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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126804632 | 12680463 | 2 | F | 20160114 | 20160902 | 20160824 | 20160913 | EXP | GR-PFIZER INC-2016399078 | PFIZER | 6.00 | YR | M | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126804632 | 12680463 | 1 | PS | Aracytin | CYTARABINE | 1 | UNK | U | 71868 | POWDER FOR SOLUTION FOR INJECTION | |||||||||
| 126804632 | 12680463 | 2 | SS | IDARUBICIN HCL | IDARUBICIN HYDROCHLORIDE | 1 | UNK | U | 50661 | ||||||||||
| 126804632 | 12680463 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 1000 MG/M2, (1GR/M2) UNK | U | 11719 | 1000 | MG/M**2 | ||||||||
| 126804632 | 12680463 | 4 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 3.10 MG/M2, DAY +1 AND +3 | U | 11719 | 3.1 | MG/M**2 | ||||||||
| 126804632 | 12680463 | 5 | SS | CLOFARABINE | CLOFARABINE | 1 | UNK | U | 0 | ||||||||||
| 126804632 | 12680463 | 6 | SS | ETOPOSIDE (VP16) | ETOPOSIDE | 1 | UNK | U | 0 | ||||||||||
| 126804632 | 12680463 | 7 | SS | ENDOXAN /00021101/ | CYCLOPHOSPHAMIDE | 1 | UNK | U | 0 | ||||||||||
| 126804632 | 12680463 | 8 | SS | ERWINASE /00143501/ | ASPARAGINASE | 1 | UNK | Y | 0 | ||||||||||
| 126804632 | 12680463 | 9 | SS | ONCOVIN | VINCRISTINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 126804632 | 12680463 | 10 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | UNK | U | 0 | ||||||||||
| 126804632 | 12680463 | 11 | SS | FLUDARABIN | FLUDARABINE PHOSPHATE | 1 | UNK | U | 0 | ||||||||||
| 126804632 | 12680463 | 12 | SS | BUSILVEX | BUSULFAN | 1 | 1.1 MG/KG, X 16 DOSES | U | 0 | 1.1 | MG/KG | ||||||||
| 126804632 | 12680463 | 13 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | 30 MG/KG, X 1 X 5 DAYS | U | 0 | 30 | MG/KG | ||||||||
| 126804632 | 12680463 | 14 | SS | THIOTEPA. | THIOTEPA | 1 | 5 MG/KG, X 2 X 1 DAY | U | 0 | 5 | MG/KG | ||||||||
| 126804632 | 12680463 | 15 | SS | ATG /00575401/ | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | 7.5 MG/KG, TOTAL DOSE | U | 0 | 7.5 | MG/KG | ||||||||
| 126804632 | 12680463 | 16 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | 4 MG/KG, FROM DAY-1 | U | 0 | 4 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126804632 | 12680463 | 1 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 2 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 3 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 5 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 6 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 7 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 9 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 10 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 11 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 12 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 13 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 14 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 15 | Acute lymphocytic leukaemia |
| 126804632 | 12680463 | 16 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126804632 | 12680463 | HO |
| 126804632 | 12680463 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126804632 | 12680463 | Acute lymphocytic leukaemia | |
| 126804632 | 12680463 | Disease recurrence | |
| 126804632 | 12680463 | Epstein-Barr virus infection | |
| 126804632 | 12680463 | Febrile neutropenia | |
| 126804632 | 12680463 | Hypersensitivity |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |