The Safety Rates Drug Report

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Drug     Injury     Quarter    

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
126695431 12669543 1 I 20160816 20160819 20160819 EXP US-JNJFOC-20160814287 JANSSEN MATLOUB Y, STORK L, ASSELIN B, HUNGER SP, BOROWITZ M, JONES T, ET AL. OUTCOME OF CHILDREN WITH STANDARD-RISK T-LINEAGE ACUTE LYMPHOBLASTIC LEUKEMIA-COMPARISON AMONG DIFFERENT TREATMENT STRATEGIES. PEDIATRIC BLOOD AND CANCER 2016;63 (2):255-261. 0.00 Y 0.00000 20160819 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
126695431 12669543 1 PS DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE 1 Unknown U U 50718 UNSPECIFIED
126695431 12669543 2 SS METHOTREXATE. METHOTREXATE 1 Unknown U 0 UNSPECIFIED
126695431 12669543 3 SS ASPARAGINASE ASPARAGINASE 1 Unknown U 0 UNSPECIFIED
126695431 12669543 4 SS VINCRISTINE VINCRISTINE 1 Unknown U 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126695431 12669543 1 Acute lymphocytic leukaemia
126695431 12669543 2 Acute lymphocytic leukaemia
126695431 12669543 3 Acute lymphocytic leukaemia
126695431 12669543 4 Acute lymphocytic leukaemia

Outcome of event

Event ID CASEID OUTC COD
126695431 12669543 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
126695431 12669543 Mucosal inflammation
126695431 12669543 Off label use
126695431 12669543 Product use issue
126695431 12669543 Venoocclusive liver disease

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found