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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125251951 | 12525195 | 1 | I | 20160609 | 20160623 | 20160704 | 20160704 | EXP | US-BAXTER-2016BAX033860 | BAXTER | 33.00 | YR | F | Y | 0.00000 | 20160704 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125251951 | 12525195 | 1 | PS | CYCLOPHOSPHAMIDE FOR INJECTION, USP | CYCLOPHOSPHAMIDE | 1 | Unknown | HIGH DOSE | U | 40745 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 125251951 | 12525195 | 2 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | FLAG-IDA | U | 0 | |||||||||
| 125251951 | 12525195 | 3 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | CONDITIONING | U | 0 | |||||||||
| 125251951 | 12525195 | 4 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | U | 0 | |||||||||||
| 125251951 | 12525195 | 5 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | U | 0 | |||||||||||
| 125251951 | 12525195 | 6 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | FLAG-IDA | U | 0 | |||||||||
| 125251951 | 12525195 | 7 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | U | 0 | ||||||||||
| 125251951 | 12525195 | 8 | SS | CYTARABINE. | CYTARABINE | 1 | U | 0 | |||||||||||
| 125251951 | 12525195 | 9 | SS | granulocyte colony stimulating factor | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | FLAG-IDA | U | 0 | |||||||||
| 125251951 | 12525195 | 10 | SS | granulocyte colony stimulating factor | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | U | 0 | |||||||||||
| 125251951 | 12525195 | 11 | SS | granulocyte colony stimulating factor | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | U | 0 | |||||||||||
| 125251951 | 12525195 | 12 | SS | idarubicin | IDARUBICIN | 1 | Unknown | FLAG-IDA | U | 0 | |||||||||
| 125251951 | 12525195 | 13 | SS | idarubicin | IDARUBICIN | 1 | U | 0 | |||||||||||
| 125251951 | 12525195 | 14 | SS | idarubicin | IDARUBICIN | 1 | U | 0 | |||||||||||
| 125251951 | 12525195 | 15 | SS | blinatumomab | BLINATUMOMAB | 1 | Unknown | U | 0 | ||||||||||
| 125251951 | 12525195 | 16 | SS | blinatumomab | BLINATUMOMAB | 1 | U | 0 | |||||||||||
| 125251951 | 12525195 | 17 | SS | blinatumomab | BLINATUMOMAB | 1 | U | 0 | |||||||||||
| 125251951 | 12525195 | 18 | SS | asparaginase | ASPARAGINASE | 1 | Unknown | U | 0 | ||||||||||
| 125251951 | 12525195 | 19 | SS | asparaginase | ASPARAGINASE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125251951 | 12525195 | 1 | Bone marrow conditioning regimen |
| 125251951 | 12525195 | 2 | Salvage therapy |
| 125251951 | 12525195 | 3 | Bone marrow conditioning regimen |
| 125251951 | 12525195 | 4 | Philadelphia chromosome negative |
| 125251951 | 12525195 | 5 | B-cell type acute leukaemia |
| 125251951 | 12525195 | 6 | Salvage therapy |
| 125251951 | 12525195 | 7 | Philadelphia chromosome negative |
| 125251951 | 12525195 | 8 | B-cell type acute leukaemia |
| 125251951 | 12525195 | 9 | Salvage therapy |
| 125251951 | 12525195 | 10 | Philadelphia chromosome negative |
| 125251951 | 12525195 | 11 | B-cell type acute leukaemia |
| 125251951 | 12525195 | 12 | Salvage therapy |
| 125251951 | 12525195 | 13 | Philadelphia chromosome negative |
| 125251951 | 12525195 | 14 | B-cell type acute leukaemia |
| 125251951 | 12525195 | 15 | Salvage therapy |
| 125251951 | 12525195 | 16 | Philadelphia chromosome negative |
| 125251951 | 12525195 | 17 | B-cell type acute leukaemia |
| 125251951 | 12525195 | 18 | Philadelphia chromosome negative |
| 125251951 | 12525195 | 19 | B-cell type acute leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125251951 | 12525195 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125251951 | 12525195 | Acute lymphocytic leukaemia recurrent |
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 |
|---|---|---|---|---|---|---|
| 125251951 | 12525195 | 2 | 20150930 | 0 | ||
| 125251951 | 12525195 | 6 | 20150930 | 0 | ||
| 125251951 | 12525195 | 7 | 20151020 | 0 | ||
| 125251951 | 12525195 | 9 | 20150930 | 0 | ||
| 125251951 | 12525195 | 12 | 20150930 | 0 | ||
| 125251951 | 12525195 | 15 | 20151103 | 0 |