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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126188231 | 12618823 | 1 | I | 20160726 | 20160803 | 20160803 | EXP | US-JNJFOC-20160723915 | JANSSEN | WINTER SS, DUNSMORE KP, DEVIDAS M, EISENBERG N, ASSELIN BL, WOOD BL, ET AL. SAFE INTEGRATION OF NELARABINE INTO INTENSIVE CHEMOTHERAPY IN NEWLY DIAGNOSED T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA: CHILDREN^S ONCOLOGY GROUP STUDY AALL0434. PEDIATRIC BLOOD CANCER 2015;62 (7):1176-1183. | 0.00 | Y | 0.00000 | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126188231 | 12618823 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | ON DAYS 1, 8 AND 15 | U | U | 50718 | 25 | MG/M**2 | LIPOSOME INJECTION | |||||
| 126188231 | 12618823 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | FOR 28 DAYS | U | 0 | 30 | MG/M**2 | UNSPECIFIED | BID | |||||
| 126188231 | 12618823 | 3 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | MAXIMUM 2 MG DAYS 1, 8, 15, 22 AND 50 | U | 0 | 1.5 | MG/M**2 | UNSPECIFIED | ||||||
| 126188231 | 12618823 | 4 | SS | DAUNORUBICIN | DAUNORUBICIN | 1 | Unknown | DAY 1,8,15 AND 22 | U | 0 | 25 | MG/M**2 | UNSPECIFIED | ||||||
| 126188231 | 12618823 | 5 | SS | PEGASPARGASE | PEGASPARGASE | 1 | Intramuscular | 2500 IU/M2, DOSEX1 DAY 4 OR 5 OR 6 | U | 0 | UNSPECIFIED | ||||||||
| 126188231 | 12618823 | 6 | SS | ARA-C | CYTARABINE | 1 | Intravenous (not otherwise specified) | INTRAVENOUS AOR SUBQ ON DAY 36-39 AND 43-46 | U | 0 | 75 | MG/M**2 | UNSPECIFIED | ||||||
| 126188231 | 12618823 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | AGE ADJUSTED DOSING; ON DAY 8 AND 29, ADDITIONALLY ON DAYS 15 AND 22, ALSO ON 1, 36 AND 43 | U | 0 | UNSPECIFIED | ||||||||
| 126188231 | 12618823 | 8 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | DAY 36 | U | 0 | 1000 | MG/M**2 | UNSPECIFIED | ||||||
| 126188231 | 12618823 | 9 | SS | TIOGUANINE | THIOGUANINE ANHYDROUS | 1 | Unknown | DAYS 36-49 | U | 0 | 60 | MG/M**2 | UNSPECIFIED | ||||||
| 126188231 | 12618823 | 10 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | DAYS 1-7 AND 15-21 | U | 0 | 5 | MG/M**2 | UNSPECIFIED | BID | |||||
| 126188231 | 12618823 | 11 | SS | NELARABINE | NELARABINE | 1 | Intravenous (not otherwise specified) | DAYS 1-5, 43-47 IN CONSOLIDATION AND 29-33 IN DELAYED INTENSIFICATION | U | 0 | 650 | MG/M**2 | UNSPECIFIED | ||||||
| 126188231 | 12618823 | 12 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | AGE ADJUSTED ON DAY 1 | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126188231 | 12618823 | 1 | T-cell type acute leukaemia |
| 126188231 | 12618823 | 2 | T-cell type acute leukaemia |
| 126188231 | 12618823 | 3 | T-cell type acute leukaemia |
| 126188231 | 12618823 | 4 | T-cell type acute leukaemia |
| 126188231 | 12618823 | 5 | T-cell type acute leukaemia |
| 126188231 | 12618823 | 6 | Product used for unknown indication |
| 126188231 | 12618823 | 7 | Central nervous system leukaemia |
| 126188231 | 12618823 | 8 | Product used for unknown indication |
| 126188231 | 12618823 | 9 | Product used for unknown indication |
| 126188231 | 12618823 | 10 | Product used for unknown indication |
| 126188231 | 12618823 | 11 | T-cell type acute leukaemia |
| 126188231 | 12618823 | 12 | Central nervous system leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126188231 | 12618823 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126188231 | 12618823 | Off label use | |
| 126188231 | 12618823 | Peripheral motor neuropathy | |
| 126188231 | 12618823 | Peripheral sensory neuropathy | |
| 126188231 | 12618823 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |