DELAYED DUE TO NON-HEMATOLOGICAL TOXICITY | N | 12142 | 1470 | MG | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 127537331 | 12753733 | 4 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE | N | 0 | 540 | MG | |||||||
| 127537331 | 12753733 | 5 | SS | rituximab | RITUXIMAB | 1 | Unknown | COMPLETE DOSE | N | 0 | 980 | MG | |||||||
| 127537331 | 12753733 | 6 | SS | rituximab | RITUXIMAB | 1 | Unknown | DELAYED DUE TO NON-HEMATOLOGIC TOXICITY | N | 0 | 980 | MG | |||||||
| 127537331 | 12753733 | 7 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | COMPLETE DOSE | N | 0 | 147 | MG | |||||||
| 127537331 | 12753733 | 8 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | COMPLETE DOSE | N | 0 | 147 | MG | |||||||
| 127537331 | 12753733 | 9 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | DELAYED DUE TO NON-HEMATOLOGIC TOXICITY | N | 0 | 147 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127537331 | 12753733 | 1 | Chronic lymphocytic leukaemia |
| 127537331 | 12753733 | 4 | Chronic lymphocytic leukaemia |
| 127537331 | 12753733 | 7 | Chronic lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127537331 | 12753733 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127537331 | 12753733 | Constipation | |
| 127537331 | 12753733 | Nausea | |
| 127537331 | 12753733 | Platelet count decreased | |
| 127537331 | 12753733 | Respiratory disorder |
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 |
|---|---|---|---|---|---|---|
| 127537331 | 12753733 | 1 | 20031101 | 20111005 | 0 | |
| 127537331 | 12753733 | 2 | 20111102 | 20111104 | 0 | |
| 127537331 | 12753733 | 3 | 20111214 | 20111216 | 0 | |
| 127537331 | 12753733 | 4 | 20031101 | 20111005 | 0 | |
| 127537331 | 12753733 | 5 | 20111102 | 20111104 | 0 | |
| 127537331 | 12753733 | 6 | 20111214 | 20111216 | 0 | |
| 127537331 | 12753733 | 7 | 20031101 | 20111005 | 0 | |
| 127537331 | 12753733 | 8 | 20111102 | 20111104 | 0 | |
| 127537331 | 12753733 | 9 | 20111214 | 20111216 | 0 |