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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125508831 | 12550883 | 1 | I | 20160630 | 20160712 | 20160712 | EXP | PHHY2016US094073 | SANDOZ | SEITER K, AHMED N, SHAIKH A, BASKIND P, LIU D.. CLAG-BASED INDUCTION THERAPY IN PREVIOUSLY UNTREATED HIGH RISK ACUTE MYELOID LEUKEMIA PATIENTS.. LEUKEMIA RESEARCH. 2016;46:74-8 | 52.00 | YR | M | Y | 0.00000 | 20160713 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125508831 | 12550883 | 1 | PS | FILGRASTIM | FILGRASTIM | 1 | Unknown | 300 UG, QD | 125553 | 300 | UG | QD | |||||||
| 125508831 | 12550883 | 2 | SS | IDARUBICIN | IDARUBICIN | 1 | Unknown | 12 MG/M2, UNK (TIMES 3 DAYS) | 0 | 12 | MG/M**2 | ||||||||
| 125508831 | 12550883 | 3 | SS | CLADRIBINE. | CLADRIBINE | 1 | Unknown | 5 MG/M2, UNK (OVER 2HOURS) | 0 | 5 | MG/M**2 | QD | |||||||
| 125508831 | 12550883 | 4 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | 2 G/M2, QD (OVER 4 HOURS) | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125508831 | 12550883 | 1 | Acute myeloid leukaemia |
| 125508831 | 12550883 | 2 | Acute myeloid leukaemia |
| 125508831 | 12550883 | 3 | Acute myeloid leukaemia |
| 125508831 | 12550883 | 4 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125508831 | 12550883 | OT |
| 125508831 | 12550883 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125508831 | 12550883 | Pancytopenia | |
| 125508831 | 12550883 | Stenotrophomonas sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |