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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120787004 | 12078700 | 4 | F | 20160909 | 20160216 | 20160922 | EXP | NO-MYLANLABS-2016M1004137 | NO-ACCORD-037922 | ACCORD | BERSVENDSEN H, KOLSTAD A, BLYSTAD AK, AURLIEN E, FOSSA A, KVALOY SO, ET AL. MULTIMODAL TREATMENT WITH ALL-LIKE CHEMOTHERAPY, AUTO-SCT AND RADIOTHERAPY FOR LYMPHOBLASTIC LYMPHOMA. ACTA-ONCOL 2014;53(5):680-687. | 65.00 | YR | F | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120787004 | 12078700 | 1 | PS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 15 MG INTRATHECAL ON DAYS 15 AND 29 | D | 40716 | 1500 | MG | SOLUTION FOR INJECTION | ||||||
| 120787004 | 12078700 | 2 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | 30 MG/M2 ON DAYS 8, 15 AND 22 | D | 200750109 | 30 | MG/M**2 | INJECTION | ||||||
| 120787004 | 12078700 | 3 | SS | ASPARAGINASE | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | 10 IU ON DAYS 8-21 | D | 0 | 10000 | IU | |||||||
| 120787004 | 12078700 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 1.5 MG/M2 ON DAYS 1, 8, 15, 22 AND 29 | D | 0 | 1.5 | MG/M**2 | |||||||
| 120787004 | 12078700 | 5 | SS | CYCLOPHOSPHAMIDE/CYCLOPHOSPHAMIDE MONOHYDRATE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 750 MG/M2 ON DAYS 15, 22 AND 29 | D | 0 | 750 | MG/M**2 | |||||||
| 120787004 | 12078700 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 40 MG/M2 ON DAYS 1-29, TAPERING TO DAY 35?ALSO RECEIVED 10 MG INTRATHECAL (INDICATION UNKNOWN). | D | 0 | 40 | MG/M**2 | |||||||
| 120787004 | 12078700 | 7 | SS | DAUNORUBICIN | DAUNORUBICIN | 1 | Intravenous (not otherwise specified) | D | 0 | 50 | MG/M**2 | ||||||||
| 120787004 | 12078700 | 8 | SS | CYTARABINE/CYTARABINE HYDROCHLORIDE/CYTARABINE OCFOSFATE | CYTARABINE | 1 | Intravenous (not otherwise specified) | ALSO RECEIVED 40 MG, INTRATHECAL | D | 0 | 200 | MG | |||||||
| 120787004 | 12078700 | 9 | SS | TIOGUANINE | THIOGUANINE ANHYDROUS | 1 | Intravenous (not otherwise specified) | D | 0 | 150 | MG/M**2 | ||||||||
| 120787004 | 12078700 | 10 | SS | GRANULOCYTE COLONY STIMULATING | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | D | 0 | 10 | UG/KG | |||||||||
| 120787004 | 12078700 | 11 | SS | MERCAPTOPURINE/MERCAPTOPURINE ANHYDROUS | MERCAPTOPURINE | 1 | Oral | D | 0 | 35 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120787004 | 12078700 | 1 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120787004 | 12078700 | 2 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120787004 | 12078700 | 3 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120787004 | 12078700 | 4 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120787004 | 12078700 | 5 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120787004 | 12078700 | 6 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120787004 | 12078700 | 7 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120787004 | 12078700 | 8 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120787004 | 12078700 | 9 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120787004 | 12078700 | 10 | Peripheral blood stem cell apheresis |
| 120787004 | 12078700 | 11 | Precursor T-lymphoblastic lymphoma/leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120787004 | 12078700 | OT |
| 120787004 | 12078700 | DE |
| 120787004 | 12078700 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120787004 | 12078700 | Febrile neutropenia | |
| 120787004 | 12078700 | Haematotoxicity | |
| 120787004 | 12078700 | Intracranial venous sinus thrombosis | |
| 120787004 | 12078700 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |