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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98030124 | 9803012 | 4 | F | 20160630 | 20140108 | 20160708 | EXP | US-JNJFOC-20131218301 | JANSSEN | JABBOUR E, KANTARJIAN HM, THOMAS DA, SASAKI K, GARCIA-MANERO G, GARRIS R, ET AL. PHASE II STUDY OF THE HYPER-CVAD REGIMEN IN COMBINATION WITH OFATUMUMAB AS FRONTLINE THERAPY FOR ADULTS WITH CD-20 POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). BLOOD 06-DEC-2014;124 (21). JABBOUR E, HAGOP K, THOMAS D, GARCIA-MANERO G, HOEHN D, GARRIS R, ET AL. PHASE II STUDY OF THE HYPER-CVAD REGIMEN IN COMBINATION WITH OFATUMUMAB AS FRONTLINE THERAPY FOR ADULTS WITH CD-20 POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) | 0.00 | Y | 0.00000 | 20160708 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98030124 | 9803012 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | ODD COURSES 1, 3, 5, 7 | U | U | 50718 | LIPOSOME INJECTION | |||||||
| 98030124 | 9803012 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | ODD COURSES 1, 3, 5, 7 | U | 0 | UNSPECIFIED | ||||||||
| 98030124 | 9803012 | 3 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | ODD COURSES 1, 3, 5, 7 | U | 0 | UNSPECIFIED | ||||||||
| 98030124 | 9803012 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | ODD COURSES 1, 3, 5, 7 | U | 0 | UNSPECIFIED | ||||||||
| 98030124 | 9803012 | 5 | SS | OFATUMUMAB | OFATUMUMAB | 1 | Unknown | COURSES 1, 3, AND 4 | U | 0 | UNSPECIFIED | ||||||||
| 98030124 | 9803012 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | EVEN COURSES 2, 4, 6, 8 | U | 0 | UNSPECIFIED | ||||||||
| 98030124 | 9803012 | 7 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 98030124 | 9803012 | 8 | SS | PONATINIB | PONATINIB | 1 | Oral | DAILY FOR THE FIRST 14 DAYS OF CYCLE 1 THEN CONTINUOUSLY FOR THE SUBSEQUENT 7 CYCLES | U | 0 | 45 | MG | UNSPECIFIED | ||||||
| 98030124 | 9803012 | 9 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | ADMINISTERED DURING THE FIRST 4 CYCLES | U | 0 | UNSPECIFIED | ||||||||
| 98030124 | 9803012 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98030124 | 9803012 | 1 | Acute lymphocytic leukaemia |
| 98030124 | 9803012 | 2 | Acute lymphocytic leukaemia |
| 98030124 | 9803012 | 3 | Acute lymphocytic leukaemia |
| 98030124 | 9803012 | 4 | Acute lymphocytic leukaemia |
| 98030124 | 9803012 | 5 | Acute lymphocytic leukaemia |
| 98030124 | 9803012 | 6 | Acute lymphocytic leukaemia |
| 98030124 | 9803012 | 7 | Acute lymphocytic leukaemia |
| 98030124 | 9803012 | 8 | Acute lymphocytic leukaemia |
| 98030124 | 9803012 | 9 | Acute lymphocytic leukaemia |
| 98030124 | 9803012 | 10 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98030124 | 9803012 | OT |
| 98030124 | 9803012 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98030124 | 9803012 | Blood bilirubin increased | |
| 98030124 | 9803012 | Febrile neutropenia | |
| 98030124 | 9803012 | Haemorrhage intracranial | |
| 98030124 | 9803012 | Liver function test abnormal | |
| 98030124 | 9803012 | Multiple organ dysfunction syndrome | |
| 98030124 | 9803012 | Myocardial infarction | |
| 98030124 | 9803012 | Neuropathy peripheral | |
| 98030124 | 9803012 | Neutrophil count abnormal | |
| 98030124 | 9803012 | Pancreatitis | |
| 98030124 | 9803012 | Platelet count abnormal | |
| 98030124 | 9803012 | Product use issue | |
| 98030124 | 9803012 | Pulmonary embolism | |
| 98030124 | 9803012 | Rash | |
| 98030124 | 9803012 | Renal vein thrombosis | |
| 98030124 | 9803012 | Sepsis | |
| 98030124 | 9803012 | Septic shock |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |