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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120898463 | 12089846 | 3 | F | 20160909 | 20160218 | 20160915 | EXP | NO-SZ09-PHHY2014NO070895 | NO-FRESENIUS KABI-FK201600783 | FRESENIUS KABI | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120898463 | 12089846 | 1 | PS | CYTARABINE (Manufacturer Unknown) | CYTARABINE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 76512 | 200 | MG/M**2 | UNKNOWN | ||||||
| 120898463 | 12089846 | 2 | SS | CYTARABINE (Manufacturer Unknown) | CYTARABINE | 1 | Intrathecal | U | UNKNOWN | 76512 | 40 | MG | UNKNOWN | ||||||
| 120898463 | 12089846 | 3 | SS | ASPARAGINASE | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | 0 | 10000 | IU | UNKNOWN | ||||||||
| 120898463 | 12089846 | 4 | SS | ASPARAGINASE | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | 0 | 10 | IU | UNKNOWN | ||||||||
| 120898463 | 12089846 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | 0 | 1500 | MG/M**2 | SOLUTION FOR INJECTION | ||||||||
| 120898463 | 12089846 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intratracheal | 0 | 15 | MG | SOLUTION FOR INJECTION | ||||||||
| 120898463 | 12089846 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Intrathecal | 0 | 10 | MG | UNKNOWN | ||||||||
| 120898463 | 12089846 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 40 | MG/M**2 | UNKNOWN | ||||||||
| 120898463 | 12089846 | 9 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 0 | 1.5 | MG/M**2 | UNKNOWN | ||||||||
| 120898463 | 12089846 | 10 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 0 | 750 | MG/M**2 | |||||||||
| 120898463 | 12089846 | 11 | SS | DAUNORUBICIN | DAUNORUBICIN | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG/M**2 | UNKNOWN | ||||||||
| 120898463 | 12089846 | 12 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | 0 | 30 | MG/M**2 | UNKNOWN | ||||||||
| 120898463 | 12089846 | 13 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Oral | 0 | 35 | MG/M**2 | |||||||||
| 120898463 | 12089846 | 14 | SS | THIOGUANINE | THIOGUANINE | 1 | Intravenous (not otherwise specified) | 0 | 150 | MG/M**2 | UNKNOWN | ||||||||
| 120898463 | 12089846 | 15 | SS | G-CSF | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | 0 | 10 | UG/KG | UNKNOWN | ||||||||
| 120898463 | 12089846 | 16 | SS | L-ASPARAGINASE | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | 0 | 10 | IU |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120898463 | 12089846 | 1 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 3 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 5 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 7 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 9 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 10 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 11 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 12 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 13 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 14 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 120898463 | 12089846 | 15 | Peripheral blood stem cell apheresis |
| 120898463 | 12089846 | 16 | Precursor T-lymphoblastic lymphoma/leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120898463 | 12089846 | OT |
| 120898463 | 12089846 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120898463 | 12089846 | Febrile neutropenia | |
| 120898463 | 12089846 | Haematotoxicity | |
| 120898463 | 12089846 | 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 |