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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120764142 | 12076414 | 2 | F | 20160909 | 20160215 | 20160915 | EXP | NO-NOMAADVRE-NOMAADVRE-2016-22076 | NO-ASPEN PHARMA TRADING LIMITED US-AG-2016-000604 | ASPEN | HOLTE H. MULTIMODAL TREATMENT WITH ALL-LIKE CHEMOTHERAPY, AUTO-SCT AND RADIOTHERAPY FOR LYMPHOBLASTIC LYMPHOMA. ACTA ONCOLOGICA. 2014;53(5):680-687. | 65.00 | YR | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120764142 | 12076414 | 1 | PS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Oral | ON DAYS 64-111 | 0 | 35 | MG/M**2 | ||||||||
| 120764142 | 12076414 | 2 | SS | TIOGUANINE | THIOGUANINE ANHYDROUS | 1 | Intravenous (not otherwise specified) | ON DAYS 43-47 | 0 | 150 | MG/M**2 | ||||||||
| 120764142 | 12076414 | 3 | SS | ASPARAGINASE | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | ON DAYS 8,15,21 | 0 | 10 | IU | ||||||||
| 120764142 | 12076414 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Intrathecal | 0 | 10 | MG | |||||||||
| 120764142 | 12076414 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | ON DAYS 1-29, TAPERING TO DAY 35 | 0 | 40 | MG/M**2 | ||||||||
| 120764142 | 12076414 | 6 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | ON DAYS 43-47 | 0 | 200 | MG/M**2 | ||||||||
| 120764142 | 12076414 | 7 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | ON DAYS 78,92,106 | 0 | 40 | MG | ||||||||
| 120764142 | 12076414 | 8 | SS | G-CSF | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | 0 | 10 | UG/KG | QD | ||||||||
| 120764142 | 12076414 | 9 | SS | Sendoxan | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | ON DAYS 15, 22 AND 29 | 0 | 750 | MG/M**2 | ||||||||
| 120764142 | 12076414 | 10 | SS | DAUNORUBICIN | DAUNORUBICIN | 1 | Intravenous (not otherwise specified) | ON DAYS 43,45,47 | 0 | 50 | MG/M**2 | ||||||||
| 120764142 | 12076414 | 11 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | ON DAYS 15,29,43,64 | 0 | 15 | MG | SOLUTION FOR INJECTION | |||||||
| 120764142 | 12076414 | 12 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | ON DAYS 64,78 | 0 | 1500 | MG/M**2 | SOLUTION FOR INJECTION | |||||||
| 120764142 | 12076414 | 13 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | ON DAYS 1,8, 15 ,22 AND 29 | 0 | 1.5 | MG/M**2 | ||||||||
| 120764142 | 12076414 | 14 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | ON DAYS 8, 15 AND 22 | 0 | 30 | MG/M**2 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120764142 | 12076414 | 1 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 2 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 3 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 4 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 5 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 6 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 8 | Peripheral blood stem cell apheresis |
| 120764142 | 12076414 | 9 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 10 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 11 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 13 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120764142 | 12076414 | 14 | Precursor T-lymphoblastic lymphoma/leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120764142 | 12076414 | DE |
| 120764142 | 12076414 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120764142 | 12076414 | Death | |
| 120764142 | 12076414 | Febrile neutropenia | |
| 120764142 | 12076414 | Haematotoxicity | |
| 120764142 | 12076414 | 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 |