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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122458043 | 12245804 | 3 | F | 20160916 | 20160407 | 20160921 | EXP | NO-AMGEN-NORSP2016041840 | AMGEN | 65.00 | YR | E | F | Y | 0.00000 | 20160921 | OT | NO | NO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122458043 | 12245804 | 1 | PS | NEUPOGEN | FILGRASTIM | 1 | Unknown | 10 MUG/KG, QD (10 MCG, QD) | D | 103353 | 10 | UG/KG | UNKNOWN FORMULATION | QD | |||||
| 122458043 | 12245804 | 2 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Oral | 35 MG/M2, UNK | 0 | 35 | MG/M**2 | ||||||||
| 122458043 | 12245804 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Intrathecal | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 122458043 | 12245804 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 40 MG/M2, UNK (40 MG/M2 ON DAYS 1-29, TAPERING TO DAY 35) | 0 | 40 | MG/M**2 | ||||||||
| 122458043 | 12245804 | 5 | SS | SENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 750 MG/M2 ON DAYS 15, 22 AND 29 | 0 | 750 | MG/M**2 | ||||||||
| 122458043 | 12245804 | 6 | SS | DAUNORUBICIN | DAUNORUBICIN | 1 | Intravenous (not otherwise specified) | 50 MG/M2, UNK | 0 | 50 | MG/M**2 | ||||||||
| 122458043 | 12245804 | 7 | SS | ASPARAGINASE | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | 10 IU ON DAYS 8-21 | 0 | 10 | IU | ||||||||
| 122458043 | 12245804 | 8 | SS | ASPARAGINASE | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | ON DAYS 8-21 | 0 | 10000 | IU | ||||||||
| 122458043 | 12245804 | 9 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | 30 MG/M2 ON DAYS 8, 15 AND 22 | 0 | 30 | MG/M**2 | INJECTION | |||||||
| 122458043 | 12245804 | 10 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 200 MG/M2, UNK | 0 | 200 | MG/M**2 | ||||||||
| 122458043 | 12245804 | 11 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | 40 MG, UNK | 0 | 40 | MG | ||||||||
| 122458043 | 12245804 | 12 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intratracheal | 15 MG, UNK (15 MG ON DAYS 15, 29) | 0 | 15 | MG | INJECTION | |||||||
| 122458043 | 12245804 | 13 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 1500 MG/M2, UNK | 0 | 1500 | MG/M**2 | INJECTION | |||||||
| 122458043 | 12245804 | 14 | SS | THIOGUANINE | THIOGUANINE | 1 | Intravenous (not otherwise specified) | 150 MG/M2, UNK | 0 | 150 | MG/M**2 | ||||||||
| 122458043 | 12245804 | 15 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 1.5 MG/M2 (1.5 MG/M2 ON DAYS 1, 8, 15, 22 AND 29) | 0 | 1.5 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122458043 | 12245804 | 1 | Peripheral blood stem cell apheresis |
| 122458043 | 12245804 | 2 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 122458043 | 12245804 | 3 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 122458043 | 12245804 | 5 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 122458043 | 12245804 | 6 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 122458043 | 12245804 | 7 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 122458043 | 12245804 | 9 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 122458043 | 12245804 | 10 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 122458043 | 12245804 | 12 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 122458043 | 12245804 | 14 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 122458043 | 12245804 | 15 | Precursor T-lymphoblastic lymphoma/leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122458043 | 12245804 | OT |
| 122458043 | 12245804 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122458043 | 12245804 | Death | |
| 122458043 | 12245804 | Febrile neutropenia | |
| 122458043 | 12245804 | Haematotoxicity | |
| 122458043 | 12245804 | Intracranial venous sinus thrombosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |