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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127977751 | 12797775 | 1 | I | 20160917 | 20160924 | 20160930 | 20160930 | EXP | US-TAKEDA-2016MPI008335 | TAKEDA | 18.00 | YR | F | Y | 51.30000 | KG | 20160929 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127977751 | 12797775 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Intravenous (not otherwise specified) | UNK | D | 21602 | INJECTION | ||||||||
| 127977751 | 12797775 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Intravenous (not otherwise specified) | 1 MG/M2, UNK | D | 21602 | 1 | MG/M**2 | INJECTION | ||||||
| 127977751 | 12797775 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Intravenous (not otherwise specified) | 1.3 MG/M2, UNK | D | 21602 | 1.3 | MG/M**2 | INJECTION | ||||||
| 127977751 | 12797775 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | UNK | D | 0 | |||||||||
| 127977751 | 12797775 | 5 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 5 MG/M2, UNK | D | 0 | 5 | MG/M**2 | |||||||
| 127977751 | 12797775 | 6 | SS | Doxorubicin | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | 25 MG/M2, UNK | D | 0 | 25 | MG/M**2 | |||||||
| 127977751 | 12797775 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | UNK | D | 0 | |||||||||
| 127977751 | 12797775 | 8 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | UNK | D | 0 | |||||||||
| 127977751 | 12797775 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 5000 MG/M2, UNK | D | 0 | 5000 | MG/M**2 | |||||||
| 127977751 | 12797775 | 10 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | UNK | D | 0 | |||||||||
| 127977751 | 12797775 | 11 | SS | Pegaspargase | PEGASPARGASE | 1 | Intravenous (not otherwise specified) | UNK | D | 0 | |||||||||
| 127977751 | 12797775 | 12 | SS | Pegaspargase | PEGASPARGASE | 1 | Intravenous (not otherwise specified) | UNK, UNK | D | 0 | |||||||||
| 127977751 | 12797775 | 13 | SS | Pegaspargase | PEGASPARGASE | 1 | Intravenous (not otherwise specified) | UNK | D | 0 | |||||||||
| 127977751 | 12797775 | 14 | SS | Vincristine | VINCRISTINE | 1 | Intravenous (not otherwise specified) | UNK | D | 0 | |||||||||
| 127977751 | 12797775 | 15 | SS | Vincristine | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 1.5 MG/M2, UNK | D | 0 | 1.5 | MG/M**2 | |||||||
| 127977751 | 12797775 | 16 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 1000 MG/M2, UNK | D | 0 | 1000 | MG/M**2 | SOLUTION FOR INJECTION/INFUSION | ||||||
| 127977751 | 12797775 | 17 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | UNK | D | 0 | INJECTION | ||||||||
| 127977751 | 12797775 | 18 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | 75 MG/M2, UNK | D | 0 | 75 | MG/M**2 | INJECTION | ||||||
| 127977751 | 12797775 | 19 | SS | Daunorubicin | DAUNORUBICIN | 1 | Intravenous (not otherwise specified) | UNK | D | 0 | INTRAVENOUS INFUSION | ||||||||
| 127977751 | 12797775 | 20 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Oral | 60 MG/M2, UNK | D | 0 | 60 | MG/M**2 | |||||||
| 127977751 | 12797775 | 21 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Oral | 25 MG/M2, UNK | D | 0 | 25 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127977751 | 12797775 | 1 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 127977751 | 12797775 | 4 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 127977751 | 12797775 | 6 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 127977751 | 12797775 | 7 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 127977751 | 12797775 | 11 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 127977751 | 12797775 | 14 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 127977751 | 12797775 | 16 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 127977751 | 12797775 | 17 | Precursor T-lymphoblastic lymphoma/leukaemia |
| 127977751 | 12797775 | 20 | Precursor T-lymphoblastic lymphoma/leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127977751 | 12797775 | HO |
| 127977751 | 12797775 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127977751 | 12797775 | Acute kidney injury | |
| 127977751 | 12797775 | Blood creatine phosphokinase increased | |
| 127977751 | 12797775 | Febrile neutropenia | |
| 127977751 | 12797775 | Hypocalcaemia | |
| 127977751 | 12797775 | Hypotension | |
| 127977751 | 12797775 | Pyrexia | |
| 127977751 | 12797775 | Respiratory failure | |
| 127977751 | 12797775 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 127977751 | 12797775 | 1 | 20151217 | 0 | ||
| 127977751 | 12797775 | 3 | 20160829 | 20160916 | 0 | |
| 127977751 | 12797775 | 4 | 20151217 | 0 | ||
| 127977751 | 12797775 | 5 | 20160829 | 20160916 | 0 | |
| 127977751 | 12797775 | 6 | 20160829 | 20160913 | 0 | |
| 127977751 | 12797775 | 7 | 20151217 | 0 | ||
| 127977751 | 12797775 | 9 | 20160829 | 0 | ||
| 127977751 | 12797775 | 10 | 20160829 | 20160829 | 0 | |
| 127977751 | 12797775 | 11 | 20151217 | 0 | ||
| 127977751 | 12797775 | 13 | 20160829 | 20160916 | 0 | |
| 127977751 | 12797775 | 14 | 20151217 | 0 | ||
| 127977751 | 12797775 | 15 | 20160913 | 0 | ||
| 127977751 | 12797775 | 16 | 20160302 | 0 | ||
| 127977751 | 12797775 | 17 | 20151217 | 0 | ||
| 127977751 | 12797775 | 18 | 20160311 | 0 | ||
| 127977751 | 12797775 | 19 | 20151217 | 20160107 | 0 | |
| 127977751 | 12797775 | 21 | 20160808 | 0 |