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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127216531 | 12721653 | 1 | I | 20141023 | 20160824 | 20160907 | 20160907 | EXP | GR-SA-2016SA156456 | AVENTIS | 6.00 | YR | C | M | Y | 0.00000 | 20160907 | MD | GR | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127216531 | 12721653 | 1 | PS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | U | UNKNOWN | 20038 | 30 | MG/KG | |||||||
| 127216531 | 12721653 | 2 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Unknown | U | UNKNOWN | 20038 | |||||||||
| 127216531 | 12721653 | 3 | SS | EVOLTRA | CLOFARABINE | 1 | Unknown | U | UNKNOWN | 21673 | |||||||||
| 127216531 | 12721653 | 4 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Unknown | U | UNKNOWN | 0 | 7.5 | MG | |||||||
| 127216531 | 12721653 | 5 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | U | UNKNOWN | 0 | 4 | MG/KG | |||||||
| 127216531 | 12721653 | 6 | SS | ARACYTIN | CYTARABINE | 1 | Unknown | POWDER FOR SOLUTION FOR INJECTION | U | UNKNOWN | 0 | ||||||||
| 127216531 | 12721653 | 7 | SS | IDARUBICIN | IDARUBICIN | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 127216531 | 12721653 | 8 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | U | UNKNOWN | 0 | 1000 | MG/M**2 | |||||||
| 127216531 | 12721653 | 9 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | U | UNKNOWN | 0 | 3.1 | MG/M**2 | QOD | ||||||
| 127216531 | 12721653 | 10 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 127216531 | 12721653 | 11 | SS | ERWINASE | ASPARAGINASE ERWINIA CHRYSANTHEMI | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 127216531 | 12721653 | 12 | SS | ONCOVIN | VINCRISTINE SULFATE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 127216531 | 12721653 | 13 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 127216531 | 12721653 | 14 | SS | BUSILVEX | BUSULFAN | 1 | Unknown | U | UNKNOWN | 0 | 1.1 | MG/KG | |||||||
| 127216531 | 12721653 | 15 | SS | THIOTEPA. | THIOTEPA | 1 | Unknown | U | UNKNOWN | 0 | 5 | MG/KG | |||||||
| 127216531 | 12721653 | 16 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Unknown | U | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127216531 | 12721653 | 1 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 2 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 3 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 4 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 5 | Prophylaxis against graft versus host disease |
| 127216531 | 12721653 | 6 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 7 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 8 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 9 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 10 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 12 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 13 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 14 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 15 | Acute lymphocytic leukaemia |
| 127216531 | 12721653 | 16 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127216531 | 12721653 | HO |
| 127216531 | 12721653 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127216531 | 12721653 | Acute lymphocytic leukaemia | |
| 127216531 | 12721653 | Disease recurrence | |
| 127216531 | 12721653 | Epstein-Barr virus infection | |
| 127216531 | 12721653 | Febrile neutropenia | |
| 127216531 | 12721653 | Hypersensitivity |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |