Study of Vidaza Versus Conventional Care Regimens for the... | NCT01074047 | Trialant
NCT01074047
Sponsor
Celgene
Status
Completed
Last Update Posted
Aug 29, 2017Actual
Enrollment
488Actual
Phase
Phase 3
Conditions
Acute Myeloid Leukemia
Interventions
Azacitidine
Conventional Care Regimen
Countries
United States
Australia
Austria
Belgium
Canada
China
Czechia
France
Germany
Israel
Italy
Netherlands
Poland
Russia
South Korea
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01074047
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AZA-AML-001
Secondary IDs
Not provided
Brief Title
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)
Official Title
A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia
Acronym
Not provided
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
Aug 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 1, 2010Actual
Primary Completion Date
Jan 22, 2014Actual
Completion Date
Jul 25, 2016Actual
First Submitted Date
Feb 16, 2010
First Submission Date that Met QC Criteria
Feb 22, 2010
First Posted Date
Feb 24, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 22, 2015
Results First Submitted that Met QC Criteria
Feb 10, 2015
Results First Posted Date
Feb 26, 2015Estimated
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
Aug 25, 2017
Last Update Posted Date
Aug 29, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.
Detailed Description
Not provided
Conditions Module
Conditions
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia
Cytarabine
Vidaza
azacitidine
Intensive Chemotherapy
Low Dose Cytarabine
Celgene
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
488Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Azacitidine
Experimental
Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Drug: Azacitidine
Conventional Care Regimen
Active Comparator
Conventional Care Regimen
Drug: Conventional Care Regimen
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Azacitidine
Drug
75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Azacitidine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Kaplan-Meier Estimates for Overall Survival
Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.
Day 1 (randomization) to 40 months
Secondary Outcomes
Measure
Description
Time Frame
One-year Overall Survival Rate
Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.
From Day 1 (randomization) to 40 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of one of the following
Newly diagnosed de novo acute myeloid leukemia (AML)
AML secondary to myelodysplastic syndromes (MDS)
AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
Bone marrow blasts >30%
Age ≥ 65 years
Easter Cooperative Oncology Group (ECOG) 0-2
Exclusion Criteria:
Previous cytotoxic or biologic treatment for AML (except hydroxyurea)
Previous treatment with azacitidine, decitabine or cytarabine
Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)
AML French American British subtype (FAB M3)
AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
Prior bone marrow or stem cell transplantation
Candidate for allogeneic bone marrow or stem cell transplant
Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
Malignant hepatic tumors
Uncontrolled systemic infection
Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C
Use of any experimental drug or therapy within 28 days prior to Day 1
Seymour JF, Dohner H, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Del Castillo TB, Al-Ali HK, Falantes J, Stone RM, Minden MD, Weaver J, Songer S, Beach CL, Dombret H. Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens. BMC Cancer. 2017 Dec 14;17(1):852. doi: 10.1186/s12885-017-3803-6.
This was a multicenter, international Phase 3 study conducted at 107 investigational sites in 18 countries including South Korea, China, Taiwan, Australia, Canada, United States, Poland, Russia, Czech Republic, Israel, France, Italy, Spain, Germany, United Kingdom, Belgium, Austria and the Netherlands.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
FG001
Periods
Title
Milestones
Reasons Not Completed
Treatment Phase
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Turkey (Türkiye)
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
Parallel 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
Vidaza
Conventional Care Regimen
Drug
Physician pre-selects prior to randomization from one of the following:
Intensive chemotherapy (cytarabine 100-200 mg/m^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles
Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
Best Supportive Care only; until study end
Conventional Care Regimen
Event-free Survival (EFS)
Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.
Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months
Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
Relapse-free survival was defined as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurred first. Participants who were still alive and in continuous CR or CRi were censored at the date of their last response assessment.
Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months
Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)
A complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods), an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. A CR with incomplete blood count recovery (CRi) is defined as <5% BM blasts with the ANC count < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Where the date of the hematology assessment used is the earliest on or following the date of the BM sample up to 8 days after the BM date.
Day 1 (randomization) to 40 months
Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates
The time from the date CR or CRi was first documented until the date of documented relapse from CR/CRi. Duration of remission was defined only for those participants who achieved a CR or CRi, as determined by the IRC. Participants who were lost to follow-up without documented relapse, or were alive at last follow-up without documented relapse were censored at the date of their last response assessment.
Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.
The CRc is a normal karyotype defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) is when the following criteria are met: 1) CR criteria met and 2) an abnormal karyotype is present at baseline and 3) there is reversion to normal karyotype at the time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment
Day 1 (randomization) to 40 months
Number of Participants With Adverse Events (AEs)
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to Cycle 3; at approximately 3 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to Cycle 5, at approximately 5 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to Cycle 7, at approximately 7 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to Cycle 9, at approximately 9 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to End of Study; at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to end of study, at approximately 11-12 months
Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
Day 1 (randomization) to 40 months
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Day 1 (randomization) to 40 months
HRU: Number of Participants Receiving Transfusions
Count of study participants who had transfusions during the treatment phase. HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
Day 1 (randomization) to 40 months
HRU: Rate of Transfusions Per Patient Year
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of transfusions per patient year was calculated as the total number of transfusions divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Day 1 (randomization) to 40 months
Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days
Houston
Texas
77030
United States
Prince of Wales Hospital
Randwick
New South Wales
2031
Australia
Royal Adelaide Hospital
Adelaide
South Australia
5000
Australia
Peter MacCallum Cancer Centre
East Melbourne
Victoria
3002
Australia
Western Hospital
Footscray
Victoria
3011
Australia
Royal Melbourne Hospital
Melbourne
Victoria
3050
Australia
St Vincent's Hospital
Fitzroy
3065
Australia
Wilhelminenspital, I Medizinische Abt.
Vienna
State of Vienna
1160
Austria
Klinikum Wels-Grieskirchen GmbH
Wels
Upper Austria
4600
Austria
Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung
Salzburg
5020
Austria
Grand Hôpital de Charleroi
Charleroi
Hainaut
6000
Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir
Namur
5530
Belgium
Universitair Ziekenhuis Gent
Ghent
Oost-vlaanderen
9000
Belgium
Algemeen Ziekenhuis Sint-Jan
Bruges
West-vlaanderen
8000
Belgium
Centre Hospitalier de Jolimont-Lobbes
La Louvière
7100
Belgium
University of Alberta Hospital
Edmonton
Alberta
T6G 2B7
Canada
Cancer Care Manitoba
Winnipeg
Manitoba
R3E 0V9
Canada
Queen Elizabeth II Health Sciences Centre
Halifax
Nova Scotia
B3H 2Y9
Canada
Ottawa Hospital General Campus
Ottawa
Ontario
K1H8L6
Canada
Sunnybrook Odette Cancer Centre
Toronto
Ontario
M4N 3M5
Canada
Hopital Maisonneuve-Rosemont
Montreal
Quebec
H1T 2M4
Canada
Centre Hospitalier de l'Université de Montréal pavilion Notre Dame
Montreal
Quebec
H2L 4M1
Canada
Hopital du Sacre Coeur de Montréal
Montreal
Quebec
H4J 1C5
Canada
Tom Baker Cancer Centre
Calgary
T2N 2T9
Canada
Princess Margaret Hospital
Ontario
M5G 2M9
Canada
The Third Hospital of Peking University
Beijing
100083
China
Peking Union Medical College Hospital
Beijing
100730
China
Peoples Hospital of Jiangsu Province
Jiangsu
210029
China
Shanghai Ruijin Hospital
Shanghai
200025
China
Shanghai Changhai Hospital,the Second Military Medical University
Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre
Strasbourg
Alsace
67091
France
Centre Hopitalier Universitaire Dupuytren
Limoges
Limousin Lorraine
87042
France
Centre Hospitalier Universitaire de Toulouse
Toulouse
Midi-pyrénées
31059
France
Centre Hospitalier Universitaire de Nice
Nice
Nice
06202
France
CHRU d'Angers
Angers
Pays de la Loire Region
49933
France
Centre Hospitalier Universitaire Nantes, Hotel Dieu
Nantes
Pays de la Loire Region
44093
France
Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud
Amiens
Picardie
80054
France
Hôpital de la Conception
Marseille
Provence-Alpes-Côte d'Azur Region
13385
France
Centre Hospitalier de la Cote Basque
Aquitaine
64109
France
Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot
Lyon
69437
France
Hospital Avicenne, Service d'hematologie Clinique
Bobigny
Île-de-France Region
93009
France
Hopital Percy Clamart
Clamart
Île-de-France Region
92141
France
Hôpital Saint Louis
Paris
Île-de-France Region
75475
France
Universitatsklinikum Heidelberg
Heidelberg
Baden-Wurttemberg
69120
Germany
Universitätsklinikum Ulm
Ulm
Baden-Wurttemberg
89081
Germany
University of Rostock, Div. of Haematology and Oncology
Rostock
Mecklenburg-Vorpommern
18057
Germany
Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie
Essen
Nordrhein-Westfallen
45122
Germany
Heinrich-Heine-Universität Düsseldorf
Düesseldorf
North Rhine-Westphalia
40211
Germany
Universitätsklinikum Leipzig
Leipzig
Saxony
04103
Germany
Universitätsklinikum Jena
Jena
Thuringia
07747
Germany
Soroka Medical Center
Beersheba
Beersheva
84101
Israel
Assaf Harofeh Medical Centre
Beer Yaakov
70300
Israel
Shaare Zedek Medical Center
Jerusalem
91031
Israel
Hadassah Medical Center
Jerusalem
91120
Israel
Rabin Medical Center
Petah Tikva
49100
Israel
Sourasky Medical Center
Tel Aviv
64239
Israel
Chaim Sheba Medical Center - Tel Hashomer, Heart Institute
Tel Litwinsky
52621
Israel
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture
Potenza
85028
Italy
Azienda Sanitaria Ospedaliera "San Luigi Gonzaga"
Orbassano
Turin
10043
Italy
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria
15121
Italy
Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona
Ancona
60126
Italy
Azienda Ospedaliera Policlinico di Bari
Bari
70124
Italy
Azienda Ospedaliera Sant'Orsola Malpighi
Bologna
40138
Italy
Azienda Ospedaliero-Universitaria Careggi
Florence
50134
Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria
89100
Italy
Azienda Policlinico Umberto I di Roma
Roma
00161
Italy
Policlinico Universitario Agostino Gemelli
Roma
00168
Italy
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
Udine
33100
Italy
Ospedale di Circolo e Fondazione Macchi
Varese
21100
Italy
Universitair Medisch Centrum Groningen
Groningen
9700 RB
Netherlands
Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw
Lower Silesian Voivodeship
50-367
Poland
Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
Wroclaw
Lower Silesian Voivodeship
53-439
Poland
Instytut Hematologii i Transfuzjologii
Warsaw
Masovian Voivodeship
02-776
Poland
Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice
Silesian Voivodeship
40-032
Poland
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
Lódz
Łódź Voivodeship
93-510
Poland
City Clinical Hospital n.a. S. P. Botkin
Moscow
125284
Russia
State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital"
Nizhny Novgorod
603126
Russia
Saint Petersburg State Academician I.P. Pavlov Medical University
Saint Petersburg
197089
Russia
Saratov State Medical University
Saratov
410 028
Russia
Central City Hospital # 7
Yekaterinburg
620137
Russia
Samsung Medical Center
Gangnam-gu
Seoul
135-710
South Korea
Seoul National University Hospital
Jongno-gu
Seoul
110-774
South Korea
Yonsei University Health System
Seodaemun-gu
Seoul
120-752
South Korea
Kyungpook National University Hospital
Daegu
700-721
South Korea
Seoul Saint Mary's Hospital Seocho-gu
Seoul
137-701
South Korea
Asan Medical Center
Seoul
138-736
South Korea
Korea University Hospital at Guro
Seoul
152-703
South Korea
Hospital Son Dureta
Palma de Mallorca
Balearic Islands
07014
Spain
Hospital Son Llàtzer
Palma de Mallorca
Balearic Islands
07198
Spain
Hospital Central de Asturias
Oviedo
Principality of Asturias
33006
Spain
Hospital Clinic i Provincial de Barcelona
Barcelona
08036
Spain
Hospital General Universitario Gregorio Marañon
Madrid
28009
Spain
Hospital Universitario de Salamanca
Salamanca
37007
Spain
Hospital Universitario Virgen del Rocío
Seville
41013
Spain
Hospital Universitario La Fe
Valencia
46009
Spain
Chang Gung Memorial Hospital, Kaohsiung
Niao-Sung Hsiang
Kaohsiung
83301
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
Taipei Veterans General Hospital Pei-Tou District
Taipei
11217
Taiwan
Royal Marsden Hospital
Sutton
Surrey
SM2 5PT
United Kingdom
Royal Bournemouth Hospital
Bournemouth
BH7 7DW
United Kingdom
Barts and the London NHS Trust
London
EC1A 7BE
United Kingdom
King's College Hospital
London
SE5 9RS
United Kingdom
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom
Churchill Hospital
Oxford
OX3 9DS
United Kingdom
New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom
Derived
Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Dohner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.
Conventional Care Regimens (CCR)
CCRs included:
1 Intensive Chemotherapy: Cytarabine 100-200 mg/m2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m² QD or Idarubicin 9-12 mg/m² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed
2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC
3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
FG000241 subjects
FG001247 subjects
Treated Population
FG000236 subjects5 patients not treated with any drug regimen
FG001240 subjects7 patients not treated with any drug regimen
Safety Population
FG000236 subjectsReceived at least one dose of study medication and had at least 1 post dose safety assessment
FG001235 subjectsReceived at least one dose of study medication and had at least 1 post dose safety assessment
Evaluable Population
FG000179 subjectsDid not meet criteria for exclusion, received ≥1 cycle of treatment and had ≥ 1 efficacy assessment
FG001191 subjectsDid not meet criteria for exclusion, received ≥1 cycle of treatment and had ≥ 1 efficacy assessment
COMPLETED
FG00024 subjectsParticipants who were continuing study treatment at the time of study closure
FG00113 subjectsParticipants who were continuing study treatment at the time of study closure
NOT COMPLETED
FG000217 subjects
FG001234 subjects
Type
Comment
Reasons
Adverse Event
FG00089 subjects
FG00166 subjects
Disease Progression
FG00016 subjects
FG00121 subjects
Withdrawal by Subject
FG00027 subjects
FG00148 subjects
Death
FG00053 subjects
FG00158 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
Miscellaneous
FG00032 subjects
FG00139 subjects
Survival Follow-Up Phase
Type
Comment
Milestone Data
STARTED
FG000140 subjects
FG001163 subjects
COMPLETED
FG00016 subjects
FG00127 subjects
NOT COMPLETED
FG000124 subjects
FG001136 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0005 subjects
FG0018 subjects
Lost to Follow-up
FG0002 subjects
FG001
Extension Phase
Type
Comment
Milestone Data
STARTED
FG00022 subjects2 participants did not enroll in the extension period.
FG0010 subjects
Safety Population
FG00022 subjectsParticipants who enrolled in the extension phase
FG0010 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
NOT COMPLETED
FG00022 subjects
FG0010 subjects
Type
Comment
Reasons
Physician Decision
FG0001 subjects
FG0010 subjects
Adverse Event
FG0005 subjects
FG001
The intent-to-treat (ITT) population is defined as all participants who were randomized, independent of whether they received study treatment or not.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
BG001
Conventional Care Regimens (CCR)
#1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. Consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed. # 2 Low-dose cytarabine 20 mg SC twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only includes transfusion of blood products, antibiotics, antifungals and nutritional help.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000241
BG001247
BG002488
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00075.4± 5.60
BG00175.1± 5.57
BG00275.2± 5.58
Age, Customized
Number
participants
Title
Denominators
Categories
<75 years
Title
Measurements
BG000103
BG001120
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000102
BG00198
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity), 1 = Restricted activity but ambulatory, 2 = Ambulatory but unable to carry out work activities, 3 = Limited Self Care; 4 = Completely Disabled, No self care (Least Favorable Activity)
Number
participants
Title
Denominators
Categories
0 = Fully Active
Title
Measurements
BG00054
BG001
World Health Organization Acute Myeloid Leukemia (AML) Classification
WHO categories include:
Those with AML with recurrent genetic abnormalities. Includes subtypes with multiple chromosome translocations and mutations.
Those with AML with myelodysplasia-related changes. Includes those with prior myelodysplastic syndrome (MDS) or myeloproliferative disease and has transformed to AML.
Those with therapy related myeloid neoplasms and have had prior chemotherapy and/or radiation and subsequently develop AML or MDS
Those with AML not otherwise specified and include subtypes that do not fall into the above categories.
Number
participants
Title
Denominators
Categories
AML with myelodysplasia-related changes
Title
Measurements
BG00075
BG001
Bone Marrow-Blasts Counts
Baseline clinical characteristics, including percentage of bone marrow blasts were assessed centrally and locally. Central values are included here. Baseline blasts were the last non-missing value on or prior to the date of randomization. The bone marrow blasts cells are not typically found in the circulating blood of healthy individuals. Abnormal immature white blood cells (blasts) fill the bone marrow and spill into the bloodstream.
Mean
Standard Deviation
Percentage of Bone Marrow Blasts
Title
Denominators
Categories
Title
Measurements
BG00066.6± 24.71
BG001
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
Kaplan-Meier Estimates for Overall Survival
Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.
The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored
Posted
Median
95% Confidence Interval
months
Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000241
OG001247
Title
Denominators
Categories
Title
Measurements
OG00010.4(8.0 to 12.7)
OG0016.5(5.0 to 8.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
The p-value is two-sided from an unstratified log-rank test
0.0829
Hazard Ratio (HR)
0.84
2-Sided
95
0.69
1.02
The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.
Superiority or Other
OG000
Secondary
One-year Overall Survival Rate
Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.
The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored
Posted
Number
95% Confidence Interval
percentage of participants
From Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Secondary
Event-free Survival (EFS)
Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.
The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored
Posted
Median
95% Confidence Interval
months
Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Secondary
Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
Relapse-free survival was defined as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurred first. Participants who were still alive and in continuous CR or CRi were censored at the date of their last response assessment.
Participants who achieved a CR or CRi
Posted
Median
95% Confidence Interval
months
Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Secondary
Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)
A complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods), an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. A CR with incomplete blood count recovery (CRi) is defined as <5% BM blasts with the ANC count < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Where the date of the hematology assessment used is the earliest on or following the date of the BM sample up to 8 days after the BM date.
The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored
Posted
Number
percentage of participants
Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Secondary
Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates
The time from the date CR or CRi was first documented until the date of documented relapse from CR/CRi. Duration of remission was defined only for those participants who achieved a CR or CRi, as determined by the IRC. Participants who were lost to follow-up without documented relapse, or were alive at last follow-up without documented relapse were censored at the date of their last response assessment.
Includes those who achieved a CR or CRi and assessed by the IRC; numbers of ITT participants in each treatment group
Posted
Median
95% Confidence Interval
months
Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Secondary
Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.
The CRc is a normal karyotype defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) is when the following criteria are met: 1) CR criteria met and 2) an abnormal karyotype is present at baseline and 3) there is reversion to normal karyotype at the time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment
The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored
Posted
Number
participants
Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Secondary
Number of Participants With Adverse Events (AEs)
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Safety population = all randomized participants who received at least 1 dose of study drug and had 1 post-dose safety assessment. Because the BSC only regimen consisted of blood products or antibiotics given as needed, those assigned to BSC only were included in the safety population if they had at least 1 post-randomization safety assessment.
Posted
Number
participants
Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
Secondary
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 3; at approximately 3 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
Secondary
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 5, at approximately 5 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
Secondary
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 7, at approximately 7 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
Secondary
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. .
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 9, at approximately 9 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
Secondary
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to End of Study; at approximately 11-12 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 3, at approximately 3 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 5, at approximately 5 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 7, at approximately 7 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. The analysis included 157 from the azacitidine group and 134 in the CCR group, a smaller number than the ITT population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 9, at approximately 9 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to end of study, at approximately 11-12 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 3, at approximately 3 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 5, at approximately 5 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 7, at approximately 7 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 9, at approximately 9 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to end of study, at approximately 11-12 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 3, at approximately 3 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 5, at approximately 5 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 7, at approximately 7 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to Cycle 9, at approximately 9 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.
Posted
Mean
Standard Deviation
units on a scale
Baseline to end of study, at approximately 11-12 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
Secondary
Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.
Posted
Number
participants
Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Secondary
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.
Posted
Number
hospitalizations per patient year
Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Secondary
HRU: Number of Participants Receiving Transfusions
Count of study participants who had transfusions during the treatment phase. HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.
Posted
Number
participants
Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Secondary
HRU: Rate of Transfusions Per Patient Year
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of transfusions per patient year was calculated as the total number of transfusions divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.
Posted
Number
transfusions per patient year
Day 1 (randomization) to 40 months
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
OG001
Conventional Care Regimen
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Secondary
Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Safety population includes those enrolled in the extension phase who received at least one dose of study drug.
Posted
Number
participants
From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days
participants
participants
ID
Title
Description
OG000
Azacitidine (AZA)
Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
Time Frame
From first dose to 1) last dose + 28 days for azacitidine and low-dose cytarabine; 2) last dose + 70 days for intensive chemotherapy; 3) discontinuation for BSC only. Median duration was 191.5, 65.0, 125.0, 124.5 and 360.0 days for each group respectively
Description
3) discontinuation for BSC only. Median duration was 191.5, 65.0, 125.0, 124.5 and 360.0 days for each group respectively.
AEs reported for the Azacitidine group are those that occurred in the treatment phase, AEs reported in the Azacitidine extension group occurred during extension phase
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
Azacitidine
Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion
188
236
226
236
EG001
BSC Only
Transfusion of blood products, antibiotics, antifungals and nutritional help
30
40
33
40
EG002
Low-dose Cytarabine
Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC
118
153
151
153
EG003
Intensive Chemotherapy
Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed
27
42
42
42
EG004
Azacitidine-extension
Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
10
22
18
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
AGRANULOCYTOSIS
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG0030 affected42 at risk
EG0040 affected22 at risk
ANAEMIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG00010 affected236 at risk
EG0011 affected40 at risk
EG00211 affected153 at risk
EG003
DISSEMINATED INTRAVASCULAR COAGULATION
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
FEBRILE BONE MARROW APLASIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0023 affected153 at risk
EG003
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG00059 affected236 at risk
EG00112 affected40 at risk
EG00238 affected153 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0011 affected40 at risk
EG0023 affected153 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0006 affected236 at risk
EG0010 affected40 at risk
EG00214 affected153 at risk
EG003
THROMBOTIC THROMBOCYTOPENIC PURPURA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ACUTE CORONARY SYNDROME
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ACUTE LEFT VENTRICULAR FAILURE
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ACUTE MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0007 affected236 at risk
EG0011 affected40 at risk
EG0023 affected153 at risk
EG003
CARDIAC ARREST
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
CARDIAC FAILURE ACUTE
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
CARDIO-RESPIRATORY ARREST
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CARDIOVASCULAR INSUFFICIENCY
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
ISCHAEMIC CARDIOMYOPATHY
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
LEFT VENTRICULAR FAILURE
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PERICARDIAL EFFUSION
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PERICARDITIS
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
VENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CATARACT
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CONJUNCTIVAL HAEMORRHAGE
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
ANAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0021 affected153 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0010 affected40 at risk
EG0024 affected153 at risk
EG003
DIVERTICULUM INTESTINAL
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
DUODENAL ULCER HAEMORRHAGE
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ENTERITIS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
ENTEROCOLITIS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0011 affected40 at risk
EG0024 affected153 at risk
EG003
HAEMATEMESIS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ILEUS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
INTESTINAL ISCHAEMIA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
MELAENA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
MOUTH HAEMORRHAGE
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
RECTAL ULCER
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ASTHENIA
General disorders
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0011 affected40 at risk
EG0023 affected153 at risk
EG003
CHEST PAIN
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
CHILLS
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
DEATH
General disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
FATIGUE
General disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
GENERAL PHYSICAL HEALTH DETERIORATION
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
HYPERTHERMIA
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
INJECTION SITE EXTRAVASATION
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
INJECTION SITE REACTION
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
MALAISE
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
MULTI-ORGAN FAILURE
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
PAIN
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PYREXIA
General disorders
MedDRA 16.1
Systematic Assessment
EG00025 affected236 at risk
EG0013 affected40 at risk
EG00216 affected153 at risk
EG003
SUDDEN CARDIAC DEATH
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
SUDDEN DEATH
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CHOLANGITIS
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CHOLECYSTITIS
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CHOLECYSTITIS ACUTE
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HEPATIC FAILURE
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ANAPHYLACTIC SHOCK
Immune system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ABSCESS NECK
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ABSCESS SOFT TISSUE
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ACUTE SINUSITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
AEROMONA INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ANAL ABSCESS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ARTHRITIS INFECTIVE
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ASPERGILLUS INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
BRONCHOPNEUMONIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0011 affected40 at risk
EG0021 affected153 at risk
EG003
BRONCHOPULMONARY ASPERGILLOSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0014 affected40 at risk
EG0023 affected153 at risk
EG003
CELLULITIS ORBITAL
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CLOSTRIDIUM DIFFICILE COLITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
CLOSTRIDIUM DIFFICILE INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
CORYNEBACTERIUM SEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
DEVICE RELATED SEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ENTEROBACTER PNEUMONIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ENTEROCOCCAL BACTERAEMIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0021 affected153 at risk
EG003
ENTEROCOCCAL SEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
EPIGLOTTITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ESCHERICHIA BACTERAEMIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ESCHERICHIA INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ESCHERICHIA SEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
FURUNCLE
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
GASTROENTERITIS CLOSTRIDIAL
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
GASTROINTESTINAL FUNGAL INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
GROIN ABSCESS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
INFECTED CYST
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
KLEBSIELLA BACTERAEMIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
KLEBSIELLA SEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
LIVER ABSCESS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
LOBAR PNEUMONIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0011 affected40 at risk
EG0021 affected153 at risk
EG003
LUNG ABSCESS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
MUMPS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
NEUTROPENIC SEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0007 affected236 at risk
EG0012 affected40 at risk
EG0024 affected153 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
OROPHARYNGITIS FUNGAL
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PARAINFLUENZAE VIRUS INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PERIORBITAL CELLULITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
PERIRECTAL ABSCESS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PERITONITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
PHARYNGOTONSILLITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00048 affected236 at risk
EG0013 affected40 at risk
EG00229 affected153 at risk
EG003
PNEUMONIA FUNGAL
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PNEUMONIA KLEBSIELLA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PNEUMONIA MYCOPLASMAL
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PNEUMONIA PARAINFLUENZAE VIRAL
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PNEUMONIA PSEUDOMONAS AERUGINOSA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PNEUMONIA STAPHYLOCOCCAL
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PNEUMONIA STREPTOCOCCAL
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PSEUDOMEMBRANOUS COLITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PSEUDOMONAL BACTERAEMIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PSEUDOMONAL SEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0012 affected40 at risk
EG0022 affected153 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00012 affected236 at risk
EG0011 affected40 at risk
EG0029 affected153 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0011 affected40 at risk
EG0024 affected153 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
SINUSITIS FUNGAL
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
SOFT TISSUE INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
STAPHYLOCOCCAL BACTERAEMIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
STAPHYLOCOCCAL SEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
SYSTEMIC CANDIDA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0007 affected236 at risk
EG0011 affected40 at risk
EG0023 affected153 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
VAGINITIS GARDNERELLA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
VULVAL ABSCESS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ZYGOMYCOSIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ALLERGIC TRANSFUSION REACTION
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ANKLE FRACTURE
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CONCUSSION
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CRANIOCEREBRAL INJURY
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
SUBDURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
TENDON RUPTURE
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
TRANSFUSION REACTION
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
TROPONIN INCREASED
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
URINE OUTPUT DECREASED
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
CACHEXIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
FAILURE TO THRIVE
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
FLUID OVERLOAD
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
TUMOUR LYSIS SYNDROME
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HAEMARTHROSIS
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
SPINAL OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ACUTE MYELOID LEUKAEMIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG00026 affected236 at risk
EG00112 affected40 at risk
EG00217 affected153 at risk
EG003
CHLOROMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
LEUKAEMIC INFILTRATION BRAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
OVARIAN CANCER METASTATIC
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
TUMOUR FLARE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CEREBRAL HAEMORRHAGE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0012 affected40 at risk
EG0020 affected153 at risk
EG003
CEREBRAL INFARCTION
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
COGNITIVE DISORDER
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
CONVULSION
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
FEBRILE CONVULSION
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
HAEMORRHAGE INTRACRANIAL
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
LOSS OF CONSCIOUSNESS
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ORTHOSTATIC INTOLERANCE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
SUBARACHNOID HAEMORRHAGE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
TRANSIENT ISCHAEMIC ATTACK
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
BLADDER MASS
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
RENAL COLIC
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
RENAL FAILURE ACUTE
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
RENAL FAILURE CHRONIC
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
RENAL IMPAIRMENT
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
RENAL TUBULAR NECROSIS
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ACUTE PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
ACUTE RESPIRATORY DISTRESS SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0011 affected40 at risk
EG0023 affected153 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
LUNG DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
ORGANISING PNEUMONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
PNEUMONIA ASPIRATION
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PULMONARY ALVEOLAR HAEMORRHAGE
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
PULMONARY HAEMORRHAGE
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0021 affected153 at risk
EG003
PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0011 affected40 at risk
EG0026 affected153 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
PERIPHERAL ISCHAEMIA
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
PHLEBITIS
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
THROMBOPHLEBITIS SUPERFICIAL
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG00041 affected236 at risk
EG0013 affected40 at risk
EG00232 affected153 at risk
EG0037 affected42 at risk
EG0044 affected22 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG00028 affected236 at risk
EG0012 affected40 at risk
EG00221 affected153 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG00013 affected236 at risk
EG0012 affected40 at risk
EG00211 affected153 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG00022 affected236 at risk
EG0010 affected40 at risk
EG00215 affected153 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG00069 affected236 at risk
EG0011 affected40 at risk
EG00243 affected153 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG00060 affected236 at risk
EG0012 affected40 at risk
EG00237 affected153 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG00012 affected236 at risk
EG0012 affected40 at risk
EG0029 affected153 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0013 affected40 at risk
EG0022 affected153 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0014 affected40 at risk
EG0024 affected153 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00030 affected236 at risk
EG0013 affected40 at risk
EG00216 affected153 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00019 affected236 at risk
EG0010 affected40 at risk
EG0026 affected153 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00099 affected236 at risk
EG0019 affected40 at risk
EG00242 affected153 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00087 affected236 at risk
EG0015 affected40 at risk
EG00234 affected153 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0012 affected40 at risk
EG00214 affected153 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00014 affected236 at risk
EG0011 affected40 at risk
EG0027 affected153 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00011 affected236 at risk
EG0011 affected40 at risk
EG0028 affected153 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00093 affected236 at risk
EG0013 affected40 at risk
EG00243 affected153 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00020 affected236 at risk
EG0012 affected40 at risk
EG00214 affected153 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00053 affected236 at risk
EG0013 affected40 at risk
EG00224 affected153 at risk
EG003
ASTHENIA
General disorders
MedDRA 16.1
Systematic Assessment
EG00053 affected236 at risk
EG0018 affected40 at risk
EG00232 affected153 at risk
EG003
CATHETER SITE PAIN
General disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
CHILLS
General disorders
MedDRA 16.1
Systematic Assessment
EG00011 affected236 at risk
EG0011 affected40 at risk
EG0027 affected153 at risk
EG003
FATIGUE
General disorders
MedDRA 16.1
Systematic Assessment
EG00053 affected236 at risk
EG00110 affected40 at risk
EG00219 affected153 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
MedDRA 16.1
Systematic Assessment
EG00029 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA 16.1
Systematic Assessment
EG00012 affected236 at risk
EG0010 affected40 at risk
EG0021 affected153 at risk
EG003
INJECTION SITE REACTION
General disorders
MedDRA 16.1
Systematic Assessment
EG00030 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
MALAISE
General disorders
MedDRA 16.1
Systematic Assessment
EG0007 affected236 at risk
EG0012 affected40 at risk
EG0023 affected153 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA 16.1
Systematic Assessment
EG0008 affected236 at risk
EG0010 affected40 at risk
EG00214 affected153 at risk
EG003
OEDEMA
General disorders
MedDRA 16.1
Systematic Assessment
EG0008 affected236 at risk
EG0010 affected40 at risk
EG0023 affected153 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 16.1
Systematic Assessment
EG00055 affected236 at risk
EG0016 affected40 at risk
EG00233 affected153 at risk
EG003
PAIN
General disorders
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0015 affected40 at risk
EG0025 affected153 at risk
EG003
PYREXIA
General disorders
MedDRA 16.1
Systematic Assessment
EG00077 affected236 at risk
EG0017 affected40 at risk
EG00256 affected153 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00013 affected236 at risk
EG0013 affected40 at risk
EG0027 affected153 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected236 at risk
EG0010 affected40 at risk
EG0023 affected153 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00013 affected236 at risk
EG0012 affected40 at risk
EG0025 affected153 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0014 affected40 at risk
EG0024 affected153 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00015 affected236 at risk
EG0012 affected40 at risk
EG0028 affected153 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0009 affected236 at risk
EG0011 affected40 at risk
EG0025 affected153 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0010 affected40 at risk
EG00212 affected153 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0012 affected40 at risk
EG0024 affected153 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00018 affected236 at risk
EG0011 affected40 at risk
EG0025 affected153 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0013 affected40 at risk
EG00214 affected153 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0013 affected40 at risk
EG0027 affected153 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG00014 affected236 at risk
EG0012 affected40 at risk
EG0027 affected153 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0003 affected236 at risk
EG0010 affected40 at risk
EG0022 affected153 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 16.1
Systematic Assessment
EG00030 affected236 at risk
EG0013 affected40 at risk
EG0022 affected153 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG00061 affected236 at risk
EG0018 affected40 at risk
EG00233 affected153 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG00011 affected236 at risk
EG0012 affected40 at risk
EG0024 affected153 at risk
EG003
FLUID OVERLOAD
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0008 affected236 at risk
EG0012 affected40 at risk
EG0020 affected153 at risk
EG003
FLUID RETENTION
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0010 affected40 at risk
EG0020 affected153 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG00011 affected236 at risk
EG0011 affected40 at risk
EG00211 affected153 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0010 affected40 at risk
EG0026 affected153 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG00054 affected236 at risk
EG0016 affected40 at risk
EG00245 affected153 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG00021 affected236 at risk
EG0012 affected40 at risk
EG0029 affected153 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0009 affected236 at risk
EG0010 affected40 at risk
EG00212 affected153 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG00019 affected236 at risk
EG0012 affected40 at risk
EG0028 affected153 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG00033 affected236 at risk
EG0012 affected40 at risk
EG00211 affected153 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG00036 affected236 at risk
EG0015 affected40 at risk
EG00222 affected153 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG00012 affected236 at risk
EG0012 affected40 at risk
EG0024 affected153 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG00021 affected236 at risk
EG0012 affected40 at risk
EG0023 affected153 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG00026 affected236 at risk
EG0012 affected40 at risk
EG00211 affected153 at risk
EG003
ACUTE MYELOID LEUKAEMIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG00027 affected236 at risk
EG0012 affected40 at risk
EG00221 affected153 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG00042 affected236 at risk
EG0013 affected40 at risk
EG00215 affected153 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG00031 affected236 at risk
EG0011 affected40 at risk
EG00219 affected153 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0012 affected40 at risk
EG0022 affected153 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0006 affected236 at risk
EG0013 affected40 at risk
EG0023 affected153 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG00015 affected236 at risk
EG0014 affected40 at risk
EG0026 affected153 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG00014 affected236 at risk
EG0013 affected40 at risk
EG0028 affected153 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG00036 affected236 at risk
EG0012 affected40 at risk
EG00211 affected153 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0013 affected40 at risk
EG0028 affected153 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0007 affected236 at risk
EG0012 affected40 at risk
EG0023 affected153 at risk
EG003
RENAL FAILURE ACUTE
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0012 affected40 at risk
EG0023 affected153 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0005 affected236 at risk
EG0012 affected40 at risk
EG0021 affected153 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG00054 affected236 at risk
EG0016 affected40 at risk
EG00236 affected153 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG00041 affected236 at risk
EG0016 affected40 at risk
EG00235 affected153 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG00010 affected236 at risk
EG0012 affected40 at risk
EG0026 affected153 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG00029 affected236 at risk
EG0015 affected40 at risk
EG00221 affected153 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0009 affected236 at risk
EG0012 affected40 at risk
EG0024 affected153 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected236 at risk
EG0011 affected40 at risk
EG0020 affected153 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0012 affected40 at risk
EG00211 affected153 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG00012 affected236 at risk
EG0011 affected40 at risk
EG0022 affected153 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0009 affected236 at risk
EG0010 affected40 at risk
EG00210 affected153 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG00018 affected236 at risk
EG0010 affected40 at risk
EG0026 affected153 at risk
EG003
PETECHIAE
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG00012 affected236 at risk
EG0010 affected40 at risk
EG00216 affected153 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG00025 affected236 at risk
EG0011 affected40 at risk
EG00210 affected153 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG00026 affected236 at risk
EG0010 affected40 at risk
EG00214 affected153 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0004 affected236 at risk
EG0012 affected40 at risk
EG0025 affected153 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0007 affected236 at risk
EG0012 affected40 at risk
EG0022 affected153 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0012 affected40 at risk
EG0027 affected153 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG00016 affected236 at risk
EG0011 affected40 at risk
EG00213 affected153 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG00019 affected236 at risk
EG0013 affected40 at risk
EG00214 affected153 at risk
EG003
PHLEBITIS
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0007 affected236 at risk
EG0012 affected40 at risk
EG0024 affected153 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
The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation 60 days in advance of the submission and (ii) delete any confidential information of the sponsor and (iii) delay submission for up to 90 days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
Point of Contact
Title
Organization
Phone
Extension
Email
Anne McClain, Senior Manager Clinical Trial Disclosure
Celgene
888-260-1599
ClinicalTrialDisclosure@celgene.com
ID
Term
D015470
Leukemia, Myeloid, Acute
Ancestor Terms
ID
Term
D007951
Leukemia, Myeloid
D007938
Leukemia
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D001374
Azacitidine
Ancestor Terms
ID
Term
D001372
Aza Compounds
D009930
Organic Chemicals
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D012263
Ribonucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
Death
FG000116 subjects
FG001124 subjects
Alive at study closure
FG0001 subjects
FG0013 subjects
0 subjects
Disease Progression
FG0009 subjects
FG0010 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
Death
FG0005 subjects
FG0010 subjects
223
≥75 years
Title
Measurements
BG000138
BG001127
BG002265
200
Male
BG000139
BG001149
BG002288
57
BG002111
1 = Restrictive but Ambulatory
Title
Measurements
BG000132
BG001132
BG002264
2 = Ambulatory but unable to work
Title
Measurements
BG00055
BG00158
BG002113
3 = Limited Self Care
Title
Measurements
BG0000
BG0010
BG0020
4 = Completely disabled
Title
Measurements
BG0000
BG0010
BG0020
83
BG002158
Therapy-related myeloid neoplasms
Title
Measurements
BG0008
BG00112
BG002158
AML with recurrent genetic abnormalities
Title
Measurements
BG0005
BG0019
BG00214
AML not otherwise specified
Title
Measurements
BG000153
BG001143
BG002296
70.2
± 22.28
BG00268.5± 23.56
OG001
Log Rank
0.1009
Hazard Ratio (HR)
0.85
2-Sided
95
0.69
1.03
The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.
Superiority
Units
Counts
Participants
OG000241
OG001247
Title
Denominators
Categories
Title
Measurements
OG00046.5(40.1 to 52.7)
OG00134.3(28.3 to 40.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference
12.26
2-Sided
95
3.5
21.0
Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.
Superiority or Other
Units
Counts
Participants
OG000241
OG001247
Title
Denominators
Categories
Title
Measurements
OG0006.7(5.0 to 8.8)
OG0014.8(3.8 to 6.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median is estimated from a Kaplan-Meier distribution of EFS
Log Rank
2 sided unstratified
0.1495
Hazard Ratio (HR)
0.87
2-Sided
95
0.72
1.05
The hazard ratio is from an unstratified Cox proportional hazards model.
Superiority or Other
Units
Counts
Participants
OG00067
OG00162
Title
Denominators
Categories
Title
Measurements
OG0009.3(6.7 to 12.4)
OG00110.5(7.3 to 12.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median is estimated from a Kaplan-Meier distribution of RFS
Log Rank
2 sided unstratified
0.5832
Hazard Ratio (HR)
1.11
2-Sided
95
0.75
1.66
The hazard ratio is from an unstratified Cox proportional hazards model.
Superiority or Other
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000241
OG001247
Title
Denominators
Categories
Title
Measurements
OG00027.8
OG00125.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
P-value is from Fishers exact test
0.5384
Superiority or Other
Units
Counts
Participants
OG00067
OG00162
Title
Denominators
Categories
Title
Measurements
OG00010.4(7.2 to 15.2)
OG00112.3(9.0 to 17.0)
Units
Counts
Participants
OG000241
OG001247
Title
Denominators
Categories
Title
Measurements
OG0005
OG00115
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
P-value is from Fishers exact test
0.0376
Superiority or Other
OG001
Conventional Care Regimen #3 Best Supportive Care Only
Best supportive care included red blood cell (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic and/or antifungal therapy, and nutritional support.
OG002
Conventional Care Regimen #2 Low-dose Cytarabine
Low-dose cytarabine 20 mg SC injection twice a day (BID) for 10 days, every 28 days (optimally for at least 4 cycles) until the end of the study, unless participants were discontinued from the treatment. Best supportive care as needed, including antibiotics and transfusions, per physicians discretion.
OG003
Conventional Care Regimen #1 Intensive Chemotherapy
Induction Therapy included Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (IV) for 7 days plus daunorubicin 45 to 60 mg/m^² daily IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV daily for 3 days as an alternative to daunorubicin (Cycle 1). Consolidation Therapy (Cycle 2 and 3) Cytarabine 100-200 mg/m^2 as a continuous IV infusion for a total of 3 to 7 days plus daunorubicin 45 to 60 mg/m^² daily or Idarubicin 9-12 mg/m^² IV daily on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from commencement of induction therapy, upon recovery of absolute neutrophil count (ANC) to at least 1.0 x 10^9/L and platelets to at least 75 x 10^9/L. The second consolidation cycle, if given, started between Day 28 and Day 70 from commencement of the first consolidation therapy. Participants could receive BSC as needed, including antibiotics and transfusions, physicians discretion.
Units
Counts
Participants
OG000236
OG00140
OG002153
OG00342
Title
Denominators
Categories
At least one Treatment Emergent AE
Title
Measurements
OG000234
OG00136
OG002153
OG00342
At least one TEAE related to study drug
Title
Measurements
OG000188
OG0010
OG002124
OG003
Grade 3-4 adverse event
Title
Measurements
OG000207
OG00126
OG002141
OG003
Grade 3-4 adverse event related to any study drug
Title
Measurements
OG000125
OG0010
OG00290
OG003
At least one Grade 5 (leading to death) TEAE
Title
Measurements
OG00056
OG00123
OG00238
OG003
Grade 5 adverse event related to any study drug
Title
Measurements
OG00012
OG0010
OG00210
OG003
Serious TEAE
Title
Measurements
OG000188
OG00130
OG002118
OG003
Serious TEAE related to any study drug
Title
Measurements
OG00087
OG0010
OG00256
OG003
TEAE leading to discontinuation of study drug
Title
Measurements
OG000110
OG0010
OG00268
OG003
Study drug-related TEAE leading to discontinuation
Title
Measurements
OG00022
OG0010
OG00220
OG003
TEAE leading to study drug dose reduction
Title
Measurements
OG0008
OG0010
OG0022
OG003
TEAE leading to study drug dose interruption
Title
Measurements
OG000116
OG0010
OG00261
OG003
TEAE causing study drug dose reduction/disruption
Title
Measurements
OG00013
OG0010
OG0027
OG003
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000135
OG001101
Title
Denominators
Categories
Title
Measurements
OG000-1.5± 24.69
OG001-1.9± 27.54
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000112
OG00166
Title
Denominators
Categories
Title
Measurements
OG000-2.8± 27.36
OG001-7.1± 27.61
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00094
OG00153
Title
Denominators
Categories
Title
Measurements
OG000-6.1± 26.90
OG001-12.2± 30.45
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00080
OG00136
Title
Denominators
Categories
Title
Measurements
OG000-9.0± 27.90
OG001-10.2± 33.85
OG001
Conventional Care Regimens (CCR)
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00087
OG00180
Title
Denominators
Categories
Title
Measurements
OG0008.9± 33.54
OG0016.1± 34.19
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000136
OG001101
Title
Denominators
Categories
Title
Measurements
OG0005.1± 26.88
OG001-1.7± 30.69
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000112
OG00166
Title
Denominators
Categories
Title
Measurements
OG0003.9± 27.49
OG001-6.6± 28.18
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00094
OG00153
Title
Denominators
Categories
Title
Measurements
OG0000.4± 29.93
OG001-8.8± 28.61
Conventional Care Regimen
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00081
OG00136
Title
Denominators
Categories
Title
Measurements
OG000-4.9± 26.93
OG001-2.8± 26.87
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00087
OG00180
Title
Denominators
Categories
Title
Measurements
OG00012.6± 31.43
OG0016.3± 35.22
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000136
OG001102
Title
Denominators
Categories
Title
Measurements
OG000-4.2± 17.98
OG001-0.3± 18.85
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000112
OG00167
Title
Denominators
Categories
Title
Measurements
OG000-4.4± 19.25
OG001-1.3± 20.41
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00094
OG00154
Title
Denominators
Categories
Title
Measurements
OG0001.6± 18.75
OG0011.5± 23.08
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00081
OG00136
Title
Denominators
Categories
Title
Measurements
OG0003.5± 18.26
OG001-0.4± 22.81
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00087
OG00181
Title
Denominators
Categories
Title
Measurements
OG000-13.0± 26.74
OG001-9.4± 26.43
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000134
OG001101
Title
Denominators
Categories
Title
Measurements
OG0000.9± 20.97
OG0013.8± 26.42
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG000112
OG00166
Title
Denominators
Categories
Title
Measurements
OG0001.6± 22.50
OG0019.0± 24.82
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00094
OG00152
Title
Denominators
Categories
Title
Measurements
OG0005.1± 25.84
OG0018.7± 27.91
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00080
OG00136
Title
Denominators
Categories
Title
Measurements
OG0007.8± 27.28
OG00110.4± 23.09
CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
Units
Counts
Participants
OG00087
OG00180
Title
Denominators
Categories
Title
Measurements
OG000-4.4± 29.20
OG001-6.1± 27.90
Units
Counts
Participants
OG000157
OG001134
Title
Denominators
Categories
Title
Measurements
OG000139
OG001111
Units
Counts
Participants
OG000157
OG001134
Title
Denominators
Categories
Title
Measurements
OG0007.95
OG0014.82
Units
Counts
Participants
OG000157
OG001134
Title
Denominators
Categories
Title
Measurements
OG000154
OG001134
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
negative binomial regression analysis
0.0721
Relative Ratio
0.79
2-Sided
95
0.62
1.02
Superiority or Other
Units
Counts
Participants
OG000157
OG001134
Title
Denominators
Categories
Title
Measurements
OG00034.23
OG00136.04
Units
Counts
Participants
OG00022
Title
Denominators
Categories
At least one Treatment Emergent AE
Title
Measurements
OG00020
At least one TEAE related to study drug
Title
Measurements
OG00013
At least one Grade 3-4 adverse event
Title
Measurements
OG00013
At least 1 Grade 3-4 TEAE related to study drug
Title
Measurements
OG0007
At least 1 Grade 5 TEAE
Title
Measurements
OG0004
At least 1 Grade 5 TEAE related to study drug
Title
Measurements
OG0000
At least 1 serious TEAE
Title
Measurements
OG00010
At least 1 serious TEAE related to study drug
Title
Measurements
OG0001
At least one serious Grade 3-4 TEAE
Title
Measurements
OG0008
TEAE leading to discontinuation of study drug
Title
Measurements
OG0003
Study drug-related TEAE leading to discontinuation