Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC. | NCT01928576 | Trialant
NCT01928576
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Status
Completed
Last Update Posted
May 3, 2024Actual
Enrollment
143Actual
Phase
Phase 2
Conditions
Non-Small Cell Lung Cancer
Epigenetic Therapy
Interventions
Azacitidine
Entinostat
Nivolumab
CC-486 300
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT01928576
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
J1353
Secondary IDs
ID
Type
Description
Link
NA_00084192
Other Identifier
JHMIRB
119134
Other Grant/Funding Number
Rising Tide Foundation
117207
Other Grant/Funding Number
Stand Up To Cancer
121445
Other Grant/Funding Number
JH FAMRI
119134
Other Grant/Funding Number
Rhone-Poulenc ROrer
CA209-117
Other Identifier
Bristol-Myers Squibb
Brief Title
Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.
Official Title
A Phase II Study of Epigenetic Therapy With Azacitidine and Entinostat With Concurrent Nivolumab in Subjects With Metastatic Non-Small Cell Lung Cancer.
Acronym
NA_00084192
Organization
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Status Module
Record Verification Date
May 2024
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
Nov 6, 2013Actual
Primary Completion Date
Apr 4, 2023Actual
Completion Date
Apr 4, 2023Actual
First Submitted Date
Aug 21, 2013
First Submission Date that Met QC Criteria
Aug 23, 2013
First Posted Date
Aug 26, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 1, 2024
Results First Submitted that Met QC Criteria
May 1, 2024
Results First Posted Date
May 3, 2024Actual
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
May 1, 2024
Last Update Posted Date
May 3, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Collaborators
Name
Class
Rising Tide Foundation
OTHER
Stand Up To Cancer
OTHER
Bristol-Myers Squibb
INDUSTRY
Celgene
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
Response Rate
Detailed Description
Objective response rate to Nivolumab preceded by epigenetic priming. Response will be assessed by RECIST 1.1 criteria, baseline scans for this assessment will be the baseline scans done within 4 weeks of enrollment.
Conditions Module
Conditions
Non-Small Cell Lung Cancer
Epigenetic Therapy
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
143Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm C
Experimental
Nivolumab 3mg/kg every 2 weeks until progression
Drug: Nivolumab
Arm D
Experimental
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Drug: Azacitidine
Drug: Entinostat
Drug: Nivolumab
Arm E
Experimental
Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Drug: Azacitidine
Drug: Entinostat
Drug: Nivolumab
Arm F
Experimental
Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Azacitidine
Drug
Arm A
Arm D
Arm E
Arm F
5-AZA, Vidaza
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response
Percentage of participants with response to combination Nivolumab and epigenetic therapy. Response will be assessed by RECIST 1.1 criteria, where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
2 years
Secondary Outcomes
Measure
Description
Time Frame
Progression Free Survival
Number of months from the time of randomization until radiologic (per RECIST 1.1) or clinical progression or death, whichever comes first.
2 years
Time to Progression
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically proven stage IIIB, IV or recurrent non-small cell lung cancer. Patients must be willing to undergo a pre-treatment biopsy, either core needle biopsy or equivalent amount or via excisional specimen. (cytology specimen not acceptable for this purpose).
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. A CT scan of the abdomen and pelvis is not required for patients with no disease in these areas.
Age >18 years. Because no dosing or adverse event data are currently available on the use of azacitidine with entinostat, or of Nivolumab, in patients <18 years of age, children are excluded from this study.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Life expectancy of greater than 12 weeks.
Patients must have adequate organ and marrow function.
The effects of entinostat, azacitidine, and Nivolumab, on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for up to 23 weeks after the last dose of nivolumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men who are sexually active with women of childbearing potential must also use an adequate contraceptive method for up to 31 weeks after fhe last dose of nivolumab.
Ability to understand and the willingness to sign a written informed consent document.
All adenocarcinoma patients must be tested for ALK rearrangements and EGFR (Exon 19 Deletion and Exon 21 L8585R Substitution) mutations and must have been treated with EGFR or ALK TKI therapy if found to have an actionable alteration. If patients are KRAS positive, testing for ALK rearrangements and EGFR mutations is not applicable.
All patients should have been offered a platinum-based chemotherapy. For EGFR/ALK wild type patients, no more than two prior chemotherapy-based lines of therapy for advanced or metastatic NSCLC is permitted. For EGFR mutated or ALK translocated patients, no more than three prior lines of therapy for advanced or metastatic NSCLC is permitted. Patients who refuse platinum based chemotherapy, may be allowed to enroll if they meet all other criteria.
Patients who received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are eligible and the adjuvant or neoadjuvant chemotherapy will count as a line of therapy as above.
Subjects with recurrent disease > 6 months after adjuvant or neoadjuvant platinum-based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen given to treat the recurrences, are eligible and do not count as another line of therapy for advanced disease.
Subjects who received pemetrexed, bevacizumab, or erlotinib as maintenance therapy (nonprogressors with platinum-based doublet chemotherapy) and subsequently progressed after maintenance therapy, are eligible and do not count as a line of therapy. However, subject who received a tyrosine kinase inhibitor after failure of a prior platinum-based therapy, that tyrosine kinase inhibitor therapy would count as an additional line of therapy.
Patients who have been treated with prior standard of care PD-1/L1 agents, alone or in combination with chemotherapy, are eligible. Patients previously treated on clinical trials with non PD-1/PD-L1 immunotherapy agents are eligible. Patients who have been treated with a PD-1/L1 agent in more than 1 line of therapy (as standard of care or in clinical trial) are not eligible.
Arm-specific eligibility criteria
Arm D: Anti-PD-1/PD-L1 treatment naïve patients only
Arm E & F: Anti-PD-1/PD-L1 treatment experienced patients: Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) or recurrent (Arm F=more than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Patients must have disease amenable to biopsy at the time of enrollment as biopsies are required for study participation.
Exclusion Criteria:
Any active history of a known autoimmune disease. Subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Subjects with a history of interstitial lung disease that has required intubation in the past (i.e. such as Asthma or COPD).
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
Patients who are receiving any other anticancer therapy.
Patients with uncontrolled brain metastases. Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks without the use of steroids or on stable or decreasing dose of < 10mg daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of carcinomatous meningitis are not eligible.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to entinostat, azacitidine, or Nivolumab.
Known or suspected hypersensitivity to azacitidine or mannitol
Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because entinostat, azacitidine, and Nivolumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with entinostat, azacitidine, or Nivolumab breastfeeding should be discontinued if the mother is treated on this protocol.
HIV-positive patients are excluded. (Patients cannot have known history of HIV. Testing for it at baseline is not required unless it is suspected they may have it).
Patients with active hepatitis B or hepatitis C are excluded. (Patients cannot have known history of hepatitis B or hepatitis C. Testing for it at baseline is not required unless it is suspected they may have it).
Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Patients with malabsorption in the small intestine or other conditions that would preclude administration of oral medication.
Prior therapy with DNA methyltransferase therapy or HDAC inhibitor therapy.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
100 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Julie Brahmer, MD
Johns Hopkins University
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Southern California
Los Angeles
California
90033
United States
Sibley Memorial Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
43 patients were not eligible. The list of reasons for subjects not being eligible include Subject had did not have disease amenable to biopsy, Disease Progression, elevated creatinine, COVID-19, hyponatremia, patient declined, patient sent to hospice, deceased, history of pneumonitis, not have enough tissue for biopsy, central nervous system involvement, pericardial effusion, brain metastasis, and Hypoxemia.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ARM A
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 2 cycles
Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10
Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
FG001
ARM B
Every 28 days for 2 cycles
CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
FG002
Arm C
Nivolumab 3mg/kg every 2 weeks until progression
Nivolumab
FG003
Arm D
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
FG004
Arm E
Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
FG005
Arm F
Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00032 subjects
FG0017 subjects
FG00221 subjects
FG00314 subjects
FG0047 subjects
FG00519 subjects
COMPLETED
FG00032 subjects
FG0017 subjects
FG00221 subjects
FG00314 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ARM A
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 2 cycles Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10 Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
age data was missing for 1 participant in Arm F.
Outcome Measures Module
Outcome Measures
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
Objective Response
Percentage of participants with response to combination Nivolumab and epigenetic therapy. Response will be assessed by RECIST 1.1 criteria, where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
1 patient from ARM A and 1 patient from ARM C did not have documentation of resict reads to analysis.
Posted
Count of Participants
Participants
2 years
ID
Title
Description
OG000
ARM A
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 2 cycles
Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10
Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Adverse Events Module
Frequency Threshold
5
Time Frame
All Adverse events and Serious Adverse events data was collected during the treatment phase of the study and then at a 30 day follow up visit, up to 2 years. Death assessed up to 5 years post treatment.
Description
Not provided
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
ARM A
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 2 cycles
Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10
Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Anti-PD-1/PD-L1 treatment naïve patients only Every 28 days for 2 cycles Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10 Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg
Drug: Azacitidine
Drug: Entinostat
Drug: Nivolumab
Arm B
Experimental
Every 28 days for 2 cycles CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Drug: Nivolumab
Drug: CC-486 300
Entinostat
Drug
Arm A
Arm D
Arm E
Arm F
Nivolumab
Drug
Arm A
Arm B
Arm C
Arm D
Arm E
Arm F
Opdivo
CC-486 300
Drug
Arm B
Number of months from the time nivolumab begins until radiologic (per RECIST 1.1) or clinical progression is noted.
2 years
Overall Survival
Number of months from the time of randomization until death. Estimation will be by the Kaplan-Meier method.
2 years
Safety and Tolerability as Assessed by Number of Participants With Dose-limiting Toxicities
Number of participants who experience adverse events as defined by CTCAE v4.0 that require a dose reduction.
2 years
Washington D.C.
District of Columbia
20016
United States
Julie Brahmer, MD
Baltimore
Maryland
21224
United States
Julie Brahmer, MD
Baltimore
Maryland
21287
United States
UPMC Cancer Center- Hillman Cancer Center
Pittsburgh
Pennsylvania
15213
United States
7 subjects
FG00519 subjects
0 subjects
FG0050 subjects
BG001
ARM B
Every 28 days for 2 cycles CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
BG002
Arm C
Nivolumab 3mg/kg every 2 weeks until progression
Nivolumab
BG003
Arm D
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
BG004
Arm E
Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
BG005
Arm F
Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
BG006
Total
Total of all reporting groups
32
BG0017
BG00221
BG00314
BG0047
BG00519
BG006100
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00032
ParticipantsBG0017
ParticipantsBG00221
ParticipantsBG00314
ParticipantsBG0047
ParticipantsBG00518
ParticipantsBG00699
Title
Measurements
BG00062.7± 10
BG00167.3± 6.6
BG00264.2± 9
BG003
Age, Continuous
age data was missing for 1 participant in Arm F
Median
Full Range
years
Title
Denominators
Categories
ParticipantsBG00032
ParticipantsBG0017
ParticipantsBG00221
ParticipantsBG00314
ParticipantsBG0047
ParticipantsBG00518
ParticipantsBG00699
Title
Measurements
BG00063.5(45 to 83)
BG00167(58 to 76)
BG00262(53 to 83)
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Unknown
ParticipantsBG00032
ParticipantsBG0017
ParticipantsBG00221
ParticipantsBG00314
ParticipantsBG0047
ParticipantsBG00519
ParticipantsBG006100
Title
Measurements
BG0000
BG0010
BG0020
BG003
Female
ParticipantsBG00032
ParticipantsBG0017
ParticipantsBG00221
ParticipantsBG00314
Male
ParticipantsBG00032
ParticipantsBG0017
ParticipantsBG00221
ParticipantsBG00314
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00032
ParticipantsBG0017
ParticipantsBG00221
ParticipantsBG00314
ParticipantsBG0047
ParticipantsBG00519
ParticipantsBG006100
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG003
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00032
ParticipantsBG0017
ParticipantsBG00221
ParticipantsBG00314
ParticipantsBG0047
ParticipantsBG00519
ParticipantsBG006100
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG003
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
ParticipantsBG00032
ParticipantsBG0017
ParticipantsBG00221
ParticipantsBG00314
ParticipantsBG0047
ParticipantsBG00519
ParticipantsBG006100
Title
Measurements
BG00032
BG0017
BG00221
BG003
OG001
ARM B
Every 28 days for 2 cycles
CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
OG002
Arm C
Nivolumab 3mg/kg every 2 weeks until progression
Nivolumab
OG003
Arm D
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG004
Arm E
Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG005
Arm F
Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
Units
Counts
Participants
OG00031
OG0017
OG00220
OG00314
OG0047
OG00519
Title
Denominators
Categories
Title
Measurements
OG0004
OG0011
OG0025
OG0033
OG0041
OG0052
Secondary
Progression Free Survival
Number of months from the time of randomization until radiologic (per RECIST 1.1) or clinical progression or death, whichever comes first.
Posted
Median
95% Confidence Interval
months
2 years
ID
Title
Description
OG000
ARM A
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 2 cycles
Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10
Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
OG001
ARM B
Every 28 days for 2 cycles
CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
OG002
Arm C
Nivolumab 3mg/kg every 2 weeks until progression
Nivolumab
OG003
Arm D
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG004
Arm E
Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG005
Arm F
Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
Units
Counts
Participants
OG00032
OG0017
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.6(3.7 to 13.7)
OG0013.7(0.9 to NA)not estimable because the upper confidence limits for the survivor function in this cohort was never less than 50%
OG0025.7
Secondary
Time to Progression
Number of months from the time nivolumab begins until radiologic (per RECIST 1.1) or clinical progression is noted.
Posted
Median
95% Confidence Interval
months
2 years
ID
Title
Description
OG000
ARM A
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 2 cycles
Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10
Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
OG001
ARM B
Every 28 days for 2 cycles
CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
OG002
Arm C
Nivolumab 3mg/kg every 2 weeks until progression
Nivolumab
OG003
Arm D
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG004
Arm E
Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG005
Arm F
Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
Units
Counts
Participants
OG00032
OG0017
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.6(3.4 to 13.7)
OG0013.7(0.9 to NA)not estimable because the upper confidence limits for the survivor function in this cohort was never less than 50%
OG0025.7
Secondary
Overall Survival
Number of months from the time of randomization until death. Estimation will be by the Kaplan-Meier method.
Posted
Median
95% Confidence Interval
months
2 years
ID
Title
Description
OG000
ARM A
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 2 cycles
Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10
Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
OG001
ARM B
Every 28 days for 2 cycles
CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
OG002
Arm C
Nivolumab 3mg/kg every 2 weeks until progression
Nivolumab
OG003
Arm D
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG004
Arm E
Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG005
Arm F
Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
Units
Counts
Participants
OG00032
OG0017
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG00010.5(7.7 to 25.1)
OG0014(1.3 to NA)not estimable because the upper confidence limits for the survivor function in this cohort was never less than 50%
OG00216.9
Secondary
Safety and Tolerability as Assessed by Number of Participants With Dose-limiting Toxicities
Number of participants who experience adverse events as defined by CTCAE v4.0 that require a dose reduction.
Posted
Count of Participants
Participants
2 years
ID
Title
Description
OG000
ARM A
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 2 cycles
Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10
Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
OG001
ARM B
Every 28 days for 2 cycles
CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
OG002
Arm C
Nivolumab 3mg/kg every 2 weeks until progression
Nivolumab
OG003
Arm D
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG004
Arm E
Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
OG005
Arm F
Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
Units
Counts
Participants
OG00032
OG0017
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
22
32
4
32
32
32
EG001
ARM B
Every 28 days for 2 cycles
CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
6
7
1
7
7
7
EG002
Arm C
Nivolumab 3mg/kg every 2 weeks until progression
Nivolumab
12
21
1
21
21
21
EG003
Arm D
Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
5
14
0
14
14
14
EG004
Arm E
Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
7
7
2
7
7
7
EG005
Arm F
Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.
Azacitidine
Entinostat
Nivolumab
12
19
0
19
19
19
EG0000 events0 affected32 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Abdominal Pain
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
White blood cell decreased
Investigations
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected19 at risk
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected19 at risk
confusion
Psychiatric disorders
CTCAE 4.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
vomiting
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected19 at risk
Fever
General disorders
CTCAE 4.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Cardiac troponin T increased
Cardiac disorders
CTCAE 4.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
EG0006 events4 affected32 at risk
EG0010 events0 affected7 at risk
EG0025 events4 affected21 at risk
EG0037 events3 affected14 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected19 at risk
Absolute Lymphocytes Decreased
Investigations
CTCAE 4.0
Systematic Assessment
EG0006 events3 affected32 at risk
EG0013 events1 affected7 at risk
EG0023 events2 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0056 events2 affected19 at risk
Absolute neutrophil Count (ANC)decreased
Investigations
CTCAE 4.0
Systematic Assessment
EG0003 events2 affected32 at risk
EG0013 events2 affected7 at risk
EG0024 events2 affected21 at risk
EG0031 events1 affected14 at risk
EG0040 events0 affected7 at risk
EG0054 events1 affected19 at risk
Alanine Aminotransferase Increased
Investigations
CTCAE 4.0
Systematic Assessment
EG0006 events3 affected32 at risk
EG0011 events1 affected7 at risk
EG00214 events5 affected21 at risk
EG00314 events2 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
albumin decreased
Investigations
CTCAE 4.0
Systematic Assessment
EG0005 events4 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
alkaline phosphae increased
Investigations
CTCAE 4.0
Systematic Assessment
EG00012 events10 affected32 at risk
EG0012 events2 affected7 at risk
EG0024 events4 affected21 at risk
EG00341 events9 affected14 at risk
EG00418 events6 affected7 at risk
EG0051 events1 affected19 at risk
Alopecia
General disorders
CTCAE 4.0
Systematic Assessment
EG0005 events5 affected32 at risk
EG0010 events0 affected7 at risk
EG0023 events1 affected21 at risk
EG0032 events2 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Anemia
Investigations
CTCAE 4.0
Systematic Assessment
EG00031 events17 affected32 at risk
EG0019 events4 affected7 at risk
EG00222 events10 affected21 at risk
EG00329 events7 affected14 at risk
EG0046 events2 affected7 at risk
EG0058 events4 affected19 at risk
Anorexia
Metabolism and nutrition disorders
CTCAE 4.0
Systematic Assessment
EG00034 events19 affected32 at risk
EG0018 events5 affected7 at risk
EG00212 events8 affected21 at risk
EG0035 events2 affected14 at risk
EG0044 events3 affected7 at risk
EG0058 events5 affected19 at risk
Anxiety
Psychiatric disorders
CTCAE 4.0
Systematic Assessment
EG0009 events4 affected32 at risk
EG0013 events1 affected7 at risk
EG00210 events7 affected21 at risk
EG0035 events3 affected14 at risk
EG0040 events0 affected7 at risk
EG0054 events2 affected19 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
CTCAE 4.0
Systematic Assessment
EG0005 events2 affected32 at risk
EG0011 events1 affected7 at risk
EG0027 events4 affected21 at risk
EG0031 events1 affected14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected19 at risk
Aspartate aminotransferase increased
Investigations
CTCAE 4.0
Systematic Assessment
EG0009 events6 affected32 at risk
EG0013 events2 affected7 at risk
EG0028 events3 affected21 at risk
EG0039 events2 affected14 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected19 at risk
Back Pain
Musculoskeletal and connective tissue disorders
CTCAE 4.0
Systematic Assessment
EG00014 events8 affected32 at risk
EG0014 events3 affected7 at risk
EG0024 events4 affected21 at risk
EG0031 events1 affected14 at risk
EG0040 events0 affected7 at risk
EG0056 events4 affected19 at risk
Blurred Vision
Eye disorders
CTCAE 4.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected7 at risk
EG0022 events2 affected21 at risk
EG0032 events2 affected14 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected19 at risk
Chest Pain (Non-Cardiac)
Musculoskeletal and connective tissue disorders
CTCAE 4.0
Systematic Assessment
EG0009 events5 affected32 at risk
EG0011 events1 affected7 at risk
EG0023 events2 affected21 at risk
EG0031 events1 affected14 at risk
EG0041 events1 affected7 at risk
EG0054 events2 affected19 at risk
Chills
General disorders
CTCAE 4.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected7 at risk
EG0024 events3 affected21 at risk
EG0032 events2 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Confusion
Psychiatric disorders
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0012 events1 affected7 at risk
EG0022 events2 affected21 at risk
EG0031 events1 affected14 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected19 at risk
Constipation
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG00030 events15 affected32 at risk
EG00114 events5 affected7 at risk
EG00212 events7 affected21 at risk
EG00314 events11 affected14 at risk
EG0044 events3 affected7 at risk
EG0057 events5 affected19 at risk
Cough
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG00027 events16 affected32 at risk
EG0018 events4 affected7 at risk
EG00232 events16 affected21 at risk
EG00314 events3 affected14 at risk
EG0046 events3 affected7 at risk
EG00510 events6 affected19 at risk
creatine increased
Investigations
CTCAE 4.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected7 at risk
EG0025 events2 affected21 at risk
EG0032 events1 affected14 at risk
EG0040 events0 affected7 at risk
EG0053 events1 affected19 at risk
Dehydration
General disorders
CTCAE 4.0
Systematic Assessment
EG0005 events5 affected32 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected21 at risk
EG0038 events2 affected14 at risk
EG0041 events1 affected7 at risk
EG0052 events1 affected19 at risk
Depression
Psychiatric disorders
CTCAE 4.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0031 events1 affected14 at risk
EG0041 events1 affected7 at risk
EG0053 events3 affected19 at risk
Diarrhea
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG0009 events8 affected32 at risk
EG0012 events1 affected7 at risk
EG00213 events9 affected21 at risk
EG0031 events1 affected14 at risk
EG0041 events1 affected7 at risk
EG0054 events4 affected19 at risk
Dizziness
Nervous system disorders
CTCAE 4.0
Systematic Assessment
EG00010 events7 affected32 at risk
EG0014 events1 affected7 at risk
EG0024 events3 affected21 at risk
EG0034 events4 affected14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected19 at risk
Dry Mouth
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG0007 events5 affected32 at risk
EG0010 events0 affected7 at risk
EG0024 events3 affected21 at risk
EG0035 events3 affected14 at risk
EG0041 events1 affected7 at risk
EG0053 events3 affected19 at risk
Dry Skin
Skin and subcutaneous tissue disorders
CTCAE 4.0
Systematic Assessment
EG0004 events3 affected32 at risk
EG0011 events1 affected7 at risk
EG0024 events3 affected21 at risk
EG0032 events1 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Dysguesia
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG00011 events7 affected32 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected21 at risk
EG0033 events2 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Dyspepsia
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG00012 events9 affected32 at risk
EG0014 events3 affected7 at risk
EG0025 events4 affected21 at risk
EG0033 events2 affected14 at risk
EG0043 events2 affected7 at risk
EG0051 events1 affected19 at risk
Edema
Skin and subcutaneous tissue disorders
CTCAE 4.0
Systematic Assessment
EG00013 events9 affected32 at risk
EG0011 events1 affected7 at risk
EG0024 events3 affected21 at risk
EG0036 events2 affected14 at risk
EG0043 events3 affected7 at risk
EG0052 events1 affected19 at risk
Fatigue
General disorders
CTCAE 4.0
Systematic Assessment
EG00054 events26 affected32 at risk
EG00116 events7 affected7 at risk
EG00233 events15 affected21 at risk
EG00316 events9 affected14 at risk
EG0046 events5 affected7 at risk
EG00518 events8 affected19 at risk
Generalized weakness
Musculoskeletal and connective tissue disorders
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected7 at risk
EG0025 events4 affected21 at risk
EG0031 events1 affected14 at risk
EG0041 events1 affected7 at risk
EG0053 events1 affected19 at risk
Headache
Nervous system disorders
CTCAE 4.0
Systematic Assessment
EG0008 events6 affected32 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected21 at risk
EG00315 events7 affected14 at risk
EG0041 events1 affected7 at risk
EG0057 events4 affected19 at risk
Hoarseness
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0013 events1 affected7 at risk
EG0022 events1 affected21 at risk
EG0030 events0 affected14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected19 at risk
Hyperglycemia
Metabolism and nutrition disorders
CTCAE 4.0
Systematic Assessment
EG00011 events7 affected32 at risk
EG0010 events0 affected7 at risk
EG00283 events12 affected21 at risk
EG00313 events6 affected14 at risk
EG0040 events0 affected7 at risk
EG0055 events2 affected19 at risk
Hyperkalemia
Metabolism and nutrition disorders
CTCAE 4.0
Systematic Assessment
EG0009 events2 affected32 at risk
EG0010 events0 affected7 at risk
EG00221 events3 affected21 at risk
EG0034 events2 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Hypertension
Vascular disorders
CTCAE 4.0
Systematic Assessment
EG00017 events7 affected32 at risk
EG0013 events1 affected7 at risk
EG00265 events7 affected21 at risk
EG00319 events6 affected14 at risk
EG0040 events0 affected7 at risk
EG0058 events2 affected19 at risk
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG00035 events23 affected32 at risk
EG0019 events5 affected7 at risk
EG00214 events10 affected21 at risk
EG00315 events5 affected14 at risk
EG0044 events4 affected7 at risk
EG0057 events3 affected19 at risk
Rash acneiform
Skin and subcutaneous tissue disorders
CTCAE 4.0
Systematic Assessment
EG0007 events4 affected32 at risk
EG0012 events2 affected7 at risk
EG00224 events5 affected21 at risk
EG00313 events5 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
fall
Injury, poisoning and procedural complications
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected21 at risk
EG0033 events1 affected14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected19 at risk
Fatigue
General disorders
CTCAE 4.0
Systematic Assessment
EG00054 events26 affected32 at risk
EG00116 events7 affected7 at risk
EG00233 events16 affected21 at risk
EG00316 events9 affected14 at risk
EG0046 events5 affected7 at risk
EG00518 events8 affected19 at risk
Fever
General disorders
CTCAE 4.0
Systematic Assessment
EG0002 events1 affected32 at risk
EG0010 events0 affected7 at risk
EG0025 events5 affected21 at risk
EG0032 events2 affected14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected19 at risk
Heartburn
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG0001 affected32 at risk
EG0013 events3 affected7 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected19 at risk
Laryngeal hemorrhage
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected7 at risk
EG0025 events5 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Hypoalbumenia
Metabolism and nutrition disorders
CTCAE 4.0
Systematic Assessment
EG00058 events19 affected32 at risk
EG0015 events2 affected7 at risk
EG002183 events15 affected21 at risk
EG00346 events7 affected14 at risk
EG0041 events1 affected7 at risk
EG00513 events2 affected19 at risk
hypocalcemia
Metabolism and nutrition disorders
CTCAE 4.0
Systematic Assessment
EG00010 events7 affected32 at risk
EG0010 events0 affected7 at risk
EG00218 events6 affected21 at risk
EG00310 events4 affected14 at risk
EG0043 events2 affected7 at risk
EG0053 events2 affected19 at risk
Hypokalemia
Metabolism and nutrition disorders
CTCAE 4.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected7 at risk
EG0025 events3 affected21 at risk
EG0032 events2 affected14 at risk
EG0042 events2 affected7 at risk
EG0051 events1 affected19 at risk
Hypomagnesemia
Metabolism and nutrition disorders
CTCAE 4.0
Systematic Assessment
EG0008 events4 affected32 at risk
EG0011 events1 affected7 at risk
EG00214 events6 affected21 at risk
EG0030 events0 affected14 at risk
EG0041 events1 affected7 at risk
EG0053 events1 affected19 at risk
Hyponatrema
Metabolism and nutrition disorders
CTCAE 4.0
Systematic Assessment
EG0007 events6 affected32 at risk
EG0011 events1 affected7 at risk
EG0029 events6 affected21 at risk
EG0037 events4 affected14 at risk
EG0042 events2 affected7 at risk
EG0052 events2 affected19 at risk
Hypophosphatemia
Metabolism and nutrition disorders
CTCAE 4.0
Systematic Assessment
EG0008 events7 affected32 at risk
EG0014 events2 affected7 at risk
EG0025 events3 affected21 at risk
EG00312 events4 affected14 at risk
EG0040 events0 affected7 at risk
EG0058 events2 affected19 at risk
Hypotension
Vascular disorders
CTCAE 4.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected21 at risk
EG0032 events2 affected14 at risk
EG0042 events2 affected7 at risk
EG0051 events1 affected19 at risk
Injection site reaction
Infections and infestations
CTCAE 4.0
Systematic Assessment
EG00033 events23 affected32 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected21 at risk
EG0036 events4 affected14 at risk
EG0041 events1 affected7 at risk
EG00516 events4 affected19 at risk
Insomnia
Psychiatric disorders
CTCAE 4.0
Systematic Assessment
EG00012 events9 affected32 at risk
EG0010 events0 affected7 at risk
EG0029 events3 affected21 at risk
EG0032 events1 affected14 at risk
EG0042 events2 affected7 at risk
EG0052 events2 affected19 at risk
Oral Mucositis
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0032 events1 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Myalgia
Musculoskeletal and connective tissue disorders
CTCAE 4.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0011 events1 affected7 at risk
EG0022 events1 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Nasal Congestion
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected7 at risk
EG0026 events1 affected21 at risk
EG0031 events1 affected14 at risk
EG0041 events1 affected7 at risk
EG0052 events2 affected19 at risk
Nasuea
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG00028 events17 affected32 at risk
EG0018 events4 affected7 at risk
EG0028 events7 affected21 at risk
EG00312 events8 affected14 at risk
EG0045 events3 affected7 at risk
EG00524 events8 affected19 at risk
Neutrophil count decreased
Investigations
CTCAE 4.0
Systematic Assessment
EG0007 events6 affected32 at risk
EG0013 events2 affected7 at risk
EG0023 events2 affected21 at risk
EG0033 events2 affected14 at risk
EG0040 events0 affected7 at risk
EG0054 events1 affected19 at risk
Pain
General disorders
CTCAE 4.0
Systematic Assessment
EG00017 events8 affected32 at risk
EG0013 events2 affected7 at risk
EG00224 events8 affected21 at risk
EG00311 events6 affected14 at risk
EG0048 events5 affected7 at risk
EG0059 events3 affected19 at risk
neuropathy
Nervous system disorders
CTCAE 4.0
Systematic Assessment
EG0003 events2 affected32 at risk
EG0010 events0 affected7 at risk
EG0023 events2 affected21 at risk
EG0032 events1 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Platelet Count Decreased
Investigations
CTCAE 4.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0014 events1 affected7 at risk
EG0025 events2 affected21 at risk
EG0038 events5 affected14 at risk
EG0044 events3 affected7 at risk
EG0055 events1 affected19 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected21 at risk
EG0032 events2 affected14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected19 at risk
Pruritis
Skin and subcutaneous tissue disorders
CTCAE 4.0
Systematic Assessment
EG00017 events7 affected32 at risk
EG0010 events0 affected7 at risk
EG00227 events5 affected21 at risk
EG0036 events3 affected14 at risk
EG0041 events1 affected7 at risk
EG0059 events7 affected19 at risk
Sore throat
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected21 at risk
EG0031 events1 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
Voice Hoarseness
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG0002 events1 affected32 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected21 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected19 at risk
vomiting
Gastrointestinal disorders
CTCAE 4.0
Systematic Assessment
EG00011 events7 affected32 at risk
EG0012 events2 affected7 at risk
EG0022 events2 affected21 at risk
EG0035 events3 affected14 at risk
EG0043 events2 affected7 at risk
EG0057 events4 affected19 at risk
Weight loss
Investigations
CTCAE 4.0
Systematic Assessment
EG00014 events9 affected32 at risk
EG0011 events1 affected7 at risk
EG0024 events3 affected21 at risk
EG0033 events3 affected14 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected19 at risk
Wheeze
Respiratory, thoracic and mediastinal disorders
CTCAE 4.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0011 events1 affected7 at risk
EG0023 events2 affected21 at risk
EG0030 events0 affected14 at risk
EG0042 events2 affected7 at risk
EG0053 events1 affected19 at risk
White Blood Cell Decreased
Investigations
CTCAE 4.0
Systematic Assessment
EG00034 events16 affected32 at risk
EG00119 events4 affected7 at risk
EG00214 events7 affected21 at risk
EG00315 events7 affected14 at risk
EG0042 events2 affected7 at risk
EG00510 events2 affected19 at risk
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D012263
Ribonucleosides
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
66.7
± 10.3
BG00473± 9.7
BG00566.6± 7.5
BG00672± 9.36
65.5
(47 to 84)
BG00470(63 to 90)
BG00566.6(55 to 84)
BG00670(45 to 90)
0
BG0040
BG0051
BG0061
Participants
BG004
7
ParticipantsBG00519
ParticipantsBG006100
Title
Measurements
BG00016
BG0014
BG0029
BG0035
BG0043
BG0058
BG00645
Participants
BG004
7
ParticipantsBG00519
ParticipantsBG006100
Title
Measurements
BG00016
BG0013
BG00212
BG0039
BG0044
BG00510
BG00654
0
BG0040
BG0050
BG0060
Not Hispanic or Latino
BG00031
BG0016
BG00219
BG00314
BG0046
BG00518
BG00694
Unknown or Not Reported
BG0001
BG0011
BG0022
BG0030
BG0041
BG0051
BG0066
0
BG0040
BG0050
BG0060
Asian
BG0005
BG0012
BG0023
BG0031
BG0040
BG0050
BG00611
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0005
BG0011
BG0023
BG0033
BG0040
BG0051
BG00613
White
BG00021
BG0014
BG00214
BG0039
BG0046
BG00515
BG00669
More than one race
BG0001
BG0010
BG0021
BG0031
BG0041
BG0051
BG0065
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0052
BG0062
14
BG0047
BG00519
BG006100
14
OG0047
OG00519
(2.1 to 14.7)
OG0037.8(3.2 to NA)not estimable because the upper confidence limits for the survivor function in this cohort was never less than 50%
OG0044.9(1.4 to NA)not estimable because the upper confidence limits for the survivor function in this cohort was never less than 50%
OG0053.8(2.9 to 6.64)
14
OG0047
OG00519
(2.1 to 14.7)
OG0037.8(3.2 to NA)not estimable because the upper confidence limits for the survivor function in this cohort was never less than 50%
OG0044.9(1.4 to NA)not estimable because the upper confidence limits for the survivor function in this cohort was never less than 50%
OG0053.8(2.9 to 21.8)
14
OG0047
OG00519
(12.9 to 57.4)
OG00314(7.9 to NA)not estimable because the upper confidence limits for the survivor function in this cohort was never less than 50%
OG0045(3.2 to NA)not estimable because the upper confidence limits for the survivor function in this cohort was never less than 50%