The Safety Rates Drug Report

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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
125461751 12546175 1 I 20160628 20160711 20160711 EXP CZ-TEVA-673087ISR TEVA SRAMKOVA L. GEMTUZUMAB OZOGAMICIN V LECBE AKUTNI MYELOIDNI LEUKEMIE U DETI/GEMTUZUMAB OZOGAMICIN IN TREATMENT OF PEDIATRIC PATIENT WITH ACUTE MYELOID LEUKEMIA. ACTA MEDICINAE. 2016 JAN 01;3/2016:76-77. 11.00 YR F Y 0.00000 20160711 MD CZ CZ

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
125461751 12546175 1 PS ETOPOSIDE. ETOPOSIDE 1 74284
125461751 12546175 2 SS DAUNOXOME DAUNORUBICIN CITRATE 1 0
125461751 12546175 3 SS Cytosine arabinoside CYTARABINE 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125461751 12546175 1 Acute myeloid leukaemia
125461751 12546175 2 Acute myeloid leukaemia
125461751 12546175 3 Acute myeloid leukaemia

Outcome of event

Event ID CASEID OUTC COD
125461751 12546175 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125461751 12546175 Acute kidney injury
125461751 12546175 Compartment syndrome
125461751 12546175 Leukaemic infiltration renal
125461751 12546175 Sepsis
125461751 12546175 Tumour lysis syndrome

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

no results found

Therapies reported

no results found