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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125259251 | 12525925 | 1 | I | 20160622 | 20160705 | 20160705 | EXP | CZ-ACCORD-042115 | ACCORD | SRAMKOVA L. GEMTUZUMAB OZOGAMICIN IN ACUTE MYELOID LEUKEMIA IN CHILDREN. ACTA MEDICINE. 2016 MAR, 76-77. | 11.00 | YR | F | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125259251 | 12525925 | 1 | PS | ETOPOSIDE. | ETOPOSIDE | 1 | RECEIVED AS ADXE REGIMEN AS INDUCTION THERAPY | Y | 74513 | ||||||||||
| 125259251 | 12525925 | 2 | SS | DAUNOXOME | DAUNORUBICIN CITRATE | 1 | RECEIVED AS ADXE REGIMEN AS INDUCTION THERAPY | Y | 0 | ||||||||||
| 125259251 | 12525925 | 3 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | INITIALLY RECEIVED DOSE 40 MG/M2 TRANSFUSION THEN RECEIVED AS ADXE REGIMEN AS INDUCTION THERAPY | Y | 0 | 40 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125259251 | 12525925 | 1 | Acute myeloid leukaemia |
| 125259251 | 12525925 | 2 | Acute myeloid leukaemia |
| 125259251 | 12525925 | 3 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125259251 | 12525925 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125259251 | 12525925 | Compartment syndrome | |
| 125259251 | 12525925 | Drug ineffective | |
| 125259251 | 12525925 | Renal failure | |
| 125259251 | 12525925 | Sepsis | |
| 125259251 | 12525925 | 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 |