Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Conditions
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
Undergo allogeneic transplant
Given IV
Given IV
Given IV
Correlative studies
Given PO
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival (EFS) | EFS assessed for up to 5 years, 2 year EFS reported | 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. |
| Rate of Allogeneic HCT | Up to 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival (DFS) Among High Risk Patients | DFS assessed for up to 5 years, 2 year DFS reported | 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. |
| EFS of Arm I Compared to Arm II | EFS assessed for up to 5 years, 2 year EFS reported | 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. |
| Frequency and Severity of Toxicities | Up to 5 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of the Mutation NPM1 in Patients on This Study. | Baseline | To 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 reported | 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. |
| Prevalence of the Mutations IDH1, IDH2, TET2, DMT3A in Patients on This Study | Baseline | To 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 Study | Baseline | To estimate the cytogenetic risk distribution of patients on this study. |
| Overall Survival (OS) | OS assessed for up to 5 years, 2 year OS reported | 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. |
| Complete Response (CR) Rate | Up to 5 years | 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) |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 738 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 8 | 8 |
| Overall Study | Death | 7 | 14 | 13 |
| Overall Study | Did not start treatment | 0 | 2 | 5 |
| Overall Study | Ineligible | 2 | 6 | 8 |
| Overall Study | Other - not protocol specified | 32 | 22 | 24 |
| Overall Study | Progression/relapse | 1 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 6 | 5 |
Baseline characteristics
| Characteristic | Arm II (High-dose Cytarabine, Idarubicin) | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Total |
|---|---|---|---|---|
| Age, Continuous | 51.5 years | 48.9 years | 48.3 years | 49.8 years |
| Age, Customized < 40 years | 65 Participants | 55 Participants | 68 Participants | 188 Participants |
| Age, Customized >= 40 years | 196 Participants | 161 Participants | 193 Participants | 550 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 21 Participants | 19 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 217 Participants | 185 Participants | 226 Participants | 628 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 22 Participants | 10 Participants | 16 Participants | 48 Participants |
| Onset of Leukemia De novo | 236 Participants | 193 Participants | 236 Participants | 665 Participants |
| Onset of Leukemia Tx. related/arose from antecededent hem. disease | 25 Participants | 23 Participants | 25 Participants | 73 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 17 Participants | 19 Participants | 55 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 11 Participants | 12 Participants | 42 Participants |
| Race (NIH/OMB) White | 217 Participants | 178 Participants | 218 Participants | 613 Participants |
| Sex: Female, Male Female | 127 Participants | 102 Participants | 131 Participants | 360 Participants |
| Sex: Female, Male Male | 134 Participants | 114 Participants | 130 Participants | 378 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 126 / 261 | 114 / 259 | 103 / 211 |
| other Total, other adverse events | 249 / 261 | 254 / 259 | 206 / 211 |
| serious Total, serious adverse events | 11 / 261 | 27 / 259 | 75 / 211 |
Outcome results
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
| Arm | Measure | Value (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 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Rate of Allogeneic HCT | 65 percentage of patients |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Disease-free Survival (DFS) Among High Risk Patients | 0.30 Proportion of participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | EFS of Arm I Compared to Arm II | 0.36 Proportion of participants |
| Arm II (High-dose Cytarabine, Idarubicin) | EFS of Arm I Compared to Arm II | 0.41 Proportion of participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Diarrhea | 15 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Purpura | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Rash acneiform | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Rash maculo-papular | 11 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Rectal hemorrhage | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Rectal pain | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Renal and urinary disorders - Other, specify | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Resp, thoracic and mediastinal disorders - Other | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Respiratory failure | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Restrictive cardiomyopathy | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Salivary duct inflammation | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Scrotal infection | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Scrotal pain | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Seizure | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Sepsis | 16 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Sinus tachycardia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Sinus bradycardia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Sinusitis | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Skin and subcutaneous tissue disorders - Other | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Skin infection | 5 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Skin ulceration | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Small intestinal obstruction | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Soft tissue infection | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Sore throat | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Stomach pain | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Stroke | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Supraventricular tachycardia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Syncope | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Testicular disorder | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Thromboembolic event | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Thrombotic thrombocytopenic purpura | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Tooth infection | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Tumor lysis syndrome | 4 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Typhlitis | 8 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Upper gastrointestinal hemorrhage | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Upper respiratory infection | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Urinary incontinence | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Urinary tract infection | 5 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Urine output decreased | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Vaginal hemorrhage | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Vascular access complication | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Vasovagal reaction | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Ventricular tachycardia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Vomiting | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Weight loss | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | White blood cell decreased | 156 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Wound infection | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Acute kidney injury | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Abdominal distension | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Abdominal infection | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Abdominal pain | 4 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Acidosis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Adult respiratory distress syndrome | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Alanine aminotransferase increased | 12 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Alkaline phosphatase increased | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Alkalosis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Allergic reaction | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Anal hemorrhage | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Anal pain | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Anorectal infection | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Anal ulcer | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Anemia | 158 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Anorexia | 5 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Aspartate aminotransferase increased | 8 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Atelectasis | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Atrial fibrillation | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Atrial flutter | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Atrioventricular block complete | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Blood and lymphatic system disorders - Other | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Blood bilirubin increased | 9 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Bone infection | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Bone pain | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Bronchopulmonary hemorrhage | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Bullous dermatitis | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | CD4 lymphocytes decreased | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Cardiac arrest | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Cardiac disorders - Other, specify | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Cardiac troponin I increased | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Catheter related infection | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Chills | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Chronic kidney disease | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Cognitive disturbance | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Colitis | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Colonic hemorrhage | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Colonic perforation | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Conduction disorder | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Confusion | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Conjunctivitis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Constipation | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Constrictive pericarditis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Creatinine increased | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Death NOS | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Dehydration | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Dental caries | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Device related infection | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Disseminated intravascular coagulation | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Dry mouth | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Dry skin | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Duodenal hemorrhage | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Dyspepsia | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Dysphagia | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Dyspnea | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Edema cerebral | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Edema limbs | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Ejection fraction decreased | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Electrocardiogram QT corrected interval prolonged | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Encephalopathy | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Enterocolitis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Enterocolitis infectious | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Epistaxis | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Erythema multiforme | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Erythroderma | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Esophageal hemorrhage | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Esophageal pain | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Esophagitis | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Eye infection | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Fatigue | 14 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Febrile neutropenia | 152 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Fever | 4 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | GGT increased | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Gait disturbance | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Gastric hemorrhage | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Gastritis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Gastroesophageal reflux disease | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Gastrointestinal disorders - Other, specify | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | General disorders and admin site conditions-Other | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Generalized muscle weakness | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Genital edema | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Glucose intolerance | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Gum infection | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Headache | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Heart failure | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hematoma | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hematuria | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hepatic failure | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hepatic infection | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hepatobiliary disorders - Other, specify | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hyperglycemia | 5 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hyperhidrosis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hyperkalemia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypermagnesemia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypernatremia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypertension | 7 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hyperuricemia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypoalbuminemia | 5 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypocalcemia | 8 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypoglycemia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypokalemia | 18 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypomagnesemia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hyponatremia | 20 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypophosphatemia | 21 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypotension | 3 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Hypoxia | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Ileus | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Infections and infestations - Other, specify | 18 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Infective myositis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Injury, poison and procedural complications-Other | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Intracranial hemorrhage | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Investigations - Other, specify | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Irregular menstruation | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Jejunal obstruction | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Kidney infection | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Laryngeal edema | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Laryngeal mucositis | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Left ventricular systolic dysfunction | 2 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Leukocytosis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Lipase increased | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Lower gastrointestinal hemorrhage | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Lung infection | 21 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Lymphocyte count decreased | 89 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Menorrhagia | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Metabolism and nutrition disorders-Other, specify | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Middle ear inflammation | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Mucosal infection | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Mucositis oral | 19 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Multi-organ failure | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Musculoskeletal and connective tiss disorder-Other | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Myalgia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Nausea | 7 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Neck edema | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Nervous system disorders - Other, specify | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Neutrophil count decreased | 141 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Non-cardiac chest pain | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Oral pain | 5 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pain | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pain in extremity | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Palmar-plantar erythrodysesthesia syndrome | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Papulopustular rash | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Paresthesia | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Periorbital edema | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Peripheral sensory neuropathy | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pharyngeal mucositis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pharyngitis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Platelet count decreased | 175 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pleural effusion | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pneumonitis | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pruritus | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pulmonary edema | 1 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pericardial effusion | 0 Participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Frequency and Severity of Toxicities | Pericardial tamponade | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pericardial effusion | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Paresthesia | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pericardial tamponade | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Colonic hemorrhage | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Left ventricular systolic dysfunction | 3 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Purpura | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dyspepsia | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Multi-organ failure | 3 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Rash acneiform | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Injury, poison and procedural complications-Other | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hematoma | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Rash maculo-papular | 26 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Irregular menstruation | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dysphagia | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Rectal hemorrhage | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Colonic perforation | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Palmar-plantar erythrodysesthesia syndrome | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Rectal pain | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dyspnea | 7 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hematuria | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Renal and urinary disorders - Other, specify | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Cardiac arrest | 3 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Leukocytosis | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Resp, thoracic and mediastinal disorders - Other | 3 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Edema cerebral | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Infections and infestations - Other, specify | 21 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Peripheral sensory neuropathy | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Respiratory failure | 8 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Conduction disorder | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hepatic failure | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Restrictive cardiomyopathy | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Edema limbs | 3 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Bone pain | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Salivary duct inflammation | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Ejection fraction decreased | 6 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Musculoskeletal and connective tiss disorder-Other | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Scrotal infection | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Cardiac disorders - Other, specify | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hepatic infection | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Scrotal pain | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Lipase increased | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Electrocardiogram QT corrected interval prolonged | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Seizure | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Confusion | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Blood bilirubin increased | 15 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hepatobiliary disorders - Other, specify | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sepsis | 26 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Encephalopathy | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Jejunal obstruction | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sinus bradycardia | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sinus tachycardia | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Ileus | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pruritus | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sinusitis | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Enterocolitis | 6 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyperglycemia | 12 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Skin and subcutaneous tissue disorders - Other | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Conjunctivitis | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Lower gastrointestinal hemorrhage | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Skin infection | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Enterocolitis infectious | 4 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Myalgia | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Skin ulceration | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Infective myositis | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyperhidrosis | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Small intestinal obstruction | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Cardiac troponin I increased | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Epistaxis | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Soft tissue infection | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Constipation | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Papulopustular rash | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sore throat | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Erythema multiforme | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyperkalemia | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Stomach pain | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Bronchopulmonary hemorrhage | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Lung infection | 22 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Stroke | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Erythroderma | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pneumonitis | 4 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Supraventricular tachycardia | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Platelet count decreased | 168 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypermagnesemia | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Syncope | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Constrictive pericarditis | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Esophageal hemorrhage | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Testicular disorder | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Intracranial hemorrhage | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Nausea | 15 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Thromboembolic event | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Kidney infection | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypernatremia | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Thrombotic thrombocytopenic purpura | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Esophageal pain | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Creatinine increased | 6 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Tooth infection | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Lymphocyte count decreased | 107 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Esophagitis | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Tumor lysis syndrome | 8 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Catheter related infection | 7 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypertension | 6 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Typhlitis | 14 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Atrioventricular block complete | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Eye infection | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Upper gastrointestinal hemorrhage | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Death NOS | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pharyngeal mucositis | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Upper respiratory infection | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pleural effusion | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyperuricemia | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Urinary incontinence | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Fatigue | 18 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Blood and lymphatic system disorders - Other | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Urinary tract infection | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Menorrhagia | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Neck edema | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Urine output decreased | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Febrile neutropenia | 160 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypoalbuminemia | 8 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Vaginal hemorrhage | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pain in extremity | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dehydration | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Vascular access complication | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Fever | 7 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Chills | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Vasovagal reaction | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Laryngeal edema | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypocalcemia | 17 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Ventricular tachycardia | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | GGT increased | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dental caries | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Vomiting | 6 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Metabolism and nutrition disorders-Other, specify | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gait disturbance | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Weight loss | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Bullous dermatitis | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypoglycemia | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | White blood cell decreased | 150 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pulmonary edema | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gastric hemorrhage | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Wound infection | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Device related infection | 3 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Nervous system disorders - Other, specify | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypokalemia | 20 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Abdominal distension | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Chronic kidney disease | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gastritis | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Abdominal infection | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Diarrhea | 20 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Middle ear inflammation | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Abdominal pain | 6 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gastroesophageal reflux disease | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypomagnesemia | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Acidosis | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Bone infection | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Acute kidney injury | 5 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Investigations - Other, specify | 6 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gastrointestinal disorders - Other, specify | 5 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Adult respiratory distress syndrome | 3 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Disseminated intravascular coagulation | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Periorbital edema | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Alanine aminotransferase increased | 17 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | General disorders and admin site conditions-Other | 4 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyponatremia | 20 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Alkaline phosphatase increased | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Cognitive disturbance | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Mucosal infection | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Alkalosis | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Generalized muscle weakness | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Neutrophil count decreased | 128 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Allergic reaction | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Laryngeal mucositis | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypophosphatemia | 31 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anal hemorrhage | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dry mouth | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Genital edema | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anal pain | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Oral pain | 5 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | CD4 lymphocytes decreased | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypotension | 12 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Glucose intolerance | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anal ulcer | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dry skin | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Mucositis oral | 18 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anemia | 164 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gum infection | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anorectal infection | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Colitis | 9 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pharyngitis | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anorexia | 16 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Atrial flutter | 1 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypoxia | 4 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Aspartate aminotransferase increased | 15 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Headache | 2 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pain | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Atelectasis | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Duodenal hemorrhage | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Non-cardiac chest pain | 0 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Atrial fibrillation | 3 Participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Heart failure | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Atrial fibrillation | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sinus tachycardia | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Ileus | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Atrioventricular block complete | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Non-cardiac chest pain | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Blood and lymphatic system disorders - Other | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Blood bilirubin increased | 22 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Infections and infestations - Other, specify | 14 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Bone infection | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pharyngitis | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Bone pain | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Bronchopulmonary hemorrhage | 3 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Infective myositis | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Bullous dermatitis | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | CD4 lymphocytes decreased | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Cardiac arrest | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Injury, poison and procedural complications-Other | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Cardiac disorders - Other, specify | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Oral pain | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Cardiac troponin I increased | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Catheter related infection | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Intracranial hemorrhage | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Chills | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Chronic kidney disease | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Cognitive disturbance | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Investigations - Other, specify | 3 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Colitis | 5 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Colonic hemorrhage | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Colonic perforation | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Irregular menstruation | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Conduction disorder | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pain | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Confusion | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Conjunctivitis | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Jejunal obstruction | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Constipation | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Constrictive pericarditis | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Creatinine increased | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Kidney infection | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Death NOS | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dehydration | 3 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dental caries | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Laryngeal edema | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Device related infection | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Diarrhea | 38 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pain in extremity | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Disseminated intravascular coagulation | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dry mouth | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Laryngeal mucositis | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dry skin | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Edema limbs | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Platelet count decreased | 128 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Duodenal hemorrhage | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dyspepsia | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Left ventricular systolic dysfunction | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dysphagia | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Dyspnea | 8 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Edema cerebral | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Leukocytosis | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Palmar-plantar erythrodysesthesia syndrome | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Ejection fraction decreased | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Electrocardiogram QT corrected interval prolonged | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Lipase increased | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Encephalopathy | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Enterocolitis | 5 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Enterocolitis infectious | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Lower gastrointestinal hemorrhage | 3 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Epistaxis | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Erythema multiforme | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Erythroderma | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Lung infection | 14 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Esophageal hemorrhage | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Papulopustular rash | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Esophageal pain | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Esophagitis | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Lymphocyte count decreased | 77 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Eye infection | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Fatigue | 13 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Febrile neutropenia | 114 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Menorrhagia | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Fever | 6 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pericardial tamponade | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | GGT increased | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gait disturbance | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Metabolism and nutrition disorders-Other, specify | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gastric hemorrhage | 3 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pleural effusion | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gastritis | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gastroesophageal reflux disease | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Middle ear inflammation | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gastrointestinal disorders - Other, specify | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | General disorders and admin site conditions-Other | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Generalized muscle weakness | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Mucosal infection | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Genital edema | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Periorbital edema | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Glucose intolerance | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Gum infection | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Mucositis oral | 11 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Headache | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pruritus | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pulmonary edema | 5 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Heart failure | 3 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Purpura | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Rash acneiform | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Rash maculo-papular | 10 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hematoma | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Rectal hemorrhage | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Multi-organ failure | 5 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Rectal pain | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Renal and urinary disorders - Other, specify | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hematuria | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sinus bradycardia | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Resp, thoracic and mediastinal disorders - Other | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Respiratory failure | 14 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Restrictive cardiomyopathy | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hepatic failure | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Salivary duct inflammation | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Scrotal infection | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Scrotal pain | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hepatic infection | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Seizure | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Musculoskeletal and connective tiss disorder-Other | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sepsis | 34 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hepatobiliary disorders - Other, specify | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Peripheral sensory neuropathy | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sinusitis | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Skin and subcutaneous tissue disorders - Other | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyperglycemia | 16 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Skin infection | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Skin ulceration | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Small intestinal obstruction | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyperhidrosis | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Soft tissue infection | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Myalgia | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Sore throat | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Stomach pain | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyperkalemia | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Stroke | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Supraventricular tachycardia | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Syncope | 3 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypermagnesemia | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Testicular disorder | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Thromboembolic event | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Thrombotic thrombocytopenic purpura | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypernatremia | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Tooth infection | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Nausea | 5 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Tumor lysis syndrome | 9 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Typhlitis | 23 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypertension | 6 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Upper gastrointestinal hemorrhage | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Upper respiratory infection | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Urinary incontinence | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyperuricemia | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Urinary tract infection | 6 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Urine output decreased | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Vaginal hemorrhage | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypoalbuminemia | 8 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Vascular access complication | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Neck edema | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Vasovagal reaction | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Ventricular tachycardia | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypocalcemia | 25 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Vomiting | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pharyngeal mucositis | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Weight loss | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | White blood cell decreased | 112 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypoglycemia | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Wound infection | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Abdominal distension | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypokalemia | 24 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Abdominal infection | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Nervous system disorders - Other, specify | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Abdominal pain | 9 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Acidosis | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Acute kidney injury | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypomagnesemia | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Adult respiratory distress syndrome | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pneumonitis | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Alanine aminotransferase increased | 20 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Alkaline phosphatase increased | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hyponatremia | 9 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Alkalosis | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Allergic reaction | 2 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anal hemorrhage | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypophosphatemia | 31 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anal pain | 0 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Neutrophil count decreased | 104 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Atrial flutter | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anal ulcer | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypotension | 9 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anemia | 106 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anorectal infection | 4 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Anorexia | 12 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Aspartate aminotransferase increased | 12 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Hypoxia | 9 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Atelectasis | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Paresthesia | 1 Participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Frequency and Severity of Toxicities | Pericardial effusion | 1 Participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Complete Response (CR) Rate | 75 Percentage of participants |
| Arm II (High-dose Cytarabine, Idarubicin) | Complete Response (CR) Rate | 80 Percentage of participants |
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Complete Response (CR) Rate | 77 Percentage of participants |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Cytogenetic Risk Distribution of Patients on This Study | High risk | 22.3 percentage of participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Cytogenetic Risk Distribution of Patients on This Study | Intermediate risk | 64.2 percentage of participants |
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Cytogenetic Risk Distribution of Patients on This Study | Low risk | 13.5 percentage of participants |
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
| Arm | Measure | Value (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 |
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
| Arm | Measure | Value (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 |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Prevalence of the Mutation NPM1 in Patients on This Study. | 33 percentage of patients |
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.