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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126015511 | 12601551 | 1 | I | 20150203 | 20160728 | 20160728 | EXP | CA-JAZZ-2015-CA-022934 | JAZZ | 0.00 | Y | 0.00000 | 20160728 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126015511 | 12601551 | 1 | PS | Asparaginase | ASPARAGINASE | 1 | Intramuscular | U | 125359 | INJECTION | |||||||||
| 126015511 | 12601551 | 2 | SS | Asparaginase | ASPARAGINASE | 1 | U | 125359 | INJECTION | ||||||||||
| 126015511 | 12601551 | 3 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Oral | 50 MG/M2, UNK | U | 0 | 50 | MG/M**2 | |||||||
| 126015511 | 12601551 | 4 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | U | 0 | |||||||||||
| 126015511 | 12601551 | 5 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | 40 MG, UNK | U | 0 | 40 | MG | |||||||
| 126015511 | 12601551 | 6 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | 40 MG, UNK | U | 0 | 40 | MG | |||||||
| 126015511 | 12601551 | 7 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 30 MG/M2, UNK | U | 0 | 30 | MG/M**2 | |||||||
| 126015511 | 12601551 | 8 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 30 MG/M2, UNK | U | 0 | 30 | MG/M**2 | |||||||
| 126015511 | 12601551 | 9 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126015511 | 12601551 | 10 | SS | GLEEVEC | IMATINIB MESYLATE | 1 | Oral | 400 MG, QD | U | 0 | 400 | MG | |||||||
| 126015511 | 12601551 | 11 | SS | GLEEVEC | IMATINIB MESYLATE | 1 | Unknown | 400 MG, QD | U | 0 | 400 | MG | |||||||
| 126015511 | 12601551 | 12 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intrathecal | 15 MG, UNK | U | 0 | 15 | MG | |||||||
| 126015511 | 12601551 | 13 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | 15 MG, UNK | U | 0 | 15 | MG | |||||||
| 126015511 | 12601551 | 14 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | U | 0 | ||||||||||
| 126015511 | 12601551 | 15 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | U | 0 | |||||||||||
| 126015511 | 12601551 | 16 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 4000 MG/M2, UNK | U | 0 | 4000 | MG/M**2 | |||||||
| 126015511 | 12601551 | 17 | SS | METHOTREXATE. | METHOTREXATE | 1 | U | 0 | |||||||||||
| 126015511 | 12601551 | 18 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG, QID | U | 0 | 10 | MG | |||||||
| 126015511 | 12601551 | 19 | SS | PREDNISONE. | PREDNISONE | 1 | U | 0 | |||||||||||
| 126015511 | 12601551 | 20 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | Intravenous (not otherwise specified) | 2 MG, UNK | U | 0 | 2 | MG | |||||||
| 126015511 | 12601551 | 21 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | Unknown | 2 MG, UNK | U | 0 | 2 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126015511 | 12601551 | 1 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 2 | Chromosome analysis abnormal |
| 126015511 | 12601551 | 3 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 4 | Chromosome analysis abnormal |
| 126015511 | 12601551 | 5 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 6 | Chromosome analysis abnormal |
| 126015511 | 12601551 | 7 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 8 | Chromosome analysis abnormal |
| 126015511 | 12601551 | 9 | Off label use |
| 126015511 | 12601551 | 10 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 11 | Chromosome analysis abnormal |
| 126015511 | 12601551 | 12 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 13 | Chromosome analysis abnormal |
| 126015511 | 12601551 | 14 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 15 | Chromosome analysis abnormal |
| 126015511 | 12601551 | 16 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 17 | Chromosome analysis abnormal |
| 126015511 | 12601551 | 18 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 19 | Chromosome analysis abnormal |
| 126015511 | 12601551 | 20 | Acute lymphocytic leukaemia |
| 126015511 | 12601551 | 21 | Chromosome analysis abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126015511 | 12601551 | OT |
| 126015511 | 12601551 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126015511 | 12601551 | Multiple organ dysfunction syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |