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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002822-19 | EudraCT Number | ||
| BRIGHT | Other Identifier | Alias Study Number | |
| BRIGHT AML1019 | Other Identifier | Alias Study Number |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Intensive Study) | Experimental | Glasdegib + '7+3' Induction(s) |
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| Arm B (Intensive Study) | Placebo Comparator | Placebo + '7+3' Induction(s) |
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| Arm A (Non-intensive study) | Experimental | Glasdegib + azacitidine |
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| Arm B (Non-intensive study) | Placebo Comparator | Placebo + azacitidine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glasdegib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 25 months |
| 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. | Baseline up to 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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):
Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with:
18 years of age (In Japan, 20 years of age).
Adequate Organ Function as defined by the following:
QTc interval 470 msec using the Fridericia correction (QTcF).
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.
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.
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.
Female subjects of non childbearing potential must meet at least 1 of the following criteria:
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
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:
Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).
AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality.
Subjects with known active CNS leukemia.
Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.
Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.
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.
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.
Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.
Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.
Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.
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.
Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.
Concurrent administration of herbal preparations.
Major surgery or radiation within 4 weeks of starting study treatment.
Documented or suspected hypersensitivity to any one of the following:
Known active drug or alcohol abuse.
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.
Pregnant females or breastfeeding female subjects.
Known recent or active suicidal ideation or behavior.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Department of Medicine | Los Angeles | California | 90095 | United States | ||
| UCLA Drug Information/Investigational Drugs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37604981 | Derived | Sekeres MA, Montesinos P, Novak J, Wang J, Jeyakumar D, Tomlinson B, Mayer J, Jou E, Robak T, Taussig DC, Dombret H, Merchant A, Shaik N, O'Brien T, Roh W, Liu X, Ma W, DiRienzo CG, Chan G, Cortes JE. Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial. Leukemia. 2023 Oct;37(10):2017-2026. doi: 10.1038/s41375-023-02001-z. Epub 2023 Aug 21. | |
| 31516032 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 milligram per square meter (mg/m^2) daily by intravenous (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 less than (<) 5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram per square meter (gm/m^2) IV for adults greater than or equals to (>=) 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 hematopoietic stem cell transplantation (HSCT) per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 milligram (mg) tablet orally (PO) once daily (QD) from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive complete remission (CR) minimal residual disease (MRD)-negative central laboratory results, whichever came first (1.6 year). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2019 | Jun 2, 2021 |
Randomized, double-blind, multi-center, placebo controlled study.
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Double blind study.
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| daunorubicin + cytarabine | Drug | '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'); |
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| azacitidine | Drug | 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. |
|
| Placebo | Drug | 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. |
|
| Placebo | Drug | Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first. |
|
| glasdegib | Drug | Glasdegib 100 mg PO QD is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue glasdegib until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first. |
|
| cytarabine | Drug | 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. |
|
| HSCT | Procedure | If required, and done per standard of care post Induction(s). |
|
| Post-baseline up to Week 8 |
| 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. | Post-baseline up to Week 12 |
| 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). | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | 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) |
| 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. | 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) |
| 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. | From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years) |
| 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. | 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) |
| 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. | 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) |
| 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". | Day 1 up to maximum of 2 years |
| 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". | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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). | Day 1 up to maximum of 2 years |
| 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). | Day 1 up to maximum of 3 years |
| 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". | Day 1 up to maximum of 2 years |
| 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". | Day 1 up to maximum of 3 years |
| 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". | Day 1 up to maximum of 2 years |
| 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". | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Ctrough of Glasdegib was measured in nanogram per milliliter (ng/mL). | Induction, Day 10+/-1: pre-dose, 1, 4 hour (hr); Consolidation phase, Day 1: pre-dose, 1, 4 hr |
| Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Ctrough of Glasdegib was measured in ng/mL. | Pre-dose: Cycle 1 Day 15 and Cycle 2 Day 1 |
| 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. | Day 1 up to maximum of 2 years |
| 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. | Day 1 up to maximum of 3 years |
| Los Angeles |
| California |
| 90095 |
| United States |
| UCLA Hematology/Oncology Clinic | Los Angeles | California | 90095 | United States |
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | United States |
| UC Irvine Health - Chao Family Comprehensive Cancer Center | Orange | California | 92868-3201 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| UCLA Hematology/Oncology - Westlake Village | Westlake Village | California | 91361 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | United States |
| Tufts Medical Center Investigational Drug Pharmacy | Boston | Massachusetts | 02111 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| MidAmerica Division, Inc., c/o Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Northwell Health/Monter Cancer Center | Lake Success | New York | 11042 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| TriStar Bone Marrow Transplant | Nashville | Tennessee | 37203 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Blood Cancer and Stem Cell Transplant Clinic | San Antonio | Texas | 78229 | United States |
| Methodist Healthcare System of San Antonio | San Antonio | Texas | 78229 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU | Salzburg | 5020 | Austria |
| Uniklinikum Salzburg, Landeskrankenhaus Salzburg | Salzburg | 5020 | Austria |
| Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel | Vienna | 1130 | Austria |
| AZ Sint-Jan Brugge-Oostende av | Bruges | B-8000 | Belgium |
| Universitaire Ziekenhuizen Brussel (UZ Brussel) | Brussels | B-1090 | Belgium |
| Universitaire Ziekenhuizen Brussel | Brussels | B-1090 | Belgium |
| Universitaire Ziekenhuizen Leuven | Leuven | B-3000 | Belgium |
| Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Sunnybrook Research Institute | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| The First Affiliated Hospital of USTC, Anhui Provincial Hospital | Hefei | Anhui | 230001 | China |
| Anhui Provincial Hospital | Hefei | Anhui | 230071 | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
| Guangdong Second Provincial General Hospital | Guangzhou | Guangdong | 510317 | China |
| Hebei Yanda Lu Daopei Hospital | Langfang | Hebei | 065201 | China |
| Henan Provincial People's Hospital/Hematology Department | Zhengzhou | Henan | 450003 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center | Wuhan | Hubei | 430030 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300020 | China |
| The First Affiliated Hospital College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | 200025 | China |
| Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Nemocnicni lekarna | Brno | 625 00 | Czechia |
| Ustavni lekarna | Ostrava - Poruba | 708 52 | Czechia |
| Klinika hematoonkologie | Ostrava-Poruba | 708 52 | Czechia |
| Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady | Prague | 100 34 | Czechia |
| Ústavni lékárna | Prague | 100 34 | Czechia |
| CHU Henri Mondor | Créteil | 94010 | France |
| CHU de Nantes Hotel Dieu | Nantes | 44093 | France |
| CHU de Nantes | Nantes | 44093 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Centre Hospitalier Lyon Sud - Service d'Hematologie | Pierre-Bénite | 69495 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Klinikum der Universitaet Muenchen | Munich | Bavaria | 81377 | Germany |
| Philipps-Universitaet Marburg | Marburg | Hesse | 35032 | Germany |
| Universitätsklinikum Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitaetsklinikum Muenster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek | Debrecen | 4032 | Hungary |
| Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika | Debrecen | 4032 | Hungary |
| Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály | Győr | 9024 | Hungary |
| Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvár | 7400 | Hungary |
| Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia | Nyíregyháza | 4400 | Hungary |
| Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, | Nyíregyháza | 4400 | Hungary |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center (Ein Kerem) | Jerusalem | 91120 | Israel |
| Hemato-oncology ambulatory Service | Petah Tikva | 4941492 | Israel |
| Rabin Medical Center, Beilinson Hospital | Petah Tikva | 4941492 | Israel |
| AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia | Torrette Di Ancona | Ancona | 60126 | Italy |
| SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi | Torette Di Ancona | AN | 60126 | Italy |
| A.O.U. di Ferrara- Arcispedale Sant'Anna, | Cona, Ferrara | FE | 44124 | Italy |
| AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro - | Pesaro | PU | 61122 | Italy |
| Azienda Ospedaliera Universitaria Senese. | Siena | SI | 53100 | Italy |
| Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
| Japanese Red Cross Nagoya Daini Hospital | Nagoya | Aichi-ken | 466-8650 | Japan |
| University of Fukui Hospital | Yoshida-gun | Fukui | 910-1193 | Japan |
| Gunma University Hospital | Maebashi | Gunma | 371-8511 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Yokohama City University Medical Center | Yokohama | Kanagawa | 232-0024 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Osaka City University Hospital | Osaka | Osaka | 545-8586 | Japan |
| Kindai University Hospital | Ōsaka-sayama | Osaka | 589-8511 | Japan |
| Shizuoka Cancer Center | Sunto-gun | Shizuoka | 411-8777 | Japan |
| National Hospital Organization Disaster Medical Center | Tachikawa | Tokyo | 190-0014 | Japan |
| Akita University Hospital | Akita | 010-8543 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| National Hospital Organization Kumamoto Medical Center | Kumamoto | 860-0008 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Instituto Nacional de Cancerología | México | MÉX | 14080 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 64460 | Mexico |
| Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| WWCOiT im. M. Kopernika w Lodzi | Lodz | 93-513 | Poland |
| Institutul Oncologic 'Prof. Dr. Ion Chiricuta' | Cluj-Napoca | Cluj | 400124 | Romania |
| Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie | Craiova | Dolj | 200136 | Romania |
| Sp. Clinic de Urgenta Militar Central Dr. Carol Davila | Bucharest | 010825 | Romania |
| Spitalul Clinic Coltea, Clinica de Hematologie | Bucharest | 030171 | Romania |
| State Budgetary Healthcare Institution of Moscow | Moscow | 129301 | Russia |
| SBHI NNR NN RCH n. a. N.A. Semashko | Nizhny Novgorod | 603126 | Russia |
| State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH) | Ryazan | 390039 | Russia |
| V.A Almazov NMRC | Saint Petersburg | 197341 | Russia |
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Clinical Trial Center, Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Universitetssjukhuset Orebro | Örebro | 701 85 | Sweden |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | 141 86 | Sweden |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Chang Gung Memorial Hospital-Linkou Branch | Taoyuan City | 333 | Taiwan |
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | WEST Midlands | B15 2TH | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| Derived |
| Cortes JE, Dombret H, Merchant A, Tauchi T, DiRienzo CG, Sleight B, Zhang X, Leip EP, Shaik N, Bell T, Chan G, Sekeres MA. Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials. Future Oncol. 2019 Nov;15(31):3531-3545. doi: 10.2217/fon-2019-0373. Epub 2019 Sep 13. |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis (FA) set included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | FA set included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline up to 25 months |
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| 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. | FA set included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline up to 25 months |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Post-baseline up to Week 8 |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Post-baseline up to Week 12 |
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| 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). | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 2 years |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 3 years |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 2 years |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 3 years |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 2 years |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 3 years |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 2 years |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 3 years |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 2 years |
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| 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. | FA set included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 3 years |
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| 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. | FA set included all randomized participants. This outcome measure was planned to be analyzed only in non-intensive study. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 up to maximum of 3 years |
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| 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. | 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. | Posted | 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) |
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| 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. | 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. | Posted | 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) |
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| 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. | FA set included all randomized participants. | Posted | Mean | Standard Deviation | Months | From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years) |
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| 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. | 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. | Posted | 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) |
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| 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. | 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. | Posted | 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) |
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| 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". | 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. | Posted | Day 1 up to maximum of 2 years |
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| 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". | 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. | Posted | Day 1 up to maximum of 3 years |
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| 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. | 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. | Posted | Day 1 up to maximum of 2 years |
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| 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. | 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. | Posted | Day 1 up to maximum of 3 years |
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| 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). | 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. | Posted | Day 1 up to maximum of 2 years |
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| 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). | 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. | Posted | Day 1 up to maximum of 3 years |
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| 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". | 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. | Posted | Day 1 up to maximum of 2 years |
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| 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". | 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. | Posted | Day 1 up to maximum of 3 years |
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| 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". | 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. | Posted | Day 1 up to maximum of 2 years |
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| 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". | 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. | Posted | Day 1 up to maximum of 3 years |
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| 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. | Safety Analysis (SA) set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to maximum of 2 years |
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| 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. | SA set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to maximum of 3 years |
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| 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. | SA set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to maximum of 2 years |
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| 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. | SA set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to maximum of 3 years |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 up to maximum of 2 years |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 up to maximum of 3 years |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 up to maximum of 2 years |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 up to maximum of 3 years |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 up to maximum of 2 years |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 up to maximum of 3 years |
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| Secondary | Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Ctrough of Glasdegib was measured in nanogram per milliliter (ng/mL). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | Induction, Day 10+/-1: pre-dose, 1, 4 hour (hr); Consolidation phase, Day 1: pre-dose, 1, 4 hr |
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| Secondary | Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib | Ctrough of Glasdegib was measured in ng/mL. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | Pre-dose: Cycle 1 Day 15 and Cycle 2 Day 1 |
|
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 up to maximum of 2 years |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 up to maximum of 3 years |
|
Intensive study: Day 1 up to maximum of 2 years; non-intensive study: Day 1 up to maximum of 3 years
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-Cause Mortality was assessed for all randomized participants whereas serious and other adverse events were assessed for safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 90 | 201 | 86 | 198 | 194 | 198 |
| EG001 | 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). | 88 | 203 | 92 | 201 | 195 | 201 |
| EG002 | 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). | 117 | 163 | 117 | 162 | 154 | 162 |
| EG003 | 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). | 113 | 162 | 124 | 160 | 148 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Enterobacter bacteraemia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Splenic necrosis | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intracardiac mass | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Graft versus host disease in skin | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anorectal infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Candida pneumonia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Clostridial sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Clostridium bacteraemia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Disseminated varicella zoster virus infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Soft tissue inflammation | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Herpes dermatitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Subdiaphragmatic abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Systemic infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Systemic mycosis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Electroencephalogram abnormal | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Differentiation syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrointestinal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neoplasm prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Aneurysm ruptured | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardiorenal syndrome | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
|
In this study, inadvertently a participant was counted twice for an non-SAE "Pyrexia" at PCD, at SCD update this duplicity has been rectified. Due to this reason total number of participants affected by non-SAE in non-intensive placebo arm was updated to "148".
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2020 | Jun 2, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592580 | glasdegib |
| D003630 | Daunorubicin |
| D003561 | Cytarabine |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D001372 | Aza Compounds |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| OG001 | 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). |
|
|
|
| OG001 | 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). |
|
|
|
| OG001 | 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). |
|
|
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| 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). |
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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).
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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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). |
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| OG001 | 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). |
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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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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