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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127112121 | 12711212 | 1 | I | 20160114 | 20160824 | 20160902 | 20160902 | EXP | GR-BAXTER-2016BAX045418 | BAXTER | 5.41 | YR | M | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127112121 | 12711212 | 1 | PS | ENDOXAN 1000 MG - POWDER FOR SOLUTION FOR INJECTION | CYCLOPHOSPHAMIDE | 1 | Unknown | REGIMEN #1 (ALL R3 PROTOCOL) | U | 12142 | POWDER FOR SOLUTION FOR INJECTION | /cycle | |||||||
| 127112121 | 12711212 | 2 | SS | Aracytin | CYTARABINE | 1 | Unknown | REGIMEN #1 (HIGH DOSE) | U | 0 | POWDER FOR SOLUTION FOR INJECTION | /cycle | |||||||
| 127112121 | 12711212 | 3 | SS | Aracytin | CYTARABINE | 1 | Unknown | REGIMEN #1 (R3) | U | 0 | POWDER FOR SOLUTION FOR INJECTION | /cycle | |||||||
| 127112121 | 12711212 | 4 | SS | idarubicin HCl | IDARUBICIN HYDROCHLORIDE | 1 | Unknown | REGIMEN #1 | U | 0 | /cycle | ||||||||
| 127112121 | 12711212 | 5 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | REGIMEN #1 (HIGH DOSE) | U | 0 | 1000 | MG/M**2 | /cycle | ||||||
| 127112121 | 12711212 | 6 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | REGIMEN #2 (DAY +1 AND +3) | U | 0 | 3.1 | MG/M**2 | |||||||
| 127112121 | 12711212 | 7 | SS | clofarabine | CLOFARABINE | 1 | Unknown | REGIMEN #1 (ALL R3 PROTOCOL) | U | 0 | /cycle | ||||||||
| 127112121 | 12711212 | 8 | SS | VP-16 | ETOPOSIDE | 1 | Unknown | REGIMEN #1 (ALL R3 PROTOCOL) | U | 0 | /cycle | ||||||||
| 127112121 | 12711212 | 9 | SS | Erwinase | ASPARAGINASE ERWINIA CHRYSANTHEMI | 1 | Unknown | REGIMEN #1 (HIGH DOSE) | U | 0 | /cycle | ||||||||
| 127112121 | 12711212 | 10 | SS | ONCOVIN | VINCRISTINE SULFATE | 1 | Unknown | REGIMEN #1 (HIGH DOSE) | U | 0 | /cycle | ||||||||
| 127112121 | 12711212 | 11 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | REGIMEN #1 (HIGH DOSE) | U | 0 | /cycle | ||||||||
| 127112121 | 12711212 | 12 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | REGIMEN #1 | U | 0 | /cycle | ||||||||
| 127112121 | 12711212 | 13 | SS | Busilvex | BUSULFAN | 1 | Unknown | REGIMEN #1 (16 DOSES) | U | 0 | 1.1 | MG/KG | /cycle | ||||||
| 127112121 | 12711212 | 14 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | REGIMEN #1, 30 MG/KG X 1 X 5 DAYS | U | 0 | 30 | MG/KG | /cycle | ||||||
| 127112121 | 12711212 | 15 | SS | THIOTEPA. | THIOTEPA | 1 | Unknown | REGIMEN #1, 5 MG/KG X 2 X 1 DAY | U | 0 | 5 | MG/KG | /cycle | ||||||
| 127112121 | 12711212 | 16 | SS | antithymocyte immunoglobulin | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Unknown | REGIMEN #1, 7.5 MG/KG TOTAL DOSE | U | 0 | 7.5 | MG/KG | /cycle | ||||||
| 127112121 | 12711212 | 17 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | REGIMEN #1 (FROM DAY 1) | U | 0 | 4 | MG/KG | /cycle | ||||||
| 127112121 | 12711212 | 18 | C | 6-mercaptopurine | MERCAPTOPURINE | 1 | Oral | 0 | QD | ||||||||||
| 127112121 | 12711212 | 19 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 5 GM/M2 | 0 | ||||||||||
| 127112121 | 12711212 | 20 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | /wk | ||||||||||
| 127112121 | 12711212 | 21 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | |||||||||||
| 127112121 | 12711212 | 22 | C | asparaginase Medac | ASPARAGINASE | 1 | Unknown | 0 | |||||||||||
| 127112121 | 12711212 | 23 | C | ONCASPAR | PEGASPARGASE | 1 | Unknown | 0 | |||||||||||
| 127112121 | 12711212 | 24 | C | TARGOCID | TEICOPLANIN | 1 | Unknown | 0 | |||||||||||
| 127112121 | 12711212 | 25 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | INDUCTION CHEMOTHERAPY PER ALLIC 2009 BFM PROTOCOL | 0 | ||||||||||
| 127112121 | 12711212 | 26 | C | vincristine | VINCRISTINE | 1 | Unknown | INDUCTION CHEMOTHERAPY PER ALLIC 2009 BFM PROTOCOL | 0 | ||||||||||
| 127112121 | 12711212 | 27 | C | doxorubicin | DOXORUBICIN | 1 | Unknown | INDUCTION CHEMOTHERAPY PER ALLIC 2009 BFM PROTOCOL | 0 | ||||||||||
| 127112121 | 12711212 | 28 | C | asparaginase | ASPARAGINASE | 1 | Unknown | INDUCTION CHEMOTHERAPY PER ALLIC 2009 BFM PROTOCOL | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127112121 | 12711212 | 1 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 2 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 4 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 5 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 7 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 8 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 9 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 10 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 11 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 12 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 13 | Bone marrow conditioning regimen |
| 127112121 | 12711212 | 14 | Bone marrow conditioning regimen |
| 127112121 | 12711212 | 15 | Bone marrow conditioning regimen |
| 127112121 | 12711212 | 16 | Bone marrow conditioning regimen |
| 127112121 | 12711212 | 17 | Prophylaxis against graft versus host disease |
| 127112121 | 12711212 | 18 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 19 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 21 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 22 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 23 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 24 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 25 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 26 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 27 | Acute lymphocytic leukaemia |
| 127112121 | 12711212 | 28 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127112121 | 12711212 | HO |
| 127112121 | 12711212 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127112121 | 12711212 | Acute lymphocytic leukaemia recurrent | |
| 127112121 | 12711212 | Drug hypersensitivity | |
| 127112121 | 12711212 | Epstein-Barr virus infection | |
| 127112121 | 12711212 | Febrile neutropenia |
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 |
|---|---|---|---|---|---|---|
| 127112121 | 12711212 | 9 | 20160114 | 0 | ||
| 127112121 | 12711212 | 18 | 20150310 | 0 | ||
| 127112121 | 12711212 | 20 | 20150310 | 0 | ||
| 127112121 | 12711212 | 26 | 20140612 | 0 | ||
| 127112121 | 12711212 | 27 | 20140612 | 0 | ||
| 127112121 | 12711212 | 28 | 20140612 | 0 |