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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351791 | 12535179 | 1 | I | 20160317 | 20160627 | 20160707 | 20160707 | EXP | CA-BAXTER-2016BAX035276 | BAXTER | 52.00 | YR | M | Y | 0.00000 | 20160707 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351791 | 12535179 | 1 | PS | PROCYTOX (CYCLOPHOSPHAMIDE) 2000MG/VIAL | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 12142 | POWDER FOR SOLUTION FOR INJECTION | |||||||||
| 125351791 | 12535179 | 2 | SS | L-asparaginase | ASPARAGINASE | 1 | Unknown | INTENSIFICATION PROTOCOL | U | 0 | |||||||||
| 125351791 | 12535179 | 3 | SS | vincristine | VINCRISTINE | 1 | Unknown | INTENSIFICATION PROTOCOL | U | 0 | |||||||||
| 125351791 | 12535179 | 4 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | 0 | |||||||||||
| 125351791 | 12535179 | 5 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | FLAG-IDA REGIMEN | 0 | ||||||||||
| 125351791 | 12535179 | 6 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | FLAG-IDA REGIMEN | 0 | ||||||||||
| 125351791 | 12535179 | 7 | SS | granulocyte colony-stimulating factor | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | FLAG-IDA REGIMEN | 0 | ||||||||||
| 125351791 | 12535179 | 8 | SS | idarubicin | IDARUBICIN | 1 | Unknown | FLAG-IDA REGIMEN | 0 | ||||||||||
| 125351791 | 12535179 | 9 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | /wk | ||||||||||
| 125351791 | 12535179 | 10 | C | 6-MP | MERCAPTOPURINE | 1 | Unknown | 0 | |||||||||||
| 125351791 | 12535179 | 11 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125351791 | 12535179 | 1 | Bone marrow conditioning regimen |
| 125351791 | 12535179 | 2 | Product used for unknown indication |
| 125351791 | 12535179 | 3 | Product used for unknown indication |
| 125351791 | 12535179 | 4 | Prophylaxis against graft versus host disease |
| 125351791 | 12535179 | 5 | Product used for unknown indication |
| 125351791 | 12535179 | 6 | Product used for unknown indication |
| 125351791 | 12535179 | 7 | Product used for unknown indication |
| 125351791 | 12535179 | 8 | Product used for unknown indication |
| 125351791 | 12535179 | 9 | Product used for unknown indication |
| 125351791 | 12535179 | 10 | Product used for unknown indication |
| 125351791 | 12535179 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125351791 | 12535179 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125351791 | 12535179 | Acute lymphocytic leukaemia recurrent | |
| 125351791 | 12535179 | Bone marrow failure | |
| 125351791 | 12535179 | Febrile neutropenia | |
| 125351791 | 12535179 | Influenza like illness | |
| 125351791 | 12535179 | Mental status changes | |
| 125351791 | 12535179 | Metapneumovirus infection | |
| 125351791 | 12535179 | Pneumonia viral | |
| 125351791 | 12535179 | Pyrexia | |
| 125351791 | 12535179 | Staphylococcal sepsis |
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 |
|---|---|---|---|---|---|---|
| 125351791 | 12535179 | 2 | 20141025 | 0 | ||
| 125351791 | 12535179 | 3 | 20141025 | 0 | ||
| 125351791 | 12535179 | 4 | 201505 | 0 | ||
| 125351791 | 12535179 | 5 | 20160322 | 0 | ||
| 125351791 | 12535179 | 6 | 20160322 | 0 | ||
| 125351791 | 12535179 | 7 | 20160322 | 0 | ||
| 125351791 | 12535179 | 8 | 20160322 | 0 |