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 |