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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127719821 | 12771982 | 1 | I | 20160422 | 20160912 | 20160922 | 20160922 | EXP | US-BAXTER-2016BAX048067 | BAXTER | 8.77 | YR | F | Y | 0.00000 | 20160922 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127719821 | 12771982 | 1 | PS | CYCLOPHOSPHAMIDE FOR INJECTION, USP | CYCLOPHOSPHAMIDE | 1 | Unknown | DELAYED INTENSIFICATION OF CHEMOTHERAPY | D | 40745 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 127719821 | 12771982 | 2 | SS | CYCLOPHOSPHAMIDE FOR INJECTION, USP | CYCLOPHOSPHAMIDE | 1 | Unknown | DELAYED INTENSIFICATION OF CHEMOTHERAPY | D | 40745 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 127719821 | 12771982 | 3 | SS | CYCLOPHOSPHAMIDE FOR INJECTION, USP | CYCLOPHOSPHAMIDE | 1 | Unknown | 5 DAYS OF THERAPY RECEIVED; BLOCK 2 RELAPSE CHEMOTHERAPY | D | 40745 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 127719821 | 12771982 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 5 DAYS OF THERAPY RECEIVED; BLOCK 2 RELAPSE CHEMOTHERAPY | D | 0 | SOLUTION FOR INJECTION | ||||||||
| 127719821 | 12771982 | 5 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | D | 0 | |||||||||||
| 127719821 | 12771982 | 6 | SS | vincristine | VINCRISTINE | 1 | Unknown | INDUCTION PHASE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 7 | SS | vincristine | VINCRISTINE | 1 | Unknown | CONSOLIDATION PHASE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 8 | SS | vincristine | VINCRISTINE | 1 | Unknown | INTERIM MAINTENANCE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 9 | SS | vincristine | VINCRISTINE | 1 | Unknown | DELAYED INTENSIFICATION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 10 | SS | vincristine | VINCRISTINE | 1 | Unknown | MAINTENANCE DOSE OF CHEMOTHERAPY | D | 0 | /cycle | ||||||||
| 127719821 | 12771982 | 11 | SS | vincristine | VINCRISTINE | 1 | Intravenous (not otherwise specified) | BLOCK 1/REINDUCTION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 12 | SS | vincristine | VINCRISTINE | 1 | Intravenous (not otherwise specified) | BLOCK 2 RELAPSE CHEMOTHERAPY; DAY 1 | D | 0 | |||||||||
| 127719821 | 12771982 | 13 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | INDUCTION PHASE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 14 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | DELAYED INTENSIFICATION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 15 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | BLOCK 1/REINDUCTION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 16 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | BLOCK 2 RELAPSE CHEMOTHERAPY; DAY 1 | D | 0 | |||||||||
| 127719821 | 12771982 | 17 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | INDUCTION PHASE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 18 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | CONSOLIDATION PHASE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 19 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | HIGH DOSE METHOTREXATE; INTERIM MAINTENANCE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 20 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | INTERIM MAINTENANCE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 21 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | DELAYED INTENSIFICATION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 22 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | MAINTENANCE PHASE OF CHEMOTHERAPY | D | 0 | /cycle | ||||||||
| 127719821 | 12771982 | 23 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | MAINTENANCE PHASE OF CHEMOTHERAPY | D | 0 | /cycle | ||||||||
| 127719821 | 12771982 | 24 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | BLOCK 1/REINDUCTION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 25 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | BLOCK 2 RELAPSE CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 26 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | CONSOLIDATION PHASE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 27 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | DELAYED INTENSIFICATION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 28 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Unknown | CONSOLIDATION PHASE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 29 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Unknown | INTERIM MAINTENANCE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 30 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Unknown | MAINTENANCE DOSE OF CHEMOTHERAPY | D | 0 | /cycle | ||||||||
| 127719821 | 12771982 | 31 | SS | PEG/L-ASPARAGINASE | PEGASPARGASE | 1 | Unknown | INDUCTION PHASE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 32 | SS | PEG/L-ASPARAGINASE | PEGASPARGASE | 1 | Unknown | CONSOLIDATION PHASE OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 33 | SS | PEG/L-ASPARAGINASE | PEGASPARGASE | 1 | Unknown | DELAYED INTENSIFICATION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 34 | SS | PEG/L-ASPARAGINASE | PEGASPARGASE | 1 | Unknown | BLOCK 1/REINDUCTION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 35 | SS | doxorubicin | DOXORUBICIN | 1 | Unknown | DELAYED INTENSIFICATION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 36 | SS | thioguanine | THIOGUANINE | 1 | Unknown | DELAYED INTENSIFICATION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 37 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | MAINTENANCE DOSE OF CHEMOTHERAPY | D | 0 | /cycle | ||||||||
| 127719821 | 12771982 | 38 | SS | MITOXANTRONE | MITOXANTRONE HYDROCHLORIDE | 1 | Unknown | BLOCK 1/REINDUCTION OF CHEMOTHERAPY | D | 0 | |||||||||
| 127719821 | 12771982 | 39 | SS | MITOXANTRONE | MITOXANTRONE HYDROCHLORIDE | 1 | D | 0 | |||||||||||
| 127719821 | 12771982 | 40 | SS | daunorubicin | DAUNORUBICIN | 1 | Unknown | D | 0 | ||||||||||
| 127719821 | 12771982 | 41 | SS | Ara-C | CYTARABINE | 1 | Intrathecal | INDUCTION PHASE OF CHEMOTHERAPY | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127719821 | 12771982 | 1 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 2 | Acute lymphocytic leukaemia recurrent |
| 127719821 | 12771982 | 3 | Precursor B-lymphoblastic lymphoma refractory |
| 127719821 | 12771982 | 4 | Acute lymphocytic leukaemia recurrent |
| 127719821 | 12771982 | 5 | Precursor B-lymphoblastic lymphoma refractory |
| 127719821 | 12771982 | 6 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 7 | Acute lymphocytic leukaemia recurrent |
| 127719821 | 12771982 | 8 | Precursor B-lymphoblastic lymphoma refractory |
| 127719821 | 12771982 | 13 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 14 | Acute lymphocytic leukaemia recurrent |
| 127719821 | 12771982 | 15 | Precursor B-lymphoblastic lymphoma refractory |
| 127719821 | 12771982 | 17 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 18 | Acute lymphocytic leukaemia recurrent |
| 127719821 | 12771982 | 19 | Precursor B-lymphoblastic lymphoma refractory |
| 127719821 | 12771982 | 26 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 28 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 31 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 32 | Acute lymphocytic leukaemia recurrent |
| 127719821 | 12771982 | 33 | Precursor B-lymphoblastic lymphoma refractory |
| 127719821 | 12771982 | 35 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 36 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 37 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 38 | Acute lymphocytic leukaemia recurrent |
| 127719821 | 12771982 | 39 | Precursor B-lymphoblastic lymphoma refractory |
| 127719821 | 12771982 | 40 | B precursor type acute leukaemia |
| 127719821 | 12771982 | 41 | B precursor type acute leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127719821 | 12771982 | DE |
| 127719821 | 12771982 | OT |
| 127719821 | 12771982 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127719821 | 12771982 | Acute lymphocytic leukaemia recurrent | |
| 127719821 | 12771982 | Adenovirus infection | |
| 127719821 | 12771982 | Clostridium bacteraemia | |
| 127719821 | 12771982 | Colitis | |
| 127719821 | 12771982 | Death | |
| 127719821 | 12771982 | Infection reactivation | |
| 127719821 | 12771982 | Oral herpes | |
| 127719821 | 12771982 | Pericardial effusion | |
| 127719821 | 12771982 | Precursor B-lymphoblastic lymphoma refractory | |
| 127719821 | 12771982 | Streptococcal bacteraemia | |
| 127719821 | 12771982 | Therapy non-responder | |
| 127719821 | 12771982 | Thrombocytopenia | |
| 127719821 | 12771982 | Viraemia |
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 |
|---|---|---|---|---|---|---|
| 127719821 | 12771982 | 1 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 2 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 3 | 20160624 | 20160628 | 0 | |
| 127719821 | 12771982 | 4 | 20160624 | 20160628 | 0 | |
| 127719821 | 12771982 | 6 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 7 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 8 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 9 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 10 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 11 | 2016 | 0 | ||
| 127719821 | 12771982 | 12 | 2016 | 0 | ||
| 127719821 | 12771982 | 13 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 14 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 15 | 2016 | 0 | ||
| 127719821 | 12771982 | 16 | 2016 | 0 | ||
| 127719821 | 12771982 | 17 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 18 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 19 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 20 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 21 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 22 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 23 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 24 | 2016 | 0 | ||
| 127719821 | 12771982 | 25 | 2016 | 0 | ||
| 127719821 | 12771982 | 26 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 27 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 28 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 29 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 30 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 31 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 32 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 33 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 34 | 2016 | 0 | ||
| 127719821 | 12771982 | 35 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 36 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 37 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 38 | 2016 | 0 | ||
| 127719821 | 12771982 | 40 | 2015 | 2015 | 0 | |
| 127719821 | 12771982 | 41 | 2015 | 2015 | 0 |