Leukemia, Myeloid, Acute
Conditions
Keywords
glasdegib;, untreated;, Hedgehog Inhibitor
Brief summary
Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).
Detailed description
Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated. Assignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations. Study B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML. Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).
Interventions
DRUGglasdegib
Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization. Following consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first. Daily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.
DRUGdaunorubicin + cytarabine
'7+3' (cytarabine 100 mg/m2, IV for 7 days by continuous infusion and daunorubicin 60 mg/m2 for 3 days). If a second induction is needed, Investigators may choose either a 5 day cytarabine continuous infusion plus daunorubicin for 2 days ('5+2') or a 7 day cytarabine continuous infusion plus daunorubicin for 3 days ('7+3');
DRUGazacitidine
Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.
DRUGPlacebo
Matching placebo (PO) given on Day 1 and is to continue up to 2 years post randomization. Following consolidation therapy, placebo will be administered daily for up to 2 years after randomization or until they have MRD negative disease, whichever comes first. Daily placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.
DRUGcytarabine
Consolidation with single agent cytarabine 3 g/m2 IV for adults \<60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.
PROCEDUREHSCT
If required, and done per standard of care post Induction(s).
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind study.
Intervention model description
Randomized, double-blind, multi-center, placebo controlled study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated): 1. Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD). * AML after previous cytotoxic therapy or radiation (secondary AML). 2. 18 years of age (In Japan, 20 years of age). 3. Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy. * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome). * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution. 4. QTc interval 470 msec using the Fridericia correction (QTcF). 5. All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib. 6. Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening. 7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later. 8. Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy; 2. Have medically confirmed ovarian failure; or 3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. 9. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision. 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow \[BM\] assessments).
Exclusion criteria
Subjects with any of the following characteristics/conditions will not be included in the study: 1. Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification). 2. AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation. 3. Subjects with known active CNS leukemia. 4. Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation. 5. Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support. 6. Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis. 7. Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as \<50 bpms. 8. Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML. 9. Subjects with left ventricular ejection fraction (LVEF) \<50% are excluded from the Intensive Chemotherapy Study only. 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only. 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules. 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers. 13. Concurrent administration of herbal preparations. 14. Major surgery or radiation within 4 weeks of starting study treatment. 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin. * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol. 16. Known active drug or alcohol abuse. 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 18. Pregnant females or breastfeeding female subjects. 19. Known recent or active suicidal ideation or behavior. 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Study: Overall Survival (OS) | Baseline up to 25 months | OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact. |
| Non-intensive Study: Overall Survival (OS) | Baseline up to 25 months | OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | Complete remission (CR) was defined based on 2017 European LeukemiaNet (ELN) recommendations. CR: Bone marrow blasts \<5 percentage (%); absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) greater than equal to (\>=) 1.0\*10\^9/Liter (L); platelet count \>=100\*10\^9/L. CRMRD-neg: CR with negativity for a genetic marker by reverse transcription quantitative polymerase chain reaction (RT-qPCR), or CR with negativity by Multiparameter Flow Cytometry (MFC). |
| Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC. |
| Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC. |
| Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC. |
| Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 2 years | CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC less than (\<) 1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutropenia \<1.0\*10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. |
| Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 3 years | CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \<1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutrophil \<0.5\*10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. |
| Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | Day 1 up to maximum of 2 years | MLFS was defined based on 2017 ELN recommendations. MLFS: MRD (positive or unknown), bone marrow blasts \<5%, no hematologic recovery required, marrow should not be aplastic, at least 200 cells enumerated or cellularity absence of extramedullary disease \>=10%, and absence of blasts with Auer rods. |
| Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | Day 1 up to maximum of 3 years | MLFS was defined based on 2017 ELN recommendations. MLFS: MRD (positive or unknown), bone marrow blasts \<5%, no hematologic recovery required, marrow should not be aplastic, at least 200 cells enumerated or cellularity absence of extramedullary disease \>=10%, and absence of blasts with Auer rods. |
| Intensive Study: Percentage of Participants With Partial Remission (PR) | Day 1 up to maximum of 2 years | PR was defined based on 2017 ELN recommendations. PR: MRD (positive or unknown); bone marrow blasts - decrease to 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%; neutrophil count \>=1.0\*10\^9/L; and platelets count \>=100\*10\^9/L. |
| Non-intensive Study: Percentage of Participants With Partial Remission (PR) | Day 1 up to maximum of 3 years | PR was defined based on 2017 ELN recommendations. PR: MRD (positive or unknown); bone marrow blasts - decrease to 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%; neutrophil count \>=1.0\*10\^9/L; and platelets count \>=100\*10\^9/L. |
| Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) | Day 1 up to maximum of 3 years | CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods. |
| Intensive Study: Duration of Response (DoRi) | From date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause (maximum up to 2 years) | DoRi: only defined for participants who have ever achieved CRi or better (included CR as well) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. CRi: not qualifying for CR, neutropenia \<1.0\*10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. Participants last known to be alive who were free from relapse after CRi or better were censored at the date of last disease assessment that verifies their status. |
| Non-intensive Study: Duration of Response (DoRi) or (DoRh) | From date of first achieving CRi/CRh or better to the date of relapse/disease progression after CRi/CRh or better or death due to any cause (maximum up to 3 years) | DoRi: only defined for participants who have ever achieved CRi or better (included CR and CRh) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. DoRh: participants who had ever achieved CRh or better (included CR) on study as the time from date of first achieving CRh or better to the date of disease progression, or relapse after CRh or better, or death due to any cause. CRi: not qualifying for CR, neutrophil \<0.5\*10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods. |
| Non-intensive Study: Time to Response | From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years) | TTRi:Participants who achieved CRi or better, as the time from date of randomization to first documentation of response(CRi or better).TTRh:Participants who achieved CRh or better, as the time from date of randomization to first documentation of response(CRh or better). CRi:not qualifying for CR, neutrophil\<0.5\*10\^9/L or platelets\<50\*10\^9, absence of extramedullary disease,absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods. |
| Intensive Study: Event-free Survival (EFS) | From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 2 years) | EFS: Time from the date of randomization to the date of treatment failure (TF), relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. |
| Non-intensive Study: Participants Global Impression of Symptoms (PGIS) | Day 1 up to maximum of 3 years | PGIS: is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time. It uses a 4-point Likert scale as follows: In the last 24 hours, symptoms are: 1-absent (no symptoms), 2-mild, 3- moderate, 4=severe. |
| Non-intensive Study: Event-free Survival (EFS) | From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 3 years) | EFS: Time from the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. |
| Intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score | Day 1 up to maximum of 2 years | MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). The 13 core symptoms and 6 core interference items had highest frequency and/or severity in participants with various cancers and treatment types. It was measured at severity of symptoms and related interference at their worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = not present or did not interfere and 10 = worst or interfered completely. |
| Non-intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score | Day 1 up to maximum of 3 years | MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). The 13 core symptoms and 6 core interference items had highest frequency and/or severity in participants with various cancers and treatment types. It was measured at severity of symptoms and related interference at their worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = not present or did not interfere and 10 = worst or interfered completely. |
| Intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score | Day 1 up to maximum of 2 years | EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), the EuroQoL visual analogue scale (EQ-VAS). EQ-5D: descriptive system measures a participant's health state on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participant is asked to indicate his/her health state by rating each dimension on a 5-level scale (1=no problem, 5=extreme problem). This rating resulted in a 1-digit number expressing the level selected for that dimension. The digits for the 5 dimensions were combined in a 5-digit number describing the respondent's health state. The EQ-5D index scores ranges from 0 to 1, with 0=worst health state and 1=perfect health. |
| Non-intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score | Day 1 up to maximum of 3 years | EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ-5D: descriptive system measures a participant's health state on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participant is asked to indicate his/her health state by rating each dimension on a 5-level scale (1=no problem, 5=extreme problem). This rating resulted in a 1-digit number expressing the level selected for that dimension. The digits for the 5 dimensions were combined in a 5-digit number describing the respondent's health state. The EQ-5D index scores ranges from 0 to 1, with 0=worst health state and 1=perfect health. |
| Intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS) | Day 1 up to maximum of 2 years | EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ VAS records the respondent's self-rated health on a 20-cm vertical, VAS from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Non-intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS) | Day 1 up to maximum of 3 years | EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ VAS records the respondent's self-rated health on a 20-cm vertical, VAS from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Intensive Study: Participants Global Impression of Symptoms (PGIS) | Day 1 up to maximum of 2 years | PGIS: is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time. It uses a 4-point Likert scale as follows: In the last 24 hours, symptoms are: 1-absent (no symptoms), 2-mild, 3- moderate, 4=severe. |
| Intensive Study: Participants Global Impression of Change (PGIC) | Day 1 up to maximum of 2 years | PGIC: a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 7-point Likert scale anchored by (1) 'very much improved' to (7) 'very much worse', with (4) =' no change'. The PGIC is a measure of participant rating of global improvement and satisfaction with treatment. |
| Non-intensive Study: Participants Global Impression of Change (PGIC) | Day 1 up to maximum of 3 years | PGIC: a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 7-point Likert scale anchored by (1) 'very much improved' to (7) 'very much worse', with (4) =' no change'. The PGIC is a measure of participant rating of global improvement and satisfaction with treatment. |
| Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 2 years | AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. AEs included SAEs and all non-SAEs. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event. |
| Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 3 years | AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. AEs included SAEs and all non-SAEs. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event. |
| Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 2 years | A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event. |
| Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 3 years | A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. NCI CTCAE v4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event. |
| Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 2 years | Hematology laboratory test included: anemia, hemoglobin increased, international normalized ratio (INR) increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell decreased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for hematology laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported. |
| Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 3 years | Hematology laboratory test included: anemia, hemoglobin increased, INR increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell decreased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for hematology laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported. |
| Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 2 years | Chemistry laboratory test included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, chronic kidney disease, creatine phosphokinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for chemistry laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported. |
| Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 3 years | Chemistry laboratory test included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, chronic kidney disease, CPK increased, creatinine increased, GGT increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for chemistry laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported. |
| Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 2 years | Coagulation laboratory test included: activated partial thromboplastin time prolonged, and INR increased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 0= no abnormality; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for coagulation were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported. |
| Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Day 1 up to maximum of 3 years | Coagulation laboratory test included: activated partial thromboplastin time prolonged, and INR increased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 0= no abnormality; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for coagulation were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported. |
| Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire | Post-baseline up to Week 8 | MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). Fatigue was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 numeric rating scale (NRS), where 0 = not present and 10 = as bad as you can imagine. Percentage of participants who had improvement in fatigue symptoms reported in this outcome measure. |
| Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Pre-dose: Cycle 1 Day 15 and Cycle 2 Day 1 | Ctrough of Glasdegib was measured in ng/mL. |
| Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | Day 1 up to maximum of 2 years | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of \<=450 to \>500 msec (post-baseline) were summarized. Number of participants with shift from baseline for QTc were assessed. Only those QTc parameters in which at least 1 participant had data were reported. |
| Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | Day 1 up to maximum of 3 years | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of \<=450 to \>500 msec (post-baseline) were summarized. Number of participants with shift from baseline for QTc were assessed. Only those QTc parameters in which at least 1 participant had data were reported. |
| Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Induction, Day 10+/-1: pre-dose, 1, 4 hour (hr); Consolidation phase, Day 1: pre-dose, 1, 4 hr | Ctrough of Glasdegib was measured in nanogram per milliliter (ng/mL). |
| Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12 | Post-baseline up to Week 12 | MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). Fatigue was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = not present and 10 = as bad as you can imagine. Percentage of participants who had improvement in fatigue symptoms reported in this outcome measure. |
Countries
Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Poland, Romania, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
This study evaluated glasdegib in intensive and non-intensive chemotherapy populations. Intensive study: Glasdegib was studied in combination with cytarabine and daunorubicin for the treatment of adult participants with previously untreated acute myeloid leukemia (AML). Non-intensive study: Glasdegib was studied in combination with azacitidine for the treatment of adult participants with previously untreated AML who were not candidates for intensive induction chemotherapy.
Pre-assignment details
Inadvertently 1 participant was enrolled twice into the study resulting in enrollment number as 730. However, a total of 729 participants were randomized and received treatment in the study. Although participation of participants was terminated by the sponsor, the study was considered completed as participants were fully enrolled as planned.
Participants by arm
| Arm | Count |
|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year). | 201 |
| Intensive Study: Placebo + Cytarabine + Daunorubicin Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year). | 203 |
| Non-intensive Study: Glasdegib + Azacitidine Participants received chemotherapy with azacitidine 75 mg/m\^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participant refusal or death, whichever occurred first. Participants also were to receive glasdegib 100 mg PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib unless 2 consecutive negative MRD assessments (3 year). | 163 |
| Non-intensive Study: Placebo + Azacitidine Participants received chemotherapy with azacitidine 75 mg/m\^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participants refusal or death, whichever occurred first. Participants also received glasdegib 100 mg tablet matching placebo PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib matching placebo unless 2 consecutive negative MRD assessments (2.44 year). | 162 |
| Total | 729 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 90 | 87 | 117 | 113 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 3 |
| Overall Study | Other | 2 | 3 | 1 | 0 |
| Overall Study | Study participation terminated by Sponsor | 93 | 91 | 26 | 31 |
| Overall Study | Withdrawal by Subject | 15 | 20 | 6 | 9 |
Baseline characteristics
| Characteristic | Total | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Glasdegib + Azacitidine | Non-intensive Study: Placebo + Azacitidine |
|---|---|---|---|---|---|
| Age, Continuous | 63.63 years STANDARD_DEVIATION 13.79 | 56.55 years STANDARD_DEVIATION 12.6 | 55.38 years STANDARD_DEVIATION 13.61 | 73.19 years STANDARD_DEVIATION 7.17 | 73.14 years STANDARD_DEVIATION 6.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 59 Participants | 19 Participants | 12 Participants | 12 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 616 Participants | 166 Participants | 171 Participants | 140 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 54 Participants | 16 Participants | 20 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 218 Participants | 66 Participants | 57 Participants | 51 Participants | 44 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 3 Participants | 3 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 66 Participants | 20 Participants | 20 Participants | 14 Participants | 12 Participants |
| Race (NIH/OMB) White | 429 Participants | 110 Participants | 123 Participants | 97 Participants | 99 Participants |
| Sex: Female, Male Female | 354 Participants | 71 Participants | 97 Participants | 97 Participants | 89 Participants |
| Sex: Female, Male Male | 375 Participants | 130 Participants | 106 Participants | 66 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 90 / 201 | 88 / 203 | 117 / 163 | 113 / 162 |
| other Total, other adverse events | 194 / 198 | 195 / 201 | 154 / 162 | 148 / 160 |
| serious Total, serious adverse events | 86 / 198 | 92 / 201 | 117 / 162 | 124 / 160 |
Outcome results
Primary
Intensive Study: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.
Time frame: Baseline up to 25 months
Population: FA set included all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Overall Survival (OS) | 17.3 months |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Overall Survival (OS) | 20.4 months |
Comparison: Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio less than (\<) 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2 compared to Placebo + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2.p-value: 0.657995% CI: [0.755, 1.532]Log Rank
Primary
Non-intensive Study: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.
Time frame: Baseline up to 25 months
Population: FA set included all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Overall Survival (OS) | 10.3 months |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Overall Survival (OS) | 10.6 months |
Comparison: Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO QD + Azacitidine compared to Placebo + Azacitidinep-value: 0.595595% CI: [0.775, 1.388]Log Rank
Secondary
Intensive Study: Duration of Response (DoRi)
DoRi: only defined for participants who have ever achieved CRi or better (included CR as well) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. CRi: not qualifying for CR, neutropenia \<1.0\*10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. Participants last known to be alive who were free from relapse after CRi or better were censored at the date of last disease assessment that verifies their status.
Time frame: From date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause (maximum up to 2 years)
Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, DORi was not collected, analyzed and reported.
Secondary
Intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score
EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), the EuroQoL visual analogue scale (EQ-VAS). EQ-5D: descriptive system measures a participant's health state on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participant is asked to indicate his/her health state by rating each dimension on a 5-level scale (1=no problem, 5=extreme problem). This rating resulted in a 1-digit number expressing the level selected for that dimension. The digits for the 5 dimensions were combined in a 5-digit number describing the respondent's health state. The EQ-5D index scores ranges from 0 to 1, with 0=worst health state and 1=perfect health.
Time frame: Day 1 up to maximum of 2 years
Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EQ-5D-5L was not collected, analyzed and reported.
Secondary
Intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS)
EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ VAS records the respondent's self-rated health on a 20-cm vertical, VAS from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Day 1 up to maximum of 2 years
Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EQ-VAS was not collected, analyzed and reported.
Secondary
Intensive Study: Event-free Survival (EFS)
EFS: Time from the date of randomization to the date of treatment failure (TF), relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L.
Time frame: From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 2 years)
Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EFS was not collected, analyzed and reported.
Secondary
Intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score
MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). The 13 core symptoms and 6 core interference items had highest frequency and/or severity in participants with various cancers and treatment types. It was measured at severity of symptoms and related interference at their worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = not present or did not interfere and 10 = worst or interfered completely.
Time frame: Day 1 up to maximum of 2 years
Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, MDASI-AML/MDS was not collected, analyzed and reported.
Secondary
Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03
AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. AEs included SAEs and all non-SAEs. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.
Time frame: Day 1 up to maximum of 2 years
Population: Safety Analysis (SA) set included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | AEs | 196 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | SAEs | 86 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Grade 3 or 4 AE | 173 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Grade 5 AE | 16 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Grade 5 AE | 20 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | AEs | 198 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Grade 3 or 4 AE | 169 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | SAEs | 92 Participants |
Secondary
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Chemistry laboratory test included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, chronic kidney disease, creatine phosphokinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for chemistry laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Time frame: Day 1 up to maximum of 2 years
Population: SA set included all participants who received at least one dose of study drug. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specific rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 8 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 173 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 190 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 16 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 20 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 15 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 196 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 161 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 187 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Creatinine increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 188 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 185 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 175 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 5 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Creatinine increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 7 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 184 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 5 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 190 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 8 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 8 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 193 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypercalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 155 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 41 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypercalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 191 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 190 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 174 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 177 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 5 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 17 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 15 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 4 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 153 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade | 33 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 182 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 194 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 184 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 13 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 192 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 186 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 9 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 189 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 188 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 19 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 166 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Creatinine increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 192 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Creatinine increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 6 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 7 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 11 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypercalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypercalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 192 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 183 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 10 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 194 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 184 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 196 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 185 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 8 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 189 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 194 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 159 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 37 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 187 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 188 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 8 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 153 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade | 33 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
Secondary
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Coagulation laboratory test included: activated partial thromboplastin time prolonged, and INR increased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 0= no abnormality; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for coagulation were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Time frame: Day 1 up to maximum of 2 years
Population: SA set included all participants who received at least one dose of study drug. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specific rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Missing (baseline grade) to Grade 0 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Missing (baseline grade) to Grade 1 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 0 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 3 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 1 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Missing (baseline grade) to Grade 0 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Missing (baseline grade) to Grade 1 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Missing (baseline grade) to Grade 2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 0 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 3 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 0 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 1 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 3 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 3 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Missing (baseline grade) to Grade 0 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Missing (baseline grade) to Grade 2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Missing (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 3 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 0 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 0 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 1 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 0 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 1 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 3 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 1 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Missing (baseline grade) to Grade 0 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 1 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Missing (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
Secondary
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of \<=450 to \>500 msec (post-baseline) were summarized. Number of participants with shift from baseline for QTc were assessed. Only those QTc parameters in which at least 1 participant had data were reported.
Time frame: Day 1 up to maximum of 2 years
Population: SA set included all participants who received at least one dose of study drug. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to <=450 msec (post-baseline) | 51 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >450-<=480 msec (post-baseline) | 64 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >480-<=500 msec (post-baseline) | 18 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >500 msec (post-baseline) | 11 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to <=450 msec (post-baseline) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >450-<=480 msec (post-baseline) | 20 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >480-<=500 msec (post-baseline) | 16 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >500 msec (post-baseline) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >450-<=480 msec (post-baseline) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >480-<=500 msec (post-baseline) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >500 msec (post-baseline) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >500 msec (baseline) to >500 msec (post-baseline) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to <=450 msec (post-baseline) | 116 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >450-<=480 msec (post-baseline) | 50 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >480-<=500 msec (post-baseline) | 8 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >500 msec (post-baseline) | 5 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450-<=480 msec (baseline) to <=450 msec (post-baseline) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450-<=480 msec (baseline) to >450-<=480 msec (post-baseline) | 5 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450-<=480 msec (baseline) to >500 msec (post-baseline) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >480-<=500 msec (baseline) to >480-<=500 msec (post-baseline) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450-<=480 msec (baseline) to >450-<=480 msec (post-baseline) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to <=450 msec (post-baseline) | 71 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >500 msec (post-baseline) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >450-<=480 msec (post-baseline) | 63 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >500 msec (post-baseline) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >480-<=500 msec (post-baseline) | 11 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >500 msec (baseline) to >500 msec (post-baseline) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >500 msec (post-baseline) | 6 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >480-<=500 msec (baseline) to >480-<=500 msec (post-baseline) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to <=450 msec (post-baseline) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to <=450 msec (post-baseline) | 132 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >450-<=480 msec (post-baseline) | 17 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450-<=480 msec (baseline) to <=450 msec (post-baseline) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >480-<=500 msec (post-baseline) | 10 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >450-<=480 msec (post-baseline) | 39 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >500 msec (post-baseline) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450-<=480 msec (baseline) to >500 msec (post-baseline) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >450-<=480 msec (post-baseline) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >480-<=500 msec (post-baseline) | 10 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >480-<=500 msec (post-baseline) | 1 Participants |
Secondary
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Hematology laboratory test included: anemia, hemoglobin increased, international normalized ratio (INR) increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell decreased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for hematology laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Time frame: Day 1 up to maximum of 2 years
Population: SA set included all participants who received at least one dose of study drug. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 194 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 21 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 160 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 11 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 185 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 6 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 4 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 85 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 105 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 98 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 97 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 155 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 37 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 27 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 113 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 4 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 52 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 73 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 194 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 79 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 14 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 156 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 106 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 26 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 152 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 9 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 35 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 6 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 100 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 180 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 103 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 95 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
Secondary
Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03
A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.
Time frame: Day 1 up to maximum of 2 years
Population: SA set included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Treatment related AEs | 181 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Treatment related SAEs | 48 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Grade 3 or 4 AE | 161 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Grade 5 AE | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Grade 5 AE | 8 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Treatment related AEs | 188 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Grade 3 or 4 AE | 149 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Treatment related SAEs | 60 Participants |
Secondary
Intensive Study: Participants Global Impression of Change (PGIC)
PGIC: a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 7-point Likert scale anchored by (1) 'very much improved' to (7) 'very much worse', with (4) =' no change'. The PGIC is a measure of participant rating of global improvement and satisfaction with treatment.
Time frame: Day 1 up to maximum of 2 years
Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, PGIC was not collected, analyzed and reported.
Secondary
Intensive Study: Participants Global Impression of Symptoms (PGIS)
PGIS: is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time. It uses a 4-point Likert scale as follows: In the last 24 hours, symptoms are: 1-absent (no symptoms), 2-mild, 3- moderate, 4=severe.
Time frame: Day 1 up to maximum of 2 years
Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, PGIS was not collected, analyzed and reported.
Secondary
Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire
MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). Fatigue was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 numeric rating scale (NRS), where 0 = not present and 10 = as bad as you can imagine. Percentage of participants who had improvement in fatigue symptoms reported in this outcome measure.
Time frame: Post-baseline up to Week 8
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire | 17.41 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire | 17.24 Percentage of participants |
p-value: 0.5095Mantel Haenszel
Secondary
Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg)
CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC.
Time frame: Day 1 up to maximum of 2 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg) | 49.3 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg) | 47.3 Percentage of participants |
Secondary
Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)
CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC less than (\<) 1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutropenia \<1.0\*10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods.
Time frame: Day 1 up to maximum of 2 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | 1.5 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | 5.4 Percentage of participants |
Secondary
Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)
Complete remission (CR) was defined based on 2017 European LeukemiaNet (ELN) recommendations. CR: Bone marrow blasts \<5 percentage (%); absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) greater than equal to (\>=) 1.0\*10\^9/Liter (L); platelet count \>=100\*10\^9/L. CRMRD-neg: CR with negativity for a genetic marker by reverse transcription quantitative polymerase chain reaction (RT-qPCR), or CR with negativity by Multiparameter Flow Cytometry (MFC).
Time frame: Day 1 up to maximum of 2 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | 5.0 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | 5.4 Percentage of participants |
Secondary
Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)
MLFS was defined based on 2017 ELN recommendations. MLFS: MRD (positive or unknown), bone marrow blasts \<5%, no hematologic recovery required, marrow should not be aplastic, at least 200 cells enumerated or cellularity absence of extramedullary disease \>=10%, and absence of blasts with Auer rods.
Time frame: Day 1 up to maximum of 2 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | 1.5 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | 2.0 Percentage of participants |
Secondary
Intensive Study: Percentage of Participants With Partial Remission (PR)
PR was defined based on 2017 ELN recommendations. PR: MRD (positive or unknown); bone marrow blasts - decrease to 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%; neutrophil count \>=1.0\*10\^9/L; and platelets count \>=100\*10\^9/L.
Time frame: Day 1 up to maximum of 2 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Partial Remission (PR) | 5.0 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Intensive Study: Percentage of Participants With Partial Remission (PR) | 4.4 Percentage of participants |
Secondary
Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib
Ctrough of Glasdegib was measured in nanogram per milliliter (ng/mL).
Time frame: Induction, Day 10+/-1: pre-dose, 1, 4 hour (hr); Consolidation phase, Day 1: pre-dose, 1, 4 hr
Population: Analysis population included all participants who were treated and who had at least 1 value of analyte concentration of Glasdegib available. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specific time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Induction Day 10 | 413.54 ng/ml | Geometric Coefficient of Variation 125 |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Consolidation 1, Day 1 | 245.48 ng/ml | Geometric Coefficient of Variation 80 |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Consolidation 2, Day 1 | 259.79 ng/ml | Geometric Coefficient of Variation 122 |
Secondary
Non-intensive Study: Duration of Response (DoRi) or (DoRh)
DoRi: only defined for participants who have ever achieved CRi or better (included CR and CRh) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. DoRh: participants who had ever achieved CRh or better (included CR) on study as the time from date of first achieving CRh or better to the date of disease progression, or relapse after CRh or better, or death due to any cause. CRi: not qualifying for CR, neutrophil \<0.5\*10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods.
Time frame: From date of first achieving CRi/CRh or better to the date of relapse/disease progression after CRi/CRh or better or death due to any cause (maximum up to 3 years)
Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, DORi and DoRh was not collected, analyzed and reported.
Secondary
Non-intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score
EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ-5D: descriptive system measures a participant's health state on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participant is asked to indicate his/her health state by rating each dimension on a 5-level scale (1=no problem, 5=extreme problem). This rating resulted in a 1-digit number expressing the level selected for that dimension. The digits for the 5 dimensions were combined in a 5-digit number describing the respondent's health state. The EQ-5D index scores ranges from 0 to 1, with 0=worst health state and 1=perfect health.
Time frame: Day 1 up to maximum of 3 years
Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EQ-5D-5L was not collected, analyzed and reported.
Secondary
Non-intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS)
EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ VAS records the respondent's self-rated health on a 20-cm vertical, VAS from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Day 1 up to maximum of 3 years
Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EQ-VAS was not collected, analyzed and reported.
Secondary
Non-intensive Study: Event-free Survival (EFS)
EFS: Time from the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L.
Time frame: From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 3 years)
Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EFS was not collected, analyzed and reported.
Secondary
Non-intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score
MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). The 13 core symptoms and 6 core interference items had highest frequency and/or severity in participants with various cancers and treatment types. It was measured at severity of symptoms and related interference at their worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = not present or did not interfere and 10 = worst or interfered completely.
Time frame: Day 1 up to maximum of 3 years
Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, MDASI-AML/MDS was not collected, analyzed and reported.
Secondary
Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03
AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. AEs included SAEs and all non-SAEs. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.
Time frame: Day 1 up to maximum of 3 years
Population: SA set included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | AEs | 161 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | SAEs | 117 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Grade 3 or 4 AE | 106 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Grade 5 AE | 50 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Grade 5 AE | 52 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | AEs | 158 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | Grade 3 or 4 AE | 100 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 | SAEs | 124 Participants |
Secondary
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Chemistry laboratory test included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, chronic kidney disease, CPK increased, creatinine increased, GGT increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for chemistry laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Time frame: Day 1 up to maximum of 3 years
Population: SA set included all participants who received at least one dose of study drug. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specific rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 151 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 6 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 154 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 155 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 129 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 23 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 151 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 6 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 135 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 24 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 141 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade | 12 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 152 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 6 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 159 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 152 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 157 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 130 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 28 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 9 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 147 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Creatinine increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 153 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Creatinine increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 7 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypercalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypercalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 156 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 147 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 8 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 155 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 155 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 158 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypercalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 158 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 23 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 157 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoalbuminemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 157 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 155 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypocalcemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypernatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 159 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 156 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 156 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypoglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | GGT increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 139 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 157 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 15 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 159 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypercalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypokalemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Blood bilirubin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 153 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypomagnesemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 134 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 142 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 15 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 136 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Chronic kidney disease: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyponatremia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 8 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 14 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 138 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 147 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade | 17 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypermagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 154 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | CPK increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hypophosphatemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperglycemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Creatinine increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 155 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 154 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hyperkalemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 6 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Creatinine increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 5 Participants |
Secondary
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Coagulation laboratory test included: activated partial thromboplastin time prolonged, and INR increased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 0= no abnormality; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for coagulation were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Time frame: Day 1 up to maximum of 3 years
Population: SA set included all participants who received at least one dose of study drug. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specific rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Missing (baseline grade) to Grade 0 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 0 (CTCAE grade) | 8 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 1 (CTCAE grade) | 5 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 1 (baseline grade) to Grade 0 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 1 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 2 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Missing (baseline grade) to Grade 0 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 0 (CTCAE grade) | 4 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 1 (CTCAE grade) | 6 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 3 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 3 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 3 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Missing (baseline grade) to Grade 0 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 0 (CTCAE grade) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 0 (CTCAE grade) | 5 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 1 (CTCAE grade) | 7 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 1 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 1 (baseline grade) to Grade 0 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 1 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 1 (baseline grade) to Grade 1 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 0 (baseline grade) to Grade 2 (CTCAE grade) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Activated partial thromboplastin time prolonged: Grade 2 (baseline grade) to Grade 1 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Grade 3 (baseline grade) to Grade 1 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | INR increased: Missing (baseline grade) to Grade 0 (CTCAE grade) | 0 Participants |
Secondary
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of \<=450 to \>500 msec (post-baseline) were summarized. Number of participants with shift from baseline for QTc were assessed. Only those QTc parameters in which at least 1 participant had data were reported.
Time frame: Day 1 up to maximum of 3 years
Population: SA set included all participants who received at least one dose of study drug. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to <=450 msec (post-baseline) | 48 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >450-<=480 msec (post-baseline) | 53 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >480-<=500 msec (post-baseline) | 6 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >500 msec (post-baseline) | 7 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to <=450 msec (post-baseline) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >450-<=480 msec (post-baseline) | 20 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >480-<=500 msec (post-baseline) | 13 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >500 msec (post-baseline) | 5 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >450-<=480 msec (post-baseline) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >480-<=500 msec (post-baseline) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >500 msec (post-baseline) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to <=450 msec (post-baseline) | 100 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >450-<=480 msec (post-baseline) | 39 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >480-<=500 msec (post-baseline) | 7 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450 - <=480 (baseline) to <=450msec (post-baseline) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450 - <=480 msec (baseline) to >450 - <=480msec(post baseline) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450 - <=480 msec (baseline) to >480 - <=500 msec (post baseline) | 5 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >480 msec (baseline) to <=500 msec (post baseline) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450 - <=480 (baseline) to >500 msec (post baseline) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >480 - <=500msec (baseline) to >480 - <=500 msec (post baseline) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >480 msec (baseline) to <=500 msec (post baseline) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to <=450 msec (post-baseline) | 58 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >500 msec (post-baseline) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >450-<=480 msec (post-baseline) | 43 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450 - <=480 msec (baseline) to >450 - <=480msec(post baseline) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >480-<=500 msec (post-baseline) | 11 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to <=450 msec (post-baseline) | 104 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: <=450 msec (baseline) to >500 msec (post-baseline) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >480 - <=500msec (baseline) to >480 - <=500 msec (post baseline) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to <=450 msec (post-baseline) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >450-<=480 msec (post-baseline) | 36 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >450-<=480 msec (post-baseline) | 22 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450 - <=480 msec (baseline) to >480 - <=500 msec (post baseline) | 8 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >480-<=500 msec (post-baseline) | 8 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: <=450 msec (baseline) to >480-<=500 msec (post-baseline) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >450-<=480 msec (baseline) to >500 msec (post-baseline) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450 - <=480 (baseline) to >500 msec (post baseline) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >450-<=480 msec (post-baseline) | 2 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcF: >450 - <=480 (baseline) to <=450msec (post-baseline) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval | QTcB: >480-<=500 msec (baseline) to >480-<=500 msec (post-baseline) | 1 Participants |
Secondary
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Hematology laboratory test included: anemia, hemoglobin increased, INR increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell decreased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for hematology laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Time frame: Day 1 up to maximum of 3 years
Population: SA set included all participants who received at least one dose of study drug. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 5 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 4 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 13 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 29 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 48 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 96 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 29 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 92 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 51 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 21 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 70 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 55 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 2 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 160 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 83 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 7 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 97 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 3 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 43 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 147 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 7 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 45 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 48 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 157 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 41 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 87 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Anemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 31 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 159 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Hemoglobin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 89 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 54 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 13 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 3 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Lymphocyte count increased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 22 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 40 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 97 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 28 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 64 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | Platelet count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade) | 68 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Missing (baseline grade) to Grade <=2 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade) | 0 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade) | 48 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade) | 62 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 | White blood cell decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade) | 1 Participants |
Secondary
Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03
A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. NCI CTCAE v4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.
Time frame: Day 1 up to maximum of 3 years
Population: SA set included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Treatment related AEs | 133 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Treatment related SAEs | 45 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Grade 3 or 4 AE | 97 Participants |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Grade 5 AE | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Grade 5 AE | 4 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Treatment related AEs | 123 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Grade 3 or 4 AE | 72 Participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 | Treatment related SAEs | 37 Participants |
Secondary
Non-intensive Study: Participants Global Impression of Change (PGIC)
PGIC: a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 7-point Likert scale anchored by (1) 'very much improved' to (7) 'very much worse', with (4) =' no change'. The PGIC is a measure of participant rating of global improvement and satisfaction with treatment.
Time frame: Day 1 up to maximum of 3 years
Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, PGIC was not collected, analyzed and reported.
Secondary
Non-intensive Study: Participants Global Impression of Symptoms (PGIS)
PGIS: is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time. It uses a 4-point Likert scale as follows: In the last 24 hours, symptoms are: 1-absent (no symptoms), 2-mild, 3- moderate, 4=severe.
Time frame: Day 1 up to maximum of 3 years
Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, PGIS was not collected, analyzed and reported.
Secondary
Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12
MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). Fatigue was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = not present and 10 = as bad as you can imagine. Percentage of participants who had improvement in fatigue symptoms reported in this outcome measure.
Time frame: Post-baseline up to Week 12
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12 | 11.66 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12 | 15.43 Percentage of participants |
p-value: 0.8359Mantel Haenszel
Secondary
Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg)
CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC.
Time frame: Day 1 up to maximum of 3 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg) | 19.6 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg) | 13.0 Percentage of participants |
Secondary
Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)
CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \<1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutrophil \<0.5\*10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods.
Time frame: Day 1 up to maximum of 3 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | 2.5 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | 4.9 Percentage of participants |
Secondary
Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)
CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC.
Time frame: Day 1 up to maximum of 3 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | 1.8 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | 0.6 Percentage of participants |
Secondary
Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)
CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods.
Time frame: Day 1 up to maximum of 3 years
Population: FA set included all randomized participants. This outcome measure was planned to be analyzed only in non-intensive study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) | 3.1 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) | 3.1 Percentage of participants |
Secondary
Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)
MLFS was defined based on 2017 ELN recommendations. MLFS: MRD (positive or unknown), bone marrow blasts \<5%, no hematologic recovery required, marrow should not be aplastic, at least 200 cells enumerated or cellularity absence of extramedullary disease \>=10%, and absence of blasts with Auer rods.
Time frame: Day 1 up to maximum of 3 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | 3.1 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | 0.6 Percentage of participants |
Secondary
Non-intensive Study: Percentage of Participants With Partial Remission (PR)
PR was defined based on 2017 ELN recommendations. PR: MRD (positive or unknown); bone marrow blasts - decrease to 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%; neutrophil count \>=1.0\*10\^9/L; and platelets count \>=100\*10\^9/L.
Time frame: Day 1 up to maximum of 3 years
Population: FA set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Partial Remission (PR) | 2.5 Percentage of participants |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Percentage of Participants With Partial Remission (PR) | 4.9 Percentage of participants |
Secondary
Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib
Ctrough of Glasdegib was measured in ng/mL.
Time frame: Pre-dose: Cycle 1 Day 15 and Cycle 2 Day 1
Population: Analysis population included all participants who were treated and who had at least 1 value of analyte concentration of Glasdegib available. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specific time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Cycle 1 Day 15 | 565.44 ng/ml | Geometric Coefficient of Variation 126 |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Cycle 2 Day 1 | 472.42 ng/ml | Geometric Coefficient of Variation 122 |
Secondary
Non-intensive Study: Time to Response
TTRi:Participants who achieved CRi or better, as the time from date of randomization to first documentation of response(CRi or better).TTRh:Participants who achieved CRh or better, as the time from date of randomization to first documentation of response(CRh or better). CRi:not qualifying for CR, neutrophil\<0.5\*10\^9/L or platelets\<50\*10\^9, absence of extramedullary disease,absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods.
Time frame: From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years)
Population: FA set included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Time to Response | TTRi | 4.057 Months | Standard Deviation 1.9532 |
| Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Non-intensive Study: Time to Response | TTRh | 4.334 Months | Standard Deviation 1.8853 |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Time to Response | TTRi | 4.093 Months | Standard Deviation 2.1809 |
| Intensive Study: Placebo + Cytarabine + Daunorubicin | Non-intensive Study: Time to Response | TTRh | 4.146 Months | Standard Deviation 2.154 |