Entospletinib Monotherapy and in Combination With Chemoth... | NCT02343939 | Trialant
NCT02343939
Sponsor
Gilead Sciences
Status
Terminated
Last Update Posted
Nov 15, 2019Actual
Enrollment
148Actual
Phase
Phase 1Phase 2
Conditions
Acute Myeloid Leukemia
Interventions
Entospletinib
Daunorubicin
Cytarabine
Decitabine
Azacitidine
Countries
United States
Canada
Germany
Protocol Section
Identification Module
NCT ID
NCT02343939
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-339-1559
Secondary IDs
ID
Type
Description
Link
2016-003353-16
EudraCT Number
Brief Title
Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)
Official Title
A Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia (AML)
Acronym
ENTO in AML
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Nov 2019
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 1, 2015Actual
Primary Completion Date
Sep 4, 2018Actual
Completion Date
Feb 21, 2019Actual
First Submitted Date
Jan 16, 2015
First Submission Date that Met QC Criteria
Jan 16, 2015
First Posted Date
Jan 22, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 1, 2019
Results First Submitted that Met QC Criteria
Nov 13, 2019
Results First Posted Date
Nov 15, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 13, 2019
Last Update Posted Date
Nov 15, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the efficacy, safety, and tolerability of entospletinib when administered as monotherapy or in combination with chemotherapy in adults with acute myeloid leukemia (AML).
Detailed Description
Not provided
Conditions Module
Conditions
Acute Myeloid Leukemia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
148Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Entospletinib + daunorubicin + cytarabine (Group A)
Experimental
Dose Escalation: Entospletinib up to 400 mg for 14 days and then entospletinib up to 400 mg in combination with daunorubicin and cytarabine for up to two 14-day cycles.
Dose Expansion: Entospletinib 400 mg for 14 days and then entospletinib 400 mg in combination with daunorubicin and cytarabine for up to two 14-day cycles. Some participants will have the option to receive post-induction therapy with entospletinib 400 mg in combination with cytarabine/cytosine arabinoside (ARA-C). Participants may receive maintenance therapy with 28-day cycles of entospletinib 400 mg for up to twelve 28-day cycles, if the participant is not eligible for stem cell transplant.
Drug: Entospletinib
Drug: Daunorubicin
Drug: Cytarabine
Entospletinib + decitabine (Group B)
Experimental
Dose Escalation: Entospletinib 400 mg for 14 days and then entospletinib 400 mg in combination with decitabine for 10 days beginning on Day 1 of every 28-day cycle (at least 2 cycles of induction therapy but no more than 4 cycles). Participants who are intolerant of decitabine may switch to entospletinib monotherapy maintenance at any time after completing the first 2 cycles.
Dose Expansion: Entospletinib 400 mg for 14 days for the safety run-in participants or Entospletinib 400 mg for 5 days for the randomization participants. Then entospletinib 400 mg in combination with decitabine or azacitidine (at least 2 cycles of induction therapy but no more than 4 cycles). Some participants will have the option to receive maintenance therapy with entospletinib in combination with decitabine or azacitidine. Participants who are intolerant of decitabine or azacitidine may switch to entospletinib monotherapy maintenance at any time after completing the first 2 cycles.
Drug: Entospletinib
Drug: Decitabine
Drug: Azacitidine
Entospletinib (Group C)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Entospletinib
Drug
Tablet(s) administered orally every 12 hours
Entospletinib (Group C)
Entospletinib + daunorubicin + cytarabine (Group A)
Entospletinib + decitabine (Group B)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment. DLT assessment was applicable only for Phase 1b and Phase 2 safety run-in participants.
Group A: Cycle 0 Day 1 to Cycle 2 Day 28; Group B: Cycle 0 Day 1 to Cycle 1 Day 28; Group C: Cycle 1 Day 1 to Cycle 1 Day 28 (Cycle length: for Cycle 0 = 14 days, for all other cycles = 28 days)
Percentage of Participants With Morphologic Complete Remission (CR) at the End of Induction
Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Morphologic CR included CR and cytogenetic CR (CRc). CR required all of the following: < 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/microliter (mcL); Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis.
At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)
Percentage of Participants With Composite Complete Remission at the End of Induction
Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Composite complete remission included CR, CRc, and morphologic complete remission with incomplete blood count recovery (CRi). CR required all of the following: < 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR criteria except the criterion of neutrophils and platelets.
At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)
Secondary Outcomes
Measure
Description
Time Frame
Duration of Exposure of Entospletinib
First dose date up to approximately 3 years
Event Free Survival (EFS)
EFS was defined as the time interval from the start of the study therapy until the date of treatment failure, acute myeloid leukemia (AML) relapse, or death from any cause, whichever occurred first. Participants who received other anti-cancer therapy (prior to the event if any) were censored. Median EFS was analyzed using Kaplan-Meier (KM) method.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Adults with AML in need of treatment
Group A : Individuals ≥ 18 years of age with previously untreated AML by World Health Organization (WHO) criteria who are able and should receive up to 2 cycles of induction chemotherapy with 7+3 as determined by the treating physician
Group B: Individuals > 70 years of age with previously untreated AML by WHO criteria; or individuals ≤ 70 years of age with previously untreated AML who refuse or are unable to receive chemotherapy with 7+3 as determined by the treating physician
Group C: Individuals ≥ 18 years of age with relapsed/refractory AML by WHO criteria; or with relapsed/refractory AML with mixed-lineage leukemia (MLL); or with previously untreated AML by WHO criteria and who would have met disease eligibility criteria for Group A or B but refuse or are unable to receive chemotherapy and hypomethylating agent as determined by the treating physician
Key Exclusion Criteria:
Known active central nervous system or leptomeningeal lymphoma
Subjects with acute promyelocytic leukemia (M3)
Treatment with proton pump inhibitors (PPIs) within 7 days prior to enrollment.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Gilead Study Director
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UCLA
Los Angeles
California
United States
University of Chicago
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
233 participants were screened.
Recruitment Details
Participants were enrolled at study sites in United States, Canada, and Germany. The first participant was screened on 01 July 2015.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 15, 2018
Sep 5, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Dose Escalation: Entospletinib up to 800 mg for 28-day cycles until the participant meets criteria for study treatment discontinuation per the study protocol.
Dose Expansion: Entospletinib 400 mg for 28-day cycles until the participant meets criteria for study treatment discontinuation per the protocol.
Drug: Entospletinib
GS-9973
ENTO
Daunorubicin
Drug
60 mg/m^2 administered intravenously daily on Days 1 to 3 for up to two 14-day induction cycles
Entospletinib + daunorubicin + cytarabine (Group A)
Cytarabine
Drug
100 mg/m^2 administered intravenously daily on Days 1 to 7 for up to two 14-day cycles
Entospletinib + daunorubicin + cytarabine (Group A)
Decitabine
Drug
20 mg/m^2 administered intravenously
Entospletinib + decitabine (Group B)
Azacitidine
Drug
75 mg/m^2 administered intravenously or subcutaneously
Entospletinib + decitabine (Group B)
Percentage of Participants With Overall Response at the End of Induction
Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Overall response included CR, CRc, CRi, and partial remission (PR). CR required all of the following: < 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR criteria except the criterion of neutrophils and platelets. PR required all of the following: ≥ 50% decrease in blasts in bone marrow aspirate to a range of 5% to 25%; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; Independent of transfusions; and A value of ≤ 5% blasts was also considered a PR if Auer rods were detected.
At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)
First dose date up to approximately 38 months
Overall Survival (OS)
OS was defined as the time interval from the start of the study therapy to death from any cause. Median OS was analyzed using KM method.
First dose date up to approximately 38 months
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
First dose date up to the last dose date plus 30 days (maximum: 18 months)
Percentage of Participants Who Experienced Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
First dose date up to the last dose date plus 30 days (maximum: 18 months)
Chicago
Illinois
United States
Loyola University Medical Center
Maywood
Illinois
United States
Indiana University
Indianapolis
Indiana
United States
University of Kansas Medical Center Research Institute, Inc
Fairway
Kansas
United States
Dana Farber Cancer Institute
Boston
Massachusetts
United States
Henry Ford Health System
Detroit
Michigan
United States
Karmanos Cancer Institute
Detroit
Michigan
United States
Weill Cornell Medical College - New York - Presbyterian Hospital
New York
New York
United States
Duke Cancer Center
Durham
North Carolina
United States
University Hospitals Case Medical Center
Cleveland
Ohio
United States
Ohio State University
Columbus
Ohio
United States
Oregon Health & Science University
Portland
Oregon
97239
United States
Saint Francis Cancer Center
Greenville
South Carolina
United States
Princess Margaret
Toronto
Ontario
Canada
Jewish General Hospital
Montreal
Quebec
Canada
Universitätsklinikum Frankfurt Medizinische Klinik II
Frankfurt
60590
Germany
FG001
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
FG002
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
FG003
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
FG004
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
FG005
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
FG006
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
FG007
Group C Phase 1b/2 ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
FG008
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
FG0003 subjects
FG00150 subjects
FG0025 subjects
FG0036 subjects
FG0048 subjects
FG00517 subjects
FG00615 subjects
FG00737 subjects
FG0087 subjects
COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0003 subjects
FG00148 subjects
FG0025 subjects
FG0036 subjects
FG0048 subjects
FG00517 subjects
FG00615 subjects
FG00737 subjects
FG0087 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG00115 subjects
FG0024 subjects
FG0032 subjects
FG0045 subjects
FG00511 subjects
FG0068 subjects
FG00722 subjects
FG0081 subjects
Study terminated by sponsor
FG0000 subjects
FG00127 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrew consent
FG0003 subjects
FG0016 subjects
FG0021 subjects
FG0032 subjects
FG004
Treatment failure
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Investigator's discretion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Never Treated With ENTO
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Full Analysis Set included all participants who received at least 1 dose of study drug with treatment designated according to the planned treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
BG001
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
BG002
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
BG003
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
BG004
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
BG005
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
BG006
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
BG007
Group C Phase 1b/2 ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
BG008
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG00150
BG0025
BG0036
BG0048
BG00517
BG00614
BG00735
BG0087
BG009145
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
< 65 Years
BG0003
BG00132
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG00121
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Ethnicity
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
White/Caucasian
BG0003
BG00144
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
Title
Measurements
BG0000
BG0014
BG002
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
Primary
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment. DLT assessment was applicable only for Phase 1b and Phase 2 safety run-in participants.
The DLT Analysis Set included all participants who received 21 days of ENTO (applicable to all groups) and all doses of cytarabine and daunorubicin in Group A Phase 1b, decitabine in Group B Phase 1b, or azacitidine in Group B Phase 2 safety run-in during the DLT assessment window; or experienced a DLT during the DLT assessment window.
Posted
Number
percentage of participants
Group A: Cycle 0 Day 1 to Cycle 2 Day 28; Group B: Cycle 0 Day 1 to Cycle 1 Day 28; Group C: Cycle 1 Day 1 to Cycle 1 Day 28 (Cycle length: for Cycle 0 = 14 days, for all other cycles = 28 days)
ID
Title
Description
OG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG001
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
OG002
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
OG003
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG004
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG005
Group C Phase 1b/2 ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG006
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Percentage of Participants With Morphologic Complete Remission (CR) at the End of Induction
Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Morphologic CR included CR and cytogenetic CR (CRc). CR required all of the following: < 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/microliter (mcL); Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis.
The Full Analysis Set included all participants who received at least 1 dose of study drug with treatment designated according to the planned treatment.
Posted
Number
95% Confidence Interval
percentage of participants
At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)
ID
Title
Description
OG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG001
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin
Primary
Percentage of Participants With Composite Complete Remission at the End of Induction
Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Composite complete remission included CR, CRc, and morphologic complete remission with incomplete blood count recovery (CRi). CR required all of the following: < 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR criteria except the criterion of neutrophils and platelets.
Participants in the Full Analysis Set were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)
ID
Title
Description
OG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG001
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin
Primary
Percentage of Participants With Overall Response at the End of Induction
Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Overall response included CR, CRc, CRi, and partial remission (PR). CR required all of the following: < 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR criteria except the criterion of neutrophils and platelets. PR required all of the following: ≥ 50% decrease in blasts in bone marrow aspirate to a range of 5% to 25%; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; Independent of transfusions; and A value of ≤ 5% blasts was also considered a PR if Auer rods were detected.
Participants in the Full Analysis Set were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)
ID
Title
Description
OG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
Secondary
Duration of Exposure of Entospletinib
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Posted
Median
Full Range
weeks
First dose date up to approximately 3 years
ID
Title
Description
OG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG001
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
Secondary
Event Free Survival (EFS)
EFS was defined as the time interval from the start of the study therapy until the date of treatment failure, acute myeloid leukemia (AML) relapse, or death from any cause, whichever occurred first. Participants who received other anti-cancer therapy (prior to the event if any) were censored. Median EFS was analyzed using Kaplan-Meier (KM) method.
Participants in the Full Analysis Set were analyzed.
Posted
Median
95% Confidence Interval
months
First dose date up to approximately 38 months
ID
Title
Description
OG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG001
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
Secondary
Overall Survival (OS)
OS was defined as the time interval from the start of the study therapy to death from any cause. Median OS was analyzed using KM method.
Participants in the Full Analysis Set were analyzed.
Posted
Median
95% Confidence Interval
months
First dose date up to approximately 38 months
ID
Title
Description
OG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG001
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG002
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin
Secondary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Participants in the Safety Analysis Set were analyzed.
Posted
Number
percentage of participants
First dose date up to the last dose date plus 30 days (maximum: 18 months)
ID
Title
Description
OG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG001
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
Secondary
Percentage of Participants Who Experienced Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
Participants in the Safety Analysis Set who had non-missing postbaseline value prior to or on the last dosing date plus 30 days were analyzed.
Posted
Number
percentage of participants
First dose date up to the last dose date plus 30 days (maximum: 18 months)
ID
Title
Description
OG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG001
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
Time Frame
All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
Description
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
2
3
0
3
3
3
EG001
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
21
50
23
50
50
50
EG002
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
5
5
5
5
5
5
EG003
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
4
6
5
6
6
6
EG004
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
5
8
7
8
7
8
EG005
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
12
17
11
17
17
17
EG006
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
11
14
7
14
14
14
EG007
Group C Phase 1b/2 ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
30
35
19
35
33
35
EG008
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
6
7
4
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00113 affected50 at risk
EG0024 affected5 at risk
EG0034 affected6 at risk
EG0043 affected8 at risk
EG0058 affected17 at risk
EG0060 affected14 at risk
EG0075 affected35 at risk
EG0080 affected7 at risk
Angina pectoris
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0021 affected5 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0021 affected5 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Cellulitis staphylococcal
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Device related infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Lung infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0022 affected5 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Otitis media
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0021 affected5 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Transaminases increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Troponin I increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0021 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Acute lymphocytic leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0021 affected5 at risk
EG003
Neuromyopathy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0021 affected5 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0021 affected5 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Lung consolidation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00124 affected50 at risk
EG0023 affected5 at risk
EG0031 affected6 at risk
EG0042 affected8 at risk
EG0055 affected17 at risk
EG0066 affected14 at risk
EG00710 affected35 at risk
EG0083 affected7 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0002 affected3 at risk
EG00136 affected50 at risk
EG0021 affected5 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0017 affected50 at risk
EG0021 affected5 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected50 at risk
EG0020 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0016 affected50 at risk
EG0020 affected5 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0014 affected50 at risk
EG0020 affected5 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Eye oedema
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Eye pain
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0021 affected5 at risk
EG003
Optic nerve cupping
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Scleral hyperaemia
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Vision blurred
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00110 affected50 at risk
EG0020 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0017 affected50 at risk
EG0020 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG00113 affected50 at risk
EG0020 affected5 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0021 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Anal ulcer
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0021 affected5 at risk
EG003
Angina bullosa haemorrhagica
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG00120 affected50 at risk
EG0023 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG00134 affected50 at risk
EG0021 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0021 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0018 affected50 at risk
EG0020 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0016 affected50 at risk
EG0021 affected5 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0021 affected5 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected50 at risk
EG0020 affected5 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Intestinal dilatation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0003 affected3 at risk
EG00134 affected50 at risk
EG0024 affected5 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected50 at risk
EG0020 affected5 at risk
EG003
Pancreatic disorder
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Regurgitation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0018 affected50 at risk
EG0021 affected5 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 affected3 at risk
EG00116 affected50 at risk
EG0020 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Catheter site dermatitis
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Catheter site erythema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Catheter site pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Catheter site rash
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Chest pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Chills
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0018 affected50 at risk
EG0020 affected5 at risk
EG003
Device related thrombosis
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Face oedema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG00114 affected50 at risk
EG0023 affected5 at risk
EG003
Feeling hot
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
General physical health deterioration
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Injection site erythema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Injection site pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Malaise
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00110 affected50 at risk
EG0021 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0017 affected50 at risk
EG0020 affected5 at risk
EG003
Oedema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.1
Systematic Assessment
EG0002 affected3 at risk
EG00129 affected50 at risk
EG0022 affected5 at risk
EG003
Pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Performance status decreased
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0019 affected50 at risk
EG0020 affected5 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected50 at risk
EG0020 affected5 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Candida infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Device related infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0019 affected50 at risk
EG0021 affected5 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Leptotrichia infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Lung infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00111 affected50 at risk
EG0021 affected5 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Mycobacterium avium complex infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected50 at risk
EG0020 affected5 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0021 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected50 at risk
EG0021 affected5 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0021 affected5 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0016 affected50 at risk
EG0020 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0018 affected50 at risk
EG0020 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0018 affected50 at risk
EG0020 affected5 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00112 affected50 at risk
EG0020 affected5 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Blood creatinine decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0016 affected50 at risk
EG0021 affected5 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Body temperature increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Chest X-ray abnormal
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected50 at risk
EG0020 affected5 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected50 at risk
EG0021 affected5 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected50 at risk
EG0021 affected5 at risk
EG003
Lipase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0021 affected5 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00116 affected50 at risk
EG0022 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00126 affected50 at risk
EG0023 affected5 at risk
EG003
Spleen palpable
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Troponin I increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0022 affected5 at risk
EG003
Troponin increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Ultrasound liver abnormal
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected50 at risk
EG0021 affected5 at risk
EG003
Weight increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0002 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00118 affected50 at risk
EG0022 affected5 at risk
EG003
White blood cell count increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0021 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00122 affected50 at risk
EG0022 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0021 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected50 at risk
EG0020 affected5 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00110 affected50 at risk
EG0021 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0017 affected50 at risk
EG0021 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected50 at risk
EG0021 affected5 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0017 affected50 at risk
EG0021 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0016 affected50 at risk
EG0020 affected5 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected50 at risk
EG0020 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0016 affected50 at risk
EG0020 affected5 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Vertebral lesion
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00114 affected50 at risk
EG0020 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00111 affected50 at risk
EG0020 affected5 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG00120 affected50 at risk
EG0022 affected5 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected50 at risk
EG0020 affected5 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Tremor
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0017 affected50 at risk
EG0021 affected5 at risk
EG003
Apathy
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected50 at risk
EG0021 affected5 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected50 at risk
EG0020 affected5 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00116 affected50 at risk
EG0022 affected5 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0018 affected50 at risk
EG0020 affected5 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected50 at risk
EG0022 affected5 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected50 at risk
EG0020 affected5 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00118 affected50 at risk
EG0021 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00120 affected50 at risk
EG0022 affected5 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00110 affected50 at risk
EG0021 affected5 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00111 affected50 at risk
EG0020 affected5 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0017 affected50 at risk
EG0021 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00110 affected50 at risk
EG0020 affected5 at risk
EG003
Paranasal sinus hyposecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected50 at risk
EG0020 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0021 affected5 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0016 affected50 at risk
EG0020 affected5 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0021 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0014 affected50 at risk
EG0020 affected5 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0017 affected50 at risk
EG0020 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected50 at risk
EG0020 affected5 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG00121 affected50 at risk
EG0021 affected5 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected50 at risk
EG0020 affected5 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Embolism
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0021 affected5 at risk
EG003
Haematoma
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected50 at risk
EG0020 affected5 at risk
EG003
Hot flush
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected50 at risk
EG0020 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG00112 affected50 at risk
EG0020 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected3 at risk
EG0017 affected50 at risk
EG0020 affected5 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected50 at risk
EG0020 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG002
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy). Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
OG003
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
OG004
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG005
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG006
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG007
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG008
Group C Phase 1b ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG009
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG010
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG011
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG012
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
Units
Counts
Participants
OG0003
OG0019
OG00241
OG0035
OG0046
OG0058
OG00617
OG00714
OG0087
OG0097
OG0106
OG01113
OG0129
Title
Denominators
Categories
Title
Measurements
OG00066.7(9.4 to 99.2)
OG00166.7(29.9 to 92.5)
OG00246.3(30.7 to 62.6)
OG0030.0(0.0 to 52.2)
OG00416.7(0.4 to 64.1)
OG00525.0(3.2 to 65.1)
OG0060.0(0.0 to 19.5)
OG0077.1(0.2 to 33.9)
OG0080.0(0.0 to 41.0)
OG0090.0(0.0 to 41.0)
OG0100.0(0.0 to 45.9)
OG01115.4(1.9 to 45.4)
OG01211.1(0.3 to 48.2)
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG002
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy). Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
OG003
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
OG004
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG005
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG006
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG007
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG008
Group C Phase 1b ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG009
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG010
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG011
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG012
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
Units
Counts
Participants
OG0003
OG0019
OG00241
OG0035
OG0046
OG0058
OG00617
OG00714
OG0087
OG0097
OG0106
OG01113
OG0129
Title
Denominators
Categories
Title
Measurements
OG000100.0(29.2 to 100)
OG00177.8(40 to 97.2)
OG00265.9(49.4 to 79.9)
OG00340.0(5.3 to 85.3)
OG00450.0(11.8 to 88.2)
OG00525.0(3.2 to 65.1)
OG00623.5(6.8 to 49.9)
OG00714.3(1.8 to 42.8)
OG00814.3(0.4 to 57.9)
OG0090.0(0.0 to 41.0)
OG0100.0(0.0 to 45.9)
OG01115.4(1.9 to 45.4)
OG01211.1(0.3 to 48.2)
OG001
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
OG002
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy). Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
OG003
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
OG004
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG005
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG006
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG007
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG008
Group C Phase 1b ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG009
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG010
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG011
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG012
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
Units
Counts
Participants
OG0003
OG0019
OG00241
OG0035
OG0046
OG0058
OG00617
OG00714
OG0087
OG0097
OG0106
OG01113
OG0129
Title
Denominators
Categories
Title
Measurements
OG000100.0(29.2 to 100)
OG00177.8(40 to 97.2)
OG00270.7(54.5 to 83.9)
OG00340.0(5.3 to 85.3)
OG00450.0(11.8 to 88.2)
OG00525.0(3.2 to 65.1)
OG00623.5(6.8 to 49.9)
OG00714.3(1.8 to 42.8)
OG00814.3(0.4 to 57.9)
OG0090.0(0 to 41)
OG0100.0(0 to 45.9)
OG01115.4(1.9 to 45.4)
OG01211.1(0.3 to 48.2)
OG002
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
OG003
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG004
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG005
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG006
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG007
Group C Phase 1b/2 ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG008
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
Units
Counts
Participants
OG0003
OG00150
OG0025
OG0036
OG0048
OG00517
OG00614
OG00735
OG0087
Title
Denominators
Categories
Title
Measurements
OG0008.6(6.1 to 10.0)
OG0017.1(0.9 to 72.9)
OG00213.7(1.6 to 50.9)
OG00315.4(1.9 to 58.9)
OG00410.1(1.3 to 39.4)
OG00513.9(1.9 to 40.0)
OG00610.1(0.9 to 47.0)
OG0074.4(1.4 to 15.6)
OG0087.6(2.0 to 9.0)
OG002
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy). Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
OG003
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
OG004
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG005
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG006
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG007
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG008
Group C Phase 1b ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG009
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG010
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG011
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG012
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
Units
Counts
Participants
OG0003
OG0019
OG00241
OG0035
OG0046
OG0058
OG00617
OG00714
OG0087
OG0097
OG0106
OG01113
OG0129
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and confidence interval limits could not be calculated due to low number of participants with an event.
OG0011.9(0.9 to 1.9)
OG0029.0(2.3 to NA)Upper limit of confidence interval could not be calculated due to low number of participants with an event.
OG0032.2(0.5 to 4.7)
OG0042.9(1.1 to 7.7)
OG0052.3(0.5 to 9.0)
OG0063.2(0.5 to 4.2)
OG0072.4(2.1 to 3.9)
OG0081.8(0.9 to 1.9)
OG0091.8(0.5 to 1.9)
OG0101.0(0.7 to 2.8)
OG0111.0(0.8 to 2.7)
OG0121.7(0.8 to 1.9)
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m^2 on Days 1-7 and daunorubicin 60 mg/m^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy). Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
OG003
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
OG004
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG005
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG006
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG007
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG008
Group C Phase 1b ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG009
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG010
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG011
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG012
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
Units
Counts
Participants
OG0003
OG0019
OG00241
OG0035
OG0046
OG0058
OG00617
OG00714
OG0087
OG0097
OG0106
OG01113
OG0129
Title
Denominators
Categories
Title
Measurements
OG00037.1(9.1 to NA)Upper limit of confidence interval could not be calculated due to low number of participants with an event.
OG00134.1(1.2 to NA)Upper limit of confidence interval could not be calculated due to low number of participants with an event.
OG002NA(16.8 to NA)Median and upper limit of confidence interval could not be calculated due to low number of participants with an event.
OG0033.2(0.8 to 12.7)
OG0045.3(2.4 to NA)Upper limit of confidence interval could not be calculated due to low number of participants with an event.
OG0056.9(1.4 to NA)Upper limit of confidence interval could not be calculated due to low number of participants with an event.
OG0067.3(2.4 to NA)Upper limit of confidence interval could not be calculated due to low number of participants with an event.
OG0076.2(3.2 to 10.2)
OG0085.9(0.9 to 6.3)
OG0095.6(0.5 to 8.4)
OG0108.2(0.7 to 24.3)
OG0117.9(3.3 to 11.9)
OG0122.2(1.0 to 4.7)
OG002
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
OG003
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG004
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG005
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG006
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG007
Group C Phase 1b/2 ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG008
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
Units
Counts
Participants
OG0003
OG00150
OG0025
OG0036
OG0048
OG00517
OG00614
OG00735
OG0087
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003100.0
OG004100.0
OG005100.0
OG006100.0
OG007100.0
OG008100.0
OG002
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
OG003
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG004
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG005
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG006
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
OG007
Group C Phase 1b/2 ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
OG008
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.