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Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia

A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy or Idarubicin With High Dose Cytarabine (IA) Versus IA With Vorinostat (NSC-701852) (IA + V) in Younger Patients With Previously Untreated Acute Myeloid Leukemia (AML)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01802333
Enrollment
754
Registered
2013-03-01
Start date
2013-02-12
Completion date
2017-06-15
Last updated
2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

Brief summary

This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cytarabine with or without vorinostat to see how well they work in treating younger patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells. It is not yet known which combination chemotherapy is more effective in treating acute myeloid leukemia.

Detailed description

PRIMARY OBJECTIVES: I. To compare event-free survival (EFS) between patients with acute myeloid leukemia (AML) who receive standard 7+3 (cytarabine and daunorubicin hydrochloride) or idarubicin and high-dose cytarabine (IA) to patients who receive IA + vorinostat. (Chemotherapy) II. To determine whether it is possible to get 60% or more of adults with high-risk AML (by cytogenetics) in first complete remission (CR1) to allogeneic hematopoietic cell transplantation (HCT). (Transplant) SECONDARY OBJECTIVES: I. To estimate the frequency and severity of toxicities of the three regimens in this patient population. (Chemotherapy) II. To estimate disease-free survival (DFS) among patients who receive transplant. (Transplant) III. To compare event-free survival (EFS) between patients who receive standard 7 + 3 to patients who receive IA. (Chemotherapy) IV. To estimate the prevalence of the mutations nucleophosmin (nucleolar phosphoprotein B23, numatrin) (NPM1), isocitrate dehydrogenase 1 (NADP+), soluble (IDH1), isocitrate dehydrogenase 2 (NADP+), mitochondrial (IDH2), tet methylcytosine dioxygenase 2 (TET2) and deoxyribonucleic acid (DNA) (cytosine-5-)-methyltransferase 3 alpha (DNMT3A) and the cytogenetic risk distribution of patients on this study and to evaluate the association between these and overall survival (OS), event-free survival (EFS), disease-free survival (DFS), and complete remission rate. (Chemotherapy/Translational Medicine) V. To compare the complete response rate, disease-free survival (DFS), and overall survival (OS) between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. (Chemotherapy) TERTIARY OBJECTIVES: I. Future planned studies will include testing of histone H3 acetylation, induction of gamma H2A histone family, member X (H2AX), analysis of reactive oxygen species (ROS) resistance and DNA methylation profiles. (Chemotherapy/Translational Medicine) OUTLINE: Patients are randomized to 1 of 3 treatment arms. INDUCTION/RE-INDUCTION: ARM I: Patients receive standard dose cytarabine intravenously (IV) continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving complete remission (CR) or complete remission with incomplete platelet recover (CRi) may proceed to allogeneic hematopoietic stem cell transplant (HSCT) or to consolidation therapy. ARM II: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy. ARM III: Patients receive vorinostat orally (PO) thrice daily (TID) on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patient previously randomized to Arm III may continue treatment without vorinostat. CONSOLIDATION: ARM I: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. ARM II: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2. ARM III: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5. (Permanently closed to accrual, effective 6/2/2015) Patient previously randomized to Arm III may continue treatment with or without vorinostat. In all arms, treatment repeats every 28 days for 4 courses or until transplant in the absence of disease progression or unacceptable toxicity. TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.

Interventions

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic transplant

DRUGCytarabine

Given IV

DRUGDaunorubicin Hydrochloride

Given IV

DRUGIdarubicin

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies

DRUGVorinostat

Given PO

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* STEP 1 - INDUCTION/RE-INDUCTION * Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML) with blood or bone marrow disease; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible; note: this protocol uses World Health Organization (WHO) diagnostic criteria for AML; patients with acute promyelocytic leukemia (APL, French-American-British \[FAB\], M3) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible; patients with known core binding factor (CBF) or fms-like tyrosine kinase 3 (FLT3) related leukemias are eligible for this study, but should preferentially be placed on National Cancer Institute (NCI)-sponsored protocols specific for these subtypes, if available * Patients must have diagnostic/pre-treatment specimens obtained within 28 days prior to registration submitted for cytogenetic (and fluorescent in situ hybridization \[FISH\] if possible) analysis to determine risk status; high risk classification will be defined as del(5q)/-5, del(7q)/-7, abn3q26 \[inv(3)/t(3;3)\], 11q23 rearrangement \[except t(9;11)\], 17p-, t(6;9), t(9;22), complex (at least 3 unrelated abnormalities \[abn\]), and monosomal karyotype (either loss of two different chromosomes or loss of one chromosome along with a structural chromosome abnormality other than add, ring and mar); karyograms and cytogenetics/FISH analysis reports must be submitted for discipline review * Patients must be chemo-naïve, i.e., not have received any prior induction chemotherapy for AML or myelodysplastic syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed; prior anthracycline therapy is allowed, but must not exceed a dose of 200 mg/m\^2 daunorubicin or equivalent; prior all-trans retinoic acid (ATRA) for suspected APL is allowed; prior methotrexate for central nervous system (CNS) involvement is allowed; patients with prior history of MDS must not have received azacitidine, decitabine, lenalidomide or vorinostat * Patients must have peripheral blood and bone marrow aspirate specimens obtained within 28 days prior to registration submitted for translational medicine; with patient consent, residuals will be banked for future research * Patients must have Zubrod performance status =\< 3 * Patients must have either echocardiogram (ECHO) or multi gated acquisition scan (MUGA) with ejection fraction \>= 45% within 28 days prior to registration * Patients must not have prolonged corrected QT (QTc) interval (\> 500 msec) determined by electrocardiogram (EKG) within 28 days prior to registration * Patients must not have cardiac disease defined as: New York Heart Association (NYHA) \> class II; patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months * Patients must not have any coexisting medical condition that is likely to interfere with study procedures or results, and must be reasonable candidates for intensive chemotherapy, in the opinion of their treating physicians * Patients who are known to be human immunodeficiency virus (HIV) positive (+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration: * Cluster of differentiation (CD) 4 cells \>= 500/mm\^3 * Viral load \< 50 copies of HIV messenger ribonucleic acid (mRNA)/mm\^3 if on combination antiretroviral therapy (cART) or \< 25,000 copies of HIV mRNA if not on cART * No zidovudine or stavudine as part of cART; patients who are HIV+ and do not meet all of these criteria are not eligible for this study * Patients with known hepatitis B or hepatitis C infection may be eligible providing they have viral load \< 800,000 IU/mL within 28 days prior to registration * Patients must be able to take oral medications * Patients must have a history and physical examination obtained within 28 days prior to registration * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Prior malignancy is allowed providing it does not require concurrent therapy; exception: active hormonal therapy is allowed * Patients must not be receiving valproic acid * All patients must be informed of the investigational nature of this study; patients or a legally authorized representative must sign and give written informed consent in accordance with institutional and federal guidelines * As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * STEP 2 - CONSOLIDATION * Patients may be registered for consolidation provided that they were eligible for the initial induction/re-induction registration and satisfy the following additional criteria: * Patients must have achieved morphologic remission (complete remission \[CR\] or complete remission with incomplete blood count recover \[CRi\]) after completion of induction or re-induction therapy; patient must remain in remission until beginning consolidation and this must be documented by bone marrow and peripheral blood examination within 28 days prior to registration to Step 2 * All non-hematologic treatment related toxicities that are deemed clinically significant by the treating physician must have resolved to =\< grade 2 * Patients must not have received allogeneic stem cell transplant

Design outcomes

Primary

MeasureTime frameDescription
Event-free Survival (EFS)EFS assessed for up to 5 years, 2 year EFS reportedEFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. 2-year EFS by arm will be estimated using the Kaplan-Meier method. EFS will be compared between Arm I and Arm III and between Arm II and Arm III using Cox proportional hazards regression.
Rate of Allogeneic HCTUp to 5 yearsThe goal of the transplant objective is to determine whether it is possible to conduct allogeneic HCT on 60% or more of adults with high-risk AML in first complete remission (alternative). If 40% or fewer of high-risk patients in CR can be transplanted, the proposed transplant support system will not be considered feasible. A one-sided binomial test compared to the null transplant rate will be conducted.

Secondary

MeasureTime frameDescription
Disease-free Survival (DFS) Among High Risk PatientsDFS assessed for up to 5 years, 2 year DFS reportedDFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery). DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. 2-year DFS for high risk patients will be estimated using the Kaplan-Meier method.
EFS of Arm I Compared to Arm IIEFS assessed for up to 5 years, 2 year EFS reportedEFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. A two-sided test of the hazard ratio (HR) of 7:3: IA (versus the null hypothesis of HR =1) will be done using a proportional hazards regression model with the stratification factors included as covariates. 2-year EFS by arm will be estimated using the Kaplan-Meier method.
Frequency and Severity of ToxicitiesUp to 5 yearsNumber of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event.

Other

MeasureTime frameDescription
Prevalence of the Mutation NPM1 in Patients on This Study.BaselineTo estimate the prevalence of the mutation NPM1 in this patient population.
Disease-free Survival (DFS)DFS assessed for up to 5 years, 2 year DFS reportedTo compare the disease-free survival (DFS) between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery) . DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. 2-year DFS by arm will be estimated using the Kaplan-Meier method.
Prevalence of the Mutations IDH1, IDH2, TET2, DMT3A in Patients on This StudyBaselineTo estimate the prevalence of these mutations in this patient population. This objective will be analyzed as funding allows.
Cytogenetic Risk Distribution of Patients on This StudyBaselineTo estimate the cytogenetic risk distribution of patients on this study.
Overall Survival (OS)OS assessed for up to 5 years, 2 year OS reportedTo compare OS between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. OS is calculated for all patients from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. 2-year OS by arm will be estimated using the Kaplan-Meier method.
Complete Response (CR) RateUp to 5 yearsTo compare the complete response rate between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. Complete response is defined as: ANC \>= 1,000/mcl, platelet count \>= 100,000/mcl, \< 5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease (no requirements for marrow cellularity or hemoglobin concentration)

Countries

Canada, United States

Participant flow

Participants by arm

ArmCount
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)
INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy. CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies
261
Arm II (High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy. CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2. TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant Cytarabine: Given IV Idarubicin: Given IV Laboratory Biomarker Analysis: Correlative studies
261
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)
INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy. CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5. TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplant Cytarabine: Given IV Idarubicin: Given IV Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
216
Total738

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event188
Overall StudyDeath71413
Overall StudyDid not start treatment025
Overall StudyIneligible268
Overall StudyOther - not protocol specified322224
Overall StudyProgression/relapse130
Overall StudyWithdrawal by Subject665

Baseline characteristics

CharacteristicArm II (High-dose Cytarabine, Idarubicin)Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Total
Age, Continuous51.5 years48.9 years48.3 years49.8 years
Age, Customized
< 40 years
65 Participants55 Participants68 Participants188 Participants
Age, Customized
>= 40 years
196 Participants161 Participants193 Participants550 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
22 Participants21 Participants19 Participants62 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
217 Participants185 Participants226 Participants628 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
22 Participants10 Participants16 Participants48 Participants
Onset of Leukemia
De novo
236 Participants193 Participants236 Participants665 Participants
Onset of Leukemia
Tx. related/arose from antecededent hem. disease
25 Participants23 Participants25 Participants73 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants3 Participants3 Participants6 Participants
Race (NIH/OMB)
Asian
4 Participants7 Participants6 Participants17 Participants
Race (NIH/OMB)
Black or African American
19 Participants17 Participants19 Participants55 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants2 Participants3 Participants
Race (NIH/OMB)
Unknown or Not Reported
19 Participants11 Participants12 Participants42 Participants
Race (NIH/OMB)
White
217 Participants178 Participants218 Participants613 Participants
Sex: Female, Male
Female
127 Participants102 Participants131 Participants360 Participants
Sex: Female, Male
Male
134 Participants114 Participants130 Participants378 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
126 / 261114 / 259103 / 211
other
Total, other adverse events
249 / 261254 / 259206 / 211
serious
Total, serious adverse events
11 / 26127 / 25975 / 211

Outcome results

Primary

Event-free Survival (EFS)

EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. 2-year EFS by arm will be estimated using the Kaplan-Meier method. EFS will be compared between Arm I and Arm III and between Arm II and Arm III using Cox proportional hazards regression.

Time frame: EFS assessed for up to 5 years, 2 year EFS reported

Population: Eligible patients

ArmMeasureValue (NUMBER)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Event-free Survival (EFS)0.36 Proportion of participants
Arm II (High-dose Cytarabine, Idarubicin)Event-free Survival (EFS)0.41 Proportion of participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Event-free Survival (EFS)0.37 Proportion of participants
Comparison: Arm I was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.p-value: 0.84Regression, Cox
Comparison: Arm II was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.p-value: 0.42Regression, Cox
Primary

Rate of Allogeneic HCT

The goal of the transplant objective is to determine whether it is possible to conduct allogeneic HCT on 60% or more of adults with high-risk AML in first complete remission (alternative). If 40% or fewer of high-risk patients in CR can be transplanted, the proposed transplant support system will not be considered feasible. A one-sided binomial test compared to the null transplant rate will be conducted.

Time frame: Up to 5 years

Population: Eligible patients with high-risk AML who achieved CR or CRi, regardless of treatment arm.

ArmMeasureValue (NUMBER)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Rate of Allogeneic HCT65 percentage of patients
p-value: <0.0001Exact binomial test, 1-sided
Secondary

Disease-free Survival (DFS) Among High Risk Patients

DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery). DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. 2-year DFS for high risk patients will be estimated using the Kaplan-Meier method.

Time frame: DFS assessed for up to 5 years, 2 year DFS reported

Population: Eligible, high risk patients, regardless of treatment arm.

ArmMeasureValue (NUMBER)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Disease-free Survival (DFS) Among High Risk Patients0.30 Proportion of participants
Secondary

EFS of Arm I Compared to Arm II

EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. A two-sided test of the hazard ratio (HR) of 7:3: IA (versus the null hypothesis of HR =1) will be done using a proportional hazards regression model with the stratification factors included as covariates. 2-year EFS by arm will be estimated using the Kaplan-Meier method.

Time frame: EFS assessed for up to 5 years, 2 year EFS reported

Population: Eligible patients

ArmMeasureValue (NUMBER)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)EFS of Arm I Compared to Arm II0.36 Proportion of participants
Arm II (High-dose Cytarabine, Idarubicin)EFS of Arm I Compared to Arm II0.41 Proportion of participants
Comparison: Arm I was compared with Arm II using a two-sided test of the null hypothesis (HR=1).p-value: 0.52Regression, Cox
Secondary

Frequency and Severity of Toxicities

Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event.

Time frame: Up to 5 years

Population: Eligible patients who started treatment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDiarrhea15 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPurpura0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesRash acneiform1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesRash maculo-papular11 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesRectal hemorrhage1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesRectal pain1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesRenal and urinary disorders - Other, specify0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesResp, thoracic and mediastinal disorders - Other1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesRespiratory failure3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesRestrictive cardiomyopathy1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSalivary duct inflammation1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesScrotal infection0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesScrotal pain0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSeizure1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSepsis16 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSinus tachycardia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSinus bradycardia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSinusitis2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSkin and subcutaneous tissue disorders - Other0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSkin infection5 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSkin ulceration0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSmall intestinal obstruction1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSoft tissue infection1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSore throat1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesStomach pain1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesStroke0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSupraventricular tachycardia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesSyncope2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesTesticular disorder0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesThromboembolic event1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesThrombotic thrombocytopenic purpura3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesTooth infection1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesTumor lysis syndrome4 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesTyphlitis8 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesUpper gastrointestinal hemorrhage1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesUpper respiratory infection2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesUrinary incontinence0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesUrinary tract infection5 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesUrine output decreased0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesVaginal hemorrhage0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesVascular access complication0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesVasovagal reaction0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesVentricular tachycardia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesVomiting3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesWeight loss2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesWhite blood cell decreased156 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesWound infection1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAcute kidney injury2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAbdominal distension1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAbdominal infection1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAbdominal pain4 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAcidosis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAdult respiratory distress syndrome1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAlanine aminotransferase increased12 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAlkaline phosphatase increased2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAlkalosis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAllergic reaction0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAnal hemorrhage0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAnal pain0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAnorectal infection0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAnal ulcer0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAnemia158 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAnorexia5 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAspartate aminotransferase increased8 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAtelectasis0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAtrial fibrillation0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAtrial flutter0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesAtrioventricular block complete0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesBlood and lymphatic system disorders - Other1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesBlood bilirubin increased9 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesBone infection1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesBone pain0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesBronchopulmonary hemorrhage1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesBullous dermatitis0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesCD4 lymphocytes decreased1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesCardiac arrest1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesCardiac disorders - Other, specify1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesCardiac troponin I increased0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesCatheter related infection3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesChills1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesChronic kidney disease0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesCognitive disturbance0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesColitis3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesColonic hemorrhage2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesColonic perforation0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesConduction disorder1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesConfusion0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesConjunctivitis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesConstipation0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesConstrictive pericarditis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesCreatinine increased1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDeath NOS1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDehydration1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDental caries1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDevice related infection1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDisseminated intravascular coagulation2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDry mouth0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDry skin0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDuodenal hemorrhage1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDyspepsia1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDysphagia1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesDyspnea3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEdema cerebral0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEdema limbs0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEjection fraction decreased2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesElectrocardiogram QT corrected interval prolonged0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEncephalopathy0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEnterocolitis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEnterocolitis infectious1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEpistaxis2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesErythema multiforme1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesErythroderma0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEsophageal hemorrhage0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEsophageal pain1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEsophagitis3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesEye infection0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesFatigue14 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesFebrile neutropenia152 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesFever4 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGGT increased3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGait disturbance0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGastric hemorrhage0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGastritis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGastroesophageal reflux disease1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGastrointestinal disorders - Other, specify1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGeneral disorders and admin site conditions-Other0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGeneralized muscle weakness2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGenital edema0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGlucose intolerance1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesGum infection1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHeadache2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHeart failure3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHematoma0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHematuria0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHepatic failure1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHepatic infection1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHepatobiliary disorders - Other, specify1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHyperglycemia5 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHyperhidrosis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHyperkalemia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypermagnesemia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypernatremia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypertension7 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHyperuricemia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypoalbuminemia5 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypocalcemia8 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypoglycemia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypokalemia18 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypomagnesemia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHyponatremia20 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypophosphatemia21 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypotension3 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesHypoxia2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesIleus0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesInfections and infestations - Other, specify18 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesInfective myositis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesInjury, poison and procedural complications-Other1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesIntracranial hemorrhage0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesInvestigations - Other, specify1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesIrregular menstruation1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesJejunal obstruction0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesKidney infection0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesLaryngeal edema1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesLaryngeal mucositis0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesLeft ventricular systolic dysfunction2 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesLeukocytosis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesLipase increased0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesLower gastrointestinal hemorrhage0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesLung infection21 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesLymphocyte count decreased89 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesMenorrhagia1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesMetabolism and nutrition disorders-Other, specify1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesMiddle ear inflammation1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesMucosal infection1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesMucositis oral19 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesMulti-organ failure1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesMusculoskeletal and connective tiss disorder-Other0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesMyalgia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesNausea7 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesNeck edema0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesNervous system disorders - Other, specify0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesNeutrophil count decreased141 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesNon-cardiac chest pain1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesOral pain5 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPain1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPain in extremity1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPalmar-plantar erythrodysesthesia syndrome0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPapulopustular rash0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesParesthesia0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPeriorbital edema0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPeripheral sensory neuropathy0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPharyngeal mucositis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPharyngitis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPlatelet count decreased175 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPleural effusion1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPneumonitis1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPruritus0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPulmonary edema1 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPericardial effusion0 Participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Frequency and Severity of ToxicitiesPericardial tamponade0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPericardial effusion0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesParesthesia0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPericardial tamponade0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesColonic hemorrhage0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLeft ventricular systolic dysfunction3 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPurpura1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDyspepsia0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMulti-organ failure3 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRash acneiform1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesInjury, poison and procedural complications-Other0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHematoma1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRash maculo-papular26 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesIrregular menstruation0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDysphagia1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRectal hemorrhage0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesColonic perforation0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPalmar-plantar erythrodysesthesia syndrome2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRectal pain0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDyspnea7 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHematuria2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRenal and urinary disorders - Other, specify1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCardiac arrest3 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLeukocytosis1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesResp, thoracic and mediastinal disorders - Other3 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEdema cerebral0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesInfections and infestations - Other, specify21 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPeripheral sensory neuropathy0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRespiratory failure8 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConduction disorder0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHepatic failure0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRestrictive cardiomyopathy0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEdema limbs3 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBone pain1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSalivary duct inflammation0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEjection fraction decreased6 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMusculoskeletal and connective tiss disorder-Other1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesScrotal infection0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCardiac disorders - Other, specify1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHepatic infection1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesScrotal pain0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLipase increased0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesElectrocardiogram QT corrected interval prolonged2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSeizure0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConfusion2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBlood bilirubin increased15 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHepatobiliary disorders - Other, specify0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSepsis26 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEncephalopathy1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesJejunal obstruction0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSinus bradycardia0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSinus tachycardia2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesIleus1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPruritus1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSinusitis0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEnterocolitis6 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyperglycemia12 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSkin and subcutaneous tissue disorders - Other2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConjunctivitis0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLower gastrointestinal hemorrhage1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSkin infection1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEnterocolitis infectious4 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMyalgia0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSkin ulceration0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesInfective myositis0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyperhidrosis1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSmall intestinal obstruction0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCardiac troponin I increased1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEpistaxis1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSoft tissue infection0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConstipation1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPapulopustular rash1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSore throat2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesErythema multiforme0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyperkalemia1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesStomach pain0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBronchopulmonary hemorrhage1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLung infection22 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesStroke1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesErythroderma0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPneumonitis4 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSupraventricular tachycardia1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPlatelet count decreased168 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypermagnesemia1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSyncope2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConstrictive pericarditis0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEsophageal hemorrhage0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesTesticular disorder1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesIntracranial hemorrhage0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNausea15 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesThromboembolic event0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesKidney infection1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypernatremia0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesThrombotic thrombocytopenic purpura0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEsophageal pain1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCreatinine increased6 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesTooth infection0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLymphocyte count decreased107 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEsophagitis2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesTumor lysis syndrome8 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCatheter related infection7 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypertension6 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesTyphlitis14 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAtrioventricular block complete1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEye infection1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUpper gastrointestinal hemorrhage0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDeath NOS1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPharyngeal mucositis0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUpper respiratory infection1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPleural effusion0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyperuricemia1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUrinary incontinence0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesFatigue18 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBlood and lymphatic system disorders - Other1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUrinary tract infection2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMenorrhagia0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNeck edema0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUrine output decreased0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesFebrile neutropenia160 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypoalbuminemia8 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVaginal hemorrhage0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPain in extremity0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDehydration0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVascular access complication2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesFever7 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesChills0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVasovagal reaction1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLaryngeal edema0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypocalcemia17 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVentricular tachycardia1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGGT increased2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDental caries0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVomiting6 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMetabolism and nutrition disorders-Other, specify1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGait disturbance0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesWeight loss0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBullous dermatitis2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypoglycemia0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesWhite blood cell decreased150 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPulmonary edema2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGastric hemorrhage2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesWound infection0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDevice related infection3 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNervous system disorders - Other, specify1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypokalemia20 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAbdominal distension0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesChronic kidney disease2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGastritis0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAbdominal infection1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDiarrhea20 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMiddle ear inflammation0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAbdominal pain6 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGastroesophageal reflux disease0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypomagnesemia1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAcidosis1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBone infection0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAcute kidney injury5 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesInvestigations - Other, specify6 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGastrointestinal disorders - Other, specify5 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAdult respiratory distress syndrome3 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDisseminated intravascular coagulation1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPeriorbital edema1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAlanine aminotransferase increased17 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGeneral disorders and admin site conditions-Other4 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyponatremia20 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAlkaline phosphatase increased2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCognitive disturbance0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMucosal infection0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAlkalosis1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGeneralized muscle weakness1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNeutrophil count decreased128 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAllergic reaction0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLaryngeal mucositis0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypophosphatemia31 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnal hemorrhage0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDry mouth1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGenital edema0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnal pain1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesOral pain5 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCD4 lymphocytes decreased1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypotension12 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGlucose intolerance0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnal ulcer0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDry skin2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMucositis oral18 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnemia164 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGum infection0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnorectal infection0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesColitis9 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPharyngitis0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnorexia16 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAtrial flutter1 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypoxia4 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAspartate aminotransferase increased15 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHeadache2 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPain0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAtelectasis0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDuodenal hemorrhage0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNon-cardiac chest pain0 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAtrial fibrillation3 Participants
Arm II (High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHeart failure2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAtrial fibrillation1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSinus tachycardia2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesIleus2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAtrioventricular block complete0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNon-cardiac chest pain1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBlood and lymphatic system disorders - Other0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBlood bilirubin increased22 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesInfections and infestations - Other, specify14 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBone infection0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPharyngitis0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBone pain0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBronchopulmonary hemorrhage3 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesInfective myositis0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesBullous dermatitis0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCD4 lymphocytes decreased0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCardiac arrest2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesInjury, poison and procedural complications-Other0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCardiac disorders - Other, specify1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesOral pain0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCardiac troponin I increased0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCatheter related infection4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesIntracranial hemorrhage1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesChills0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesChronic kidney disease0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCognitive disturbance1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesInvestigations - Other, specify3 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesColitis5 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesColonic hemorrhage1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesColonic perforation1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesIrregular menstruation0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConduction disorder0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPain0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConfusion0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConjunctivitis0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesJejunal obstruction1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConstipation0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesConstrictive pericarditis0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesCreatinine increased4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesKidney infection0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDeath NOS0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDehydration3 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDental caries0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLaryngeal edema0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDevice related infection0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDiarrhea38 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPain in extremity1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDisseminated intravascular coagulation1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDry mouth0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLaryngeal mucositis1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDry skin0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEdema limbs2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPlatelet count decreased128 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDuodenal hemorrhage0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDyspepsia0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLeft ventricular systolic dysfunction0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDysphagia0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesDyspnea8 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEdema cerebral1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLeukocytosis1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPalmar-plantar erythrodysesthesia syndrome1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEjection fraction decreased4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesElectrocardiogram QT corrected interval prolonged2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLipase increased2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEncephalopathy0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEnterocolitis5 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEnterocolitis infectious4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLower gastrointestinal hemorrhage3 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEpistaxis2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesErythema multiforme0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesErythroderma1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLung infection14 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEsophageal hemorrhage1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPapulopustular rash0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEsophageal pain0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEsophagitis1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesLymphocyte count decreased77 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesEye infection0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesFatigue13 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesFebrile neutropenia114 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMenorrhagia0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesFever6 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPericardial tamponade1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGGT increased4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGait disturbance1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMetabolism and nutrition disorders-Other, specify0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGastric hemorrhage3 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPleural effusion1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGastritis0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGastroesophageal reflux disease0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMiddle ear inflammation0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGastrointestinal disorders - Other, specify1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGeneral disorders and admin site conditions-Other1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGeneralized muscle weakness2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMucosal infection1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGenital edema1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPeriorbital edema0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGlucose intolerance0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesGum infection0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMucositis oral11 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHeadache4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPruritus1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPulmonary edema5 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHeart failure3 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPurpura0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRash acneiform0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRash maculo-papular10 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHematoma0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRectal hemorrhage0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMulti-organ failure5 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRectal pain1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRenal and urinary disorders - Other, specify0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHematuria0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSinus bradycardia1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesResp, thoracic and mediastinal disorders - Other2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRespiratory failure14 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesRestrictive cardiomyopathy0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHepatic failure0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSalivary duct inflammation0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesScrotal infection1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesScrotal pain1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHepatic infection0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSeizure1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMusculoskeletal and connective tiss disorder-Other1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSepsis34 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHepatobiliary disorders - Other, specify1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPeripheral sensory neuropathy1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSinusitis0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSkin and subcutaneous tissue disorders - Other1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyperglycemia16 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSkin infection4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSkin ulceration1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSmall intestinal obstruction0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyperhidrosis0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSoft tissue infection0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesMyalgia1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSore throat2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesStomach pain0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyperkalemia1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesStroke1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSupraventricular tachycardia1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesSyncope3 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypermagnesemia0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesTesticular disorder0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesThromboembolic event0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesThrombotic thrombocytopenic purpura1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypernatremia2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesTooth infection0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNausea5 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesTumor lysis syndrome9 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesTyphlitis23 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypertension6 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUpper gastrointestinal hemorrhage1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUpper respiratory infection2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUrinary incontinence1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyperuricemia1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUrinary tract infection6 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesUrine output decreased1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVaginal hemorrhage2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypoalbuminemia8 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVascular access complication1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNeck edema1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVasovagal reaction1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVentricular tachycardia0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypocalcemia25 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesVomiting4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPharyngeal mucositis0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesWeight loss2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesWhite blood cell decreased112 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypoglycemia1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesWound infection0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAbdominal distension1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypokalemia24 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAbdominal infection1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNervous system disorders - Other, specify0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAbdominal pain9 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAcidosis2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAcute kidney injury4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypomagnesemia2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAdult respiratory distress syndrome4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPneumonitis2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAlanine aminotransferase increased20 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAlkaline phosphatase increased1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHyponatremia9 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAlkalosis2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAllergic reaction2 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnal hemorrhage1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypophosphatemia31 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnal pain0 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesNeutrophil count decreased104 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAtrial flutter1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnal ulcer1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypotension9 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnemia106 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnorectal infection4 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAnorexia12 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAspartate aminotransferase increased12 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesHypoxia9 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesAtelectasis1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesParesthesia1 Participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Frequency and Severity of ToxicitiesPericardial effusion1 Participants
Other Pre-specified

Complete Response (CR) Rate

To compare the complete response rate between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. Complete response is defined as: ANC \>= 1,000/mcl, platelet count \>= 100,000/mcl, \< 5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease (no requirements for marrow cellularity or hemoglobin concentration)

Time frame: Up to 5 years

Population: Eligible patients

ArmMeasureValue (NUMBER)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Complete Response (CR) Rate75 Percentage of participants
Arm II (High-dose Cytarabine, Idarubicin)Complete Response (CR) Rate80 Percentage of participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Complete Response (CR) Rate77 Percentage of participants
Other Pre-specified

Cytogenetic Risk Distribution of Patients on This Study

To estimate the cytogenetic risk distribution of patients on this study.

Time frame: Baseline

Population: Eligible patients with known cytogenetic risk at baseline

ArmMeasureGroupValue (NUMBER)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Cytogenetic Risk Distribution of Patients on This StudyHigh risk22.3 percentage of participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Cytogenetic Risk Distribution of Patients on This StudyIntermediate risk64.2 percentage of participants
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Cytogenetic Risk Distribution of Patients on This StudyLow risk13.5 percentage of participants
Other Pre-specified

Disease-free Survival (DFS)

To compare the disease-free survival (DFS) between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery) . DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. 2-year DFS by arm will be estimated using the Kaplan-Meier method.

Time frame: DFS assessed for up to 5 years, 2 year DFS reported

Population: Eligible patients

ArmMeasureValue (NUMBER)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Disease-free Survival (DFS)0.48 Proportion of participants
Arm II (High-dose Cytarabine, Idarubicin)Disease-free Survival (DFS)0.51 Proportion of participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Disease-free Survival (DFS)0.46 Proportion of participants
Other Pre-specified

Overall Survival (OS)

To compare OS between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. OS is calculated for all patients from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. 2-year OS by arm will be estimated using the Kaplan-Meier method.

Time frame: OS assessed for up to 5 years, 2 year OS reported

Population: Eligible patients

ArmMeasureValue (NUMBER)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Overall Survival (OS)0.56 Proportion of participants
Arm II (High-dose Cytarabine, Idarubicin)Overall Survival (OS)0.59 Proportion of participants
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)Overall Survival (OS)0.58 Proportion of participants
Other Pre-specified

Prevalence of the Mutation NPM1 in Patients on This Study.

To estimate the prevalence of the mutation NPM1 in this patient population.

Time frame: Baseline

Population: Eligible patients with known NPM1 status at baseline

ArmMeasureValue (NUMBER)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)Prevalence of the Mutation NPM1 in Patients on This Study.33 percentage of patients
Other Pre-specified

Prevalence of the Mutations IDH1, IDH2, TET2, DMT3A in Patients on This Study

To estimate the prevalence of these mutations in this patient population. This objective will be analyzed as funding allows.

Time frame: Baseline

Population: There was not sufficient funding to test patients for IDH1, IDH2, TET2, or DMT3A. Therefore, this objective was not completed.

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026